Montelukast’s Underrecognized Adverse Drug Events


The US Food and Drug Administration (FDA) first alerted healthcare professionals (HCPs) about a possible association between the use of leukotriene inhibitors and neuropsychiatric events in 2008 and added information to product labels in 2009. The reported events included agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor. While the precaution was extended to all agents in this class (montelukast [Singulair®], zafirlukast [Accolate®], and zileuton [Zyflo®]), particular concern has been raised about montelukast due to its widespread use in both adult and pediatric patients for multiple indications. Montelukast is approved for the chronic treatment of asthma, acute prevention of exercise-induced bronchial constriction, and relief of both perennial and seasonal allergic rhinitis symptoms. Singulair is approved in adults and children 6 months of age and older. Continued concerns about suicidality and neuropsychiatric events with montelukast were again raised at a recent FDA Pediatric Advisory Committee (PAC) meeting in September 2014. Medscape spoke with Sally Seymour, MD, and Erika Torjusen, MD, MHS, both at the Center for Drug Evaluation and Research in the Division of Pulmonary, Allergy, and Rheumatology at the FDA, about the advisory committee meeting, concerns with these agents, and the implications for HCPs.

Medscape: Can you briefly review the concerns presented at the advisory committee meeting about these agents?

Dr Seymour: On September 23, 2014, montelukast [Singulair] was discussed at the PAC meeting as part of a routine pediatric safety review conducted after a drug has new pediatric labeling.

During the open public hearing, a parent who represented numerous groups wanted to raise awareness of the potential for neuropsychiatric events with montelukast. The speaker stated that, despite the FDA’s communication efforts and information in the product label, many physicians are not aware or do not communicate the risk for neuropsychiatric events to patients.

As part of the discussion, the committee reviewed the current montelukast labeling regarding the risk for neuropsychiatric events. Members wanted HCPs to be cognizant of the association with neuropsychiatric events and consider discontinuing montelukast if they occur. The PAC recommended a communication directed at HCPs to raise awareness of the association of neuropsychiatric events. This Medscape interview is a result of the committee’s recommendations.

Medscape: In addition, the committee heard about the available objective data regarding montelukast and neuropsychiatric events. Could you summarize those data? What do we know about these adverse events, what they look like, how acutely they occur, and the populations in which they occur?

Dr Seymour: At the PAC meeting, we briefly summarized the FDA’s previous review of this safety issue. In 2008-2009, we reviewed available data (postmarketing and clinical trial data) to evaluate the risk for neuropsychiatric events with leukotriene modifiers: montelukast, zileuton, and zafirlukast. During this review of spontaneous postmarketing reports, we noted a variety of neurologic or psychiatric adverse events associated with use of these products. Reports included: agitation, aggressive behavior or hostility, anxiousness, depression, disorientation, disturbance in attention, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behavior (including suicide), and tremor. Some of these reports appeared to be consistent with a drug-induced effect. Events were noted in both adults and children, and the onset of events varied.

Based upon these data, the FDA required the manufacturers to add information to the product labels. All of these labels now have a warning/precaution about the risk for neuropsychiatric events.

Medscape: This was a pediatric advisory committee meeting. Were all of these events reported in children, or are adults also experiencing these adverse events?

Dr Seymour: We have reports of children and adults experiencing these types of events. We especially want to reach out to HCPs taking care of children because montelukast is approved for children down to 6 months of age, and detecting these events in children may be more challenging. Small children can’t report side effects, and young children or teenagers may experience changes in behavior or mood that can be mistakenly attributed to a normal phase of development. Therefore, parents and practitioners need an increased level of awareness about the risks of montelukast in these age groups.

Medscape: Are these adverse events reversible with drug discontinuation, and is there a time frame in which they are likely to occur?

Dr Torjusen: The most common adverse events are typically not serious. These events are generally reversible with cessation of therapy. In terms of timing, we have reports following initiation of montelukast and after chronic use.

Medscape: You noted that the committee made a determination that more outreach and strengthening of prescriber warnings was warranted. Were there any other committee recommendations? For example, will there be any requirement to manufacturers to conduct any further studies?

Dr Torjusen: Based on the testimony provided during the open public hearing, the PAC recommended potential strategies for increasing awareness of the neuropsychiatric events that may occur with montelukast. Possibilities raised by the committee included labeling changes, education of providers, and consideration for further studies. The PAC recommendations can be found on our website.

Dr Seymour: When the FDA completed its initial review in 2009 and required the companies to update the product labeling, we did not require clinical trials to further evaluate this issue. Because this is a known safety issue, the FDA does not think that changes to the prescriber information or clinical studies are warranted at this time. The PAC noted that the patient labeling was clear.

Medscape: Given that this is a class-wide concern, should all leukotriene inhibitors be avoided in patients who experience these symptoms in response to one agent? Or is it worth a clinician trying another drug in the same class if it was felt it was really indicated?

Dr Torjusen: Based on the data available, this does appear to be a class effect and is the reason the labeling change was applied to all of the drugs in the class of leukotriene inhibitors. Therefore, if a patient experiences neuropsychiatric symptoms while on one leukotriene inhibitor, we would recommend that they avoid other drugs in the class.

Medscape: Why do you think this now 5-year-old safety issue is not well known by prescribers?

Dr Torjusen: That is a good question. It is possible that awareness of the association between montelukast and neuropsychiatric events has faded. HCPs are inundated with new products and new safety information, and keeping up with all of this can be a challenge. In addition, the types of events experienced are highly variable. Detecting these events in children and young adults can be particularly challenging. Young children may be less able to articulate these experiences, and parents may unknowingly attribute symptoms to be part of developmental changes. Therefore, reminders of important safety concerns may be necessary at times for both patients and providers.

Medscape: What are the key take-home messages for clinicians who are prescribing this class of drugs?

Dr Torjusen: The key take-home message is for HCPs to be aware of the risk for neuropsychiatric events with the use of montelukast. Providers should inform their patients and families that these types of side effects are a possibility with these medications, and they should follow up with their patients after initiation of therapy.

Patients should also notify their HCPs if side effects occur, and HCPs should consider discontinuing therapy if patients develop neuropsychiatric symptoms.

Medscape: Are there resources for patient education that clinicians can and should use?

Dr Torjusen: Certainly, clinicians can always refer to the product label for montelukast [Singulair], which provides safety information for the product. In addition, the patient prescribing information provides useful information on the product, including side effects.

Information about the FDA’s review of the safety issue can be found on the FDA website.

Serious adverse events should also be reported to the FDA MedWatch or by calling the FDA at 1-800-FDA-1088. Patients and HCPs who want more information about specific products can go to the FDA website or contact the FDA [1-888-INFO-FDA].

Asthma Medication Recall Alert: Montelukast Tablets From Camber Pharmaceuticals for Incorrect Drug in Bottle


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The Asthma and Allergy Foundation of America is sharing this press release from the U.S. Food and Drug Administration (FDA) to bring you the latest recall news quickly.


 

The U.S. Food and Drug Administration is warning consumers and health care professionals about a voluntary recall of one lot of Montelukast Sodium Tablets – lot number MON17384, expiration 12/31/2019 – by Camber Pharmaceuticals, Inc., Piscataway, N.J. Sealed bottles labeled as montelukast sodium tablets, 10 milligram, 30-count bottle from Camber were found to instead contain 90 tablets of Losartan Potassium Tablets, 50 mg.

This tablet mix-up may pose a safety risk as taking losartan tablets when not prescribed has the potential to cause renal dysfunction, elevated potassium levels and low blood pressure. This risk is especially high for pregnant women taking the allergy and asthma medication montelukast because losartan, which is indicated to treat high blood pressure, could harm or kill the fetus. The FDA recommends that consumers who have this recalled product should contact their health care provider or pharmacist immediately.

This recall is not related to the recent valsartan recalls that were due to an impurity, N-nitrosodimethylamine (NDMA).

“We want to ensure that patients who take montelukast are aware of this recall due to the serious risks associated with taking losartan in its place,” said Donald D. Ashley J.D., director of the office of compliance in the FDA’s center for drug evaluation and research. “Patients who take prescription drugs expect and deserve to have the medication their doctor prescribed.”

Montelukast is used to prevent wheezing, difficulty breathing, chest tightness and coughing caused by asthma. It is also used to prevent bronchospasm (breathing difficulties) during exercise and to treat the symptoms of seasonal and perennial allergic rhinitis. Montelukast is in a class of medications called leukotriene receptor antagonists (LTRAs) which work by blocking the action of substances in the body that cause the symptoms of asthma and allergic rhinitis.

Losartan is often used alone or in combination with other medications to treat high blood pressure. Losartan is also used to decrease the risk of stroke in people who have high blood pressure and a heart condition called left ventricular hypertrophy (enlargement of the walls of the left side of the heart).

Patients should contact their health care provider or pharmacist to determine if their medicine has been recalled. Patients should also look at the drug name and company name on the label of their prescription bottle. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine.

Montelukast sodium tablets are beige, rounded square-shaped, film coated tablets that are imprinted with “I” on one side and “114” on the reverse. Losartan tablets are white and oval-shaped with the letter “I” imprinted on one side and the number “5” imprinted on the reverse.

Recalled lots of montelukast sodium tablets, USP 10mg have the following information:

  • Label: Montelukast Sodium Tablets 10 mg 30 ct
  • Lot number: MON17384
  • Expiration date: 12/31/2019
  • NDC: 31722-726-30

To date, Camber has not received adverse event reports associated with this recall. The FDA encourages health care professionals and consumers to report adverse events to the FDA’s MedWatch Adverse Event Reporting program:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Duvelisib Approved for Certain Lymphomas


A new oral drug for use in patients with certain blood cancers has been approved by the US Food and Drug Administration (FDA).

The drug, duvelisib (Copiktra, Verstem Oncology), is an oral inhibitor of phosphoinositide 3–kinase (PI3K) and is the first to act as a dual inhibitor of PI3K-delta and PI3K-gamma.

The FDA granted approval for use of duvelisib in adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior therapies. This approval was based on data from the DUO trial, which showed a benefit in progression-free survival.

The FDA also granted an accelerated approval for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who had undergone at least two prior systemic therapies. This accelerated approval was based on overall response rate from the DYNAMO clinical trial. Further data showing clinical benefit are required.

These three disorders — CLL/SLL and FL — are common types of indolent non-Hodgkin lymphomas. It is estimated that 681,000 people are living with non-Hodgkin lymphoma in the United States, including nearly 350,000 patients with CLL/SLL or FL, notes the manufacturer. Many of these patients will eventually experience relapse or develop refractory disease, it adds.

The drug has orphan drug designation and was approved after a priority review.

“Duvelisib is an important addition to the evolving treatment paradigm for patients with CLL/SLL and FL,” said Ian Flinn, MD, PhD, director of the Lymphoma Research Program at Sarah Cannon Research Institute. He was lead investigator of the pivotal studies that led to this approval. Together, the studies involved more than 400 patients.

“I believe [it] will address an unmet need for patients who have limited options once they have progressed after two prior therapies,” he said in a company press release.

Boxed Warning and Adverse Effects

The product carries a boxed warning for four fatal and/or serious toxicities: infections, diarrhea or colitis, cutaneous reactions, and pneumonitis. The manufacturer is implementing an informational risk evaluation and mitigation strategy to provide appropriate dosing and safety information to physicians.

The drug is also associated with adverse reactions that may require dose reduction, treatment delay, or discontinuation. These may include infections, diarrhea or colitis, cutaneous reactions, pneumonitis, hepatotoxicity, neutropenia, and embryo-fetal toxicity.

The most common adverse reactions (reported in ≥20% of patients) were diarrhea or colitis, neutropenia, rash, fatigue, pyrexia, cough, nausea, upper respiratory infection, pneumonia, musculoskeletal pain, and anemia.

Clinical Trial Data

The approval for use in refractory or relapsed CLL/SLL was based on results from a subset of patients who took part in the DYNAMO trial.

This trial compared duvelisib to ofatumumab (Arzerra, Genmab/Novartis) in 319 adult patients with CLL (n = 312) or SLL (n = 7) who had received at least one prior therapy.

The approval was based on a subset of these patients — those who had received at least two prior therapies — because “the benefit:risk appeared greater in this more heavily pretreated population compared to the overall trial population,” the manufacturer explains.

In this subset of patients (95 received buvelisib, 101 received ofatumumab), the median age of the patients was 69 years (range, 40 to 90 years). Among these patients, 46% had received two prior lines of therapy, and 54% had received three or more prior lines.

Efficacy was based on progression-free survival (PFS), as assessed by an independent review committee. The median PFS was 16.4 months with develisib and 9.1 months with ofatumumab (hazard ratio, 0.40).

The accelerated approval for use in patients with previously treated FL was based on the single-arm, multicenter DYNAMO trial, conducted in 83 patients whose conditions were refractory to rituximab and to either chemotherapy or radioimmunotherapy.

This trial excluded patients with grade 3b FL, large cell transformation, prior allogeneic transplant, and prior exposure to a PI3K inhibitor or to a Bruton’s tyrosine kinase inhibitor.

These patients had undergone a median of three prior lines of therapy (range, 1 to 10).

Efficacy was based on overall response rate (35 patients, 42%) and duration of response — 15/35 (43%) maintained the response at 6 months, and 6/35 (17%) maintained the response at 12 months.

FDA Panel Supports Novel Implantable Glucose Sensor


A US Food and Drug Administration (FDA) advisory panel voted unanimously on March 29 to recommend approval of a novel implantable continuous glucose monitor (CGM) for use in adults with diabetes.

Votes of the FDA’s Clinical Chemistry and Clinical Toxicology Devices Panel were 8 to 0 with no abstentions for safety, efficacy, and positive benefit/risk for the Eversense (Senseonics, Inc). If approved, it would be the first-ever implanted CGM available in the United States. A version of device was granted a CE Mark in Europe in 2016, and nearly 1700 patients are currently wearing it in 14 countries.

The fluorescence-based system comprises a sensor that is implanted subcutaneously into the upper arm during a 5- to 10-minute office-based procedure, an external transmitter taped onto the skin above it, and a mobile smartphone or tablet-based application that displays and stores the glucose readings.

The implanted sensor lasts 90 days (with a 7-day grace period), at which point it is removed with another short procedure, and a new one is inserted on the opposite arm. In contrast, most current external CGMs are approved only for 6 to 14 days. (The European device is approved for 180 days.)

As with other CGMs, the Eversense provides real-time glucose readings every 5 minutes, glucose trend information, and alerts for high and low blood glucose levels. In contrast to current CGMs, the device itself also vibrates to alert the user to high and low glucose levels, even when the reader isn’t nearby.

Unlike the Dexcom and Abbott Libre CGMs, the proposed indication for the Eversense is for adjunctive use, meaning the user would still need to perform fingerstick monitoring for treatment decisions, in addition to twice-daily calibrations.

A long-lasting implantable CGM addresses an unmet need, according to endocrinologist Jeremy H. Pettus, MD, from the University of California, San Diego, speaking on behalf of Senseonics. At this time, 76% of patients with type 1 diabetes are not using CGMs, and 27% who start, discontinue them within a year because of problems with accuracy, insertion or adhesives, cost, or discomfort.

“There is a need for more CGM options to increase patient access,” Pettus said. That notion was echoed by a majority of 19 speakers who addressed the panel during a public comment session, several of them study subjects for whom travel had been paid by the company.

Panel member George Grunberger, MD, medical director of the Grunberger Diabetes Institute, Bloomfield Hills, Michigan, told Medscape Medical News, “Clearly, this expands the pool of people. There are reasons why patients haven’t used the currently available systems. The more options the better. There’s no one that fits everybody. Some people had bad experiences, some are physically challenged in placement, or the sensor doesn’t stick. There are many issues.”

If approved, Grunberger said, the Eversense will “expose more patients and more clinicians to the world of CGM.”

Accuracy Demonstrated in Pivotal Trial

The Eversense clinical program included three prospective clinical trials: PRECISE, which was conducted in 81 patients in Europe for the 180-day version approved there and used as supportive data for the FDA application; the pivotal PRECISE II, which was a 90-day US-based trial involving 90 patients; and PRECISION, which was a 90-day trial in 35 patients that tested a version of the system with revised features. In addition, data on the European patients are being collected in a registry.

In the nonrandomized, single-arm, multicenter PRECISE II, the system was accurate through 90 days, with an absolute mean relative difference of 8.5% compared with laboratory reference glucose measures, and 87% of the readings came within either 15 mg/dL or 15% of reference (the so-called “15/15 rule”).

In addition, the system detected 96% of hypoglycemic excursions and 98% of hyperglycemic excursions, and 91% of the sensors functioned for the entire 90 days.

As with other CGMs, accuracy was somewhat less on day 1, with just 77% of readings meeting the 15/15 rule, Senseonics Chief Executive Officer Tim Goodnow, PhD, reported.

In PRECISION, patients wore two Eversense devices to compare a smaller second-generation transmitter that is now part of the proposed system with the first-generation transmitter used in PRECISE II, and 85% of readings met the 15/15 rule.

Some Safety Issues Mitigated With Design Changes

There were no device-related adverse events in either PRECISE II or PRECISION. In one patient in PRECISE II, the sensor couldn’t be removed after 2 attempts, and the patient underwent surgery under general anesthesia to have it removed. In two other events, the removed devices were found to have missing end caps that were presumed to have been left in the patients’ arms but were deemed not to present a danger.

Subsequent to that, revisions were made to both the sensor end caps and the blunt dissector tool to reduce those risks. Changes were also made to the glucose determination algorithm after PRECISE II, but that did not affect the sensor’s output, according to Goodnow.

One of the questions FDA posed to the panel was whether they had concerns about the lack of data for the Eversense subsequent to the revisions. The consensus was that more data were needed, but that they could be collected postmarketing.

Panel member Kathleen Wyne, MD, PhD, an endocrinologist in Columbus, Ohio, told Medscape Medical News, “The algorithm seems to be an improvement, as do the smaller transmitter, the end cap and insertion device. I think the committee felt comfortable that those were positive changes. I do share the concern that we do need to test out the new device, but they really look like positive changes, so that’s why it’s reasonable to go ahead with the new device as it is, but obviously collect data as it comes into use.”

There were no infections in either PRECISE II or PRECISION, and overall infection rates are less than 1%.

The Eversense would be contraindicated for use with intravenously administered (but not dietary) mannitol or sorbitol, because those can cause falsely elevated blood glucose readings. In addition, the proposed label would also include a warning about tetracyclines, which can falsely lower the readings.

Clinician Trainings Planned

Senseonics is developing a certification program to train clinicians in the insertion procedure, including a didactic session led by company-approved trainers, practice with simulated skin, and observed initial insertions and removals. Several endocrinologists who had participated in the studies testified that the procedure was easy to learn. Steven J. Russell, MD, from Harvard Medical School, Boston, Massachusetts, noted that as a diabetes-focused endocrinologist, “it’s nice to do procedures again.”

Senseonics is proposing a US postapproval study following serial insertions and removals for 2 years, involving 175 patients at up to 20 clinical sites. The primary safety endpoint would be the rate of device-related and insertion/removal procedure-related serious adverse events through 12 months of 7% or below, and the primary effectiveness endpoint, time in range (70 – 180 mg/dL) at month 12 vs month 1.

Several panelists also endorsed the establishment of a US-based registry similar to the one in Europe to track unexpected outcomes. Several panel members also advised collecting data on patient satisfaction. Grunberger added that, given that this device would a new element to usual endocrinology practice, clinician satisfaction should be assessed as well.

FDA advisory panel members are vetted for conflicts of interest and waivers are granted if necessary. None were required for this meeting.

63% of Americans Actively Avoid Drinking Soda


Story at-a-glance

  • Sixty-three percent of Americans actively try to avoid soda, compared to 41 percent in 2002
  • Rates of soda consumption have been dropping for decades, and Americans now consume about the same amount they did back in 1986
  • Coca-Cola is engaging in an intensive marketing ploy to “reintroduce” Coke, using smaller serving sizes and personalized cans to target teens
  • While carbonated soda sales fell 2 percent in 2013, Diet Coke sales dropped 7 percent amidst fears of aspartame’s health risks
  • Adolescent rats fed sugary drinks for one month had both impaired memory and trouble learning

Americans are finally starting to realize the dangers of soda, with nearly two-thirds (63 percent) saying they actively try to avoid soda in their diet, a new Gallup poll revealed.1

This is a significant increase from 2002, when only 41 percent were trying to avoid soda, and a clear sign that, as TIME reported, “the soda craze is going flat.”2

Soda Consumption Falls to Lowest Level in Decades

The soda industry is a $75-billion market,3 an industry that reached its greatest heights in the US during the 1980s and 1990s, when Coca-Cola began pushing larger drink sizes and “upsizing.” Fountain drink sizes grew more than 50 percent by 1990, and in 1994, the 20-ounce plastic bottle was introduced in the US.

As people drank more and more soda, rates of obesity and diabetes soared, and while the soda industry still denies to this day any connection, research suggests otherwise. The “supersized” mentality seems to have backfired for Coca-Cola and other beverage companies, because as the health risks become clear, sales have been on a steady downward spiral.

As Businessweek reported:4

“For decades, soft-drink companies saw consumption rise. During the 1970s, the average person doubled the amount of soda they drank; by the 1980s it had overtaken tap water. In 1998, Americans were downing 56 gallons of the stuff every year—that’s 1.3 oil barrels’ worth of soda for every person in the country.

And then we weren’t as thirsty for soda anymore, and there were so many new drink options that we could easily swap it out for something else. Soft-drink sales stabilized for a few years…

In 2005 they started dropping, and they haven’t stopped. Americans are now drinking about 450 cans of soda a year, according to Beverage Digest, roughly the same amount they did in 1986.”

Coca-Cola Seeks to ‘Reintroduce’ Coke to Teen Market, and in ‘Guilt-Free’ Sizes

Part of Coca-Cola’s plan to bring soda back is, ironically, introducing smaller sizes, a strategy they believe might reposition Coke so “people stop feeling guilty when they drink it, or, ideally come to see a Coke as a treat.”

Smaller, 7.5-ounce minicans and 8-ounce glass bottles have been selling well. Even Sandy Douglas, president of Coca-Cola North America, says he limits himself to one 8-ounce glass bottle of regular Coke in the morning. Any more would be too many calories, he told Businessweek.

Meanwhile, Coca-Cola decided to target the teen market directly this summer. Teens, while notorious for their soft-drink consumption, have been quickly bailing ship and opting for energy drinks instead.

So Coca-Cola printed the 250 most common teen names on Coke bottles, hoping to entice teens with the “personalized” drinks. It worked. Sales increased by 1 percent in North America in the last three months.5

Beverage consultant Mike Weinstein, former president of A&W Brands, even noted that he goes right into high schools to find out whether teens can identify soda company slogans.

Yet, there seems to be a growing realization within the industry that, as American attitudes about diet change, and more people seek to reduce added sugar and sugary drinks in their diets, appealing to the “healthier” side of their image is needed.

And, here, too, Coca-Cola is quick to respond. They’ve invested heavily in small “healthy” beverage companies like Fuze tea, Zico coconut water, and organic Honest Tea. Coca-Cola also owns Odwalla and Simply Orange juices, Glaceau Vitaminwater, and Core Power sports drinks.

Coca-Cola Chairman and Chief Executive Officer Muhtar Kent has no intention of letting Coca-Cola’s brands, and its namesake product Coke, fall by the wayside.

A $1-billion two-year marketing blitz’s sole goal is to drive its “sparkling” division back to its former glory. And in case you were wondering… its healthy-sounding “sparkling” division includes soda, which is completely delusional.

Your Brain on Soda

When you drink soda, numerous changes happen in your body, including in your brain. A new animal study, presented at the Annual Meeting of the Society for the Study of Ingestive Behavior, found that sugary beverages may be particularly damaging to the brains of adolescents, one of the key age groups soda companies are trying to “court.”

Both adult and adolescent rats were fed sugary beverages for one month. They then were tested for cognitive function and memory.

While the adult rats did okay, the adolescent rats fed sugary drinks had both impaired memory and trouble learning.6 Next, the researchers plan to study whether soda leads to inflammation in the brain’s hippocampus, which is crucial for memory and learning.

Diet Coke Sales Plummet Amidst Aspartame Health Concerns

Diet Coke may not contain sugar, but that certainly doesn’t make it a better choice than regular soda. Here, too, Americans are catching on to the risks involved, especially in regard to the artificial sweetener aspartame. Businessweek, reporting on the decline in Coca-Cola’s sales, noted that while carbonated soda sales fell 2 percent in 2013, Diet Coke sales dropped 7 percent.

This, they said, was “almost entirely the result of the growing unpopularity of aspartame amid persistent rumors that it’s a health risk.”7 Rumors? Far from it. Research continues to pour in revealing proven health dangers to aspartame.

Among them, a recent commentary that reviewed the adequacy of the cancer studies submitted by G.D. Searle in the 1970s to the US Food and Drug Administration (FDA) for market approval.8

Their review of the data found that the studies did not prove aspartame’s safety, while other recent research suggests aspartame has potential carcinogenic effects. The researchers noted:

“Taken together, the studies performed by G.D. Searle in the 1970s and other chronic bioassays do not provide adequate scientific support for APM safety.

In contrast, recent results of life-span carcinogenicity bioassays on rats and mice published in peer-reviewed journals, and a prospective epidemiological study, provide consistent evidence of APM’s carcinogenic potential.

On the basis of the evidence of the potential carcinogenic effects of APM herein reported, a re-evaluation of the current position of international regulatory agencies must be considered an urgent matter of public health.”

You may also be surprised to learn that research has repeatedly shown that artificially sweetened no- or low-calorie drinks and other “diet” foods actually tend to stimulate your appetite, increase cravings for carbs, and stimulate fat storage and weight gain.

A report published in the journal Trends in Endocrinology & Metabolism highlighted the fact that diet soda drinkers suffer the same exact health problems as those who opt for regular soda, such as excessive weight gain, type 2 diabetes, cardiovascular disease, and stroke.9 For the record, Coca-Cola maintains aspartame is a “safe, high-quality alternative to sugar.” Clearly they’ve not reviewed the hundreds of studies on this artificial sweetener demonstrating its harmful effects…

What Happens When You Drink Soda?

Soda is on my list of the absolute worst foods and drinks you can consume. Once ingested, your pancreas rapidly begins to create insulin in response to the sugar. A 20-ounce bottle of cola contains the equivalent of 16 teaspoons of sugar in the form of high fructose corn syrup (HFCS). In addition to contributing to insulin resistance, the rise in blood sugar is quite rapid. Here’s a play-by-play of what happens in your body upon drinking a can of soda:

  • Within 20 minutes, your blood sugar spikes, and your liver responds to the resulting insulin burst by turning massive amounts of sugar into fat.
  • Within 40 minutes, caffeine absorption is complete; your pupils dilate, your blood pressure rises, and your liver dumps more sugar into your bloodstream.
  • Around 45 minutes, your body increases dopamine production, which stimulates the pleasure centers of your brain – a physically identical response to that of heroin, by the way.
  • After 60 minutes, you’ll start to have a blood sugar crash, and you may be tempted to reach for another sweet snack or beverage.

As I’ve discussed on numerous occasions, chronically elevated insulin levels (which you would definitely have if you regularly drink soda) and the subsequent insulin resistance is a foundational factor of most chronic disease, from diabetes to cancer. Today, while many Americans are cutting back on sugary drinks, soda remains a dietary mainstay for many. Along with energy drinks and sports drinks, soda is among the top 10 sources of calories in the US diet (number four on the list, to be exact),10 and, in 2012, Gallup found that 48 percent of Americans said they drink at least one glass of soda a day,11 with proven detrimental impacts to their health.

Some Advice for Coca-Cola? Get Ready for a Class-Action Suit

Some advice for Coke, plan your budget to include a class-action lawsuit similar to those filed against the tobacco industry. These products are now well linked to the obesity epidemic and chronic disease. Coca-Cola admits to targeting teens (and has previously targeted children through in-school advertising and product placement). Now, they are making attempts to rebrand Coke with a new, healthier image. Their new “Coke Life,” a low-calorie, low-sugar soda in a green can, no less, was designed to “quiet critics,” as it contains less sugar and no aspartame.12 Yet this new green-washed soda is just basically a cigarette with a filter.

Then there is Coca-Cola’s even more insidious side. Investigative journalist Michael Blanding revealed in his book, The Coke Machine — The Dirty Truth Behind the World’s Favorite Soft Drink, that Coca-Cola bottling plants in India have dramatically lowered the water supply, drying up wells for local villagers while also dumping cadmium, chromium, and other carcinogens into the local environment. Similar claims have been made in Mexico. In many third-world countries, they already don’t have access to clean water, making soda their only choice for a non-contaminated beverage. As the demand for soda grows, the bottling plants increase, further taxing the water supplies left, in a vicious and dangerous cycle.

Join the Growing Number of People Saying ‘No’ to Soda

In order to break free of your soda habit, first be sure you address the emotional component of your food cravings using tools such as the Emotional Freedom Technique (EFT). More than any traditional or alternative method I have used or researched, EFT works to overcome food cravings and helps you reach dietary success. Be sure to check out Turbo Tapping in particular, which is an extremely effective and simple tool to get rid of your soda addiction in a short amount of time.

If you still have cravings after trying EFT or Turbo Tapping, you may need to make some changes to your diet. My free nutrition plan can help you do this in a step-by-step fashion. Remember, nothing beats pure water when it comes to serving your body’s needs. If you really feel the urge for a carbonated beverage, try sparkling mineral water with a squirt of lime or lemon juice, or sweetened with stevia or Luo Han, both of which are safe natural sweeteners. Remember, if you struggle with high blood pressure, high cholesterol, diabetes, or extra weight, then you have insulin sensitivity issues and would likely benefit from avoiding ALL sweeteners.

Sweetened beverages, whether it’s sweetened with sugar, HFCS, naturally occurring fructose, or artificial sweeteners like aspartame, are among the worst culprits in the fight against obesity and related health problems, including diabetes and heart and liver disease, just to name a few. Ditching ALL of these types of beverages can go a long way toward reducing your risk for chronic health problems and weight gain, not to mention your exposure to potentially cancer-causing additives like caramel coloring and aspartame.

Source:mercola.com

OpenZika Researchers Continue Calculations and Prepare for Next Stage


Summary
The OpenZika researchers are continuing to screen millions of chemical compounds as they look for potential treatments for the Zika virus. In this update, they report on the status of their calculations and their continuing work to spread the word about the project.

While the Zika virus may not be getting the continuous press coverage that it received in 2015 and 2016, it is still a threat to the health of people across the globe. New infections continue to be reported in both South America and North America, and medical workers are just beginning to assess the effects of the virus on young children whose mothers were infected while pregnant.Project Background

The search for effective treatments is crucial to stemming the tide of the virus. In addition to the OpenZika project, several other labs are doing cell-based screens with drugs already approved by the US Food and Drug Administration (FDA) agency, but few to none of the “hit” compounds that have been identified thus far are both potent enough against Zika virus and also safe for pregnant women.

Also, there are a number of efforts underway to develop a vaccine against the Zika virus. However, vaccines do not help people who already have the infection. It will be several years before they are proven effective and safe, and before enough doses can be mass produced and distributed. And even after approved vaccines are available and distributed to the public, not all people will be vaccinated. Consequently, in the meantime and in the future, cures for Zika infections are needed.

Progress on choosing compounds for lab testing

ZIKV NS3 helicase bound to RNA with the predicted binding modes of five approved drugs (from our second set of candidates) selected by virtual screening. These candidates are shown as surfaces with different shades of green. The identification of these candidates and the video were made by Dr. Alexander L. Perryman.

We began the analysis phase of the project by focusing on the results against the apo NS3 helicase crystal structure (apo means that the protein was not bound to anything else, such as a cofactor, inhibitor, or nucleic acid) to select our first set of candidates, which are currently being assayed by our collaborator at University of California San Diego, Dr. Jair L. Siqueira-Neto, using cell-based assays. The NS3 helicase is a component of the Zika virus that is required for it to replicate itself.

In the second set of screening results that we recently examined, we used the new crystal structure of NS3 helicase bound to RNA as the target (see the images / animation above). Similar to the first set of candidates, we docked approximately 7,600 compounds in a composite library composed of the US Food and Drug Administration-approved drugs, the drugs approved in the European Union, and the US National Institutes of Health clinical collection library against the new RNA-bound structure of the helicase. Below are the results of this second screening:

  • 232 compounds passed the larger collection of different energetic and interaction-based docking filters, and their predicted binding modes were inspected and measured in detail.
  • Of the compounds that were inspected in detail, 19 unique compounds passed this visual inspection stage of their docked modes.
  • From the compounds that passed the visual inspection, 9 passed subsequent medicinal chemistry-based inspection and will be ordered soon.

Status of the calculations

In total, we have submitted 2.56 billion docking jobs, which involved the virtual screening of 6 million compounds versus 427 different target sites. We have already received approximately 1.9 billion of these results on our server. (There is some lag time between when the calculations are performed on your volunteered machines and when we get the results, since all of the results per “package” of approximately 10,000 different docking jobs need to be returned to World Community Grid, re-organized, and then compressed before sending them to our server.)

Except for a few stragglers, we have received all of the results for our experiments that involve docking 6 million compounds versus the proteins NS1, NS3 helicase (both the RNA binding site and the ATP site), and NS5 (both the RNA polymerase and the methyltransferase domains).  We are currently receiving the results from our most recent experiments against the NS2B / NS3 protease.

A new stage of the project

We just finished preparing and testing the docking input files that will be used for the second stage of this project. Instead of docking 6 million compounds, we will soon be able to start screening 30.2 million compounds against these targets. This new, massive library was originally obtained in a different type of format from the ZINC15 server. It represents almost all of “commercially available chemical space” (that is, almost all of the “small molecule” drug-like and hit-like compounds that can be purchased from reputable chemical vendors).

The ZINC15 server provided these files as “multi-molecule mol2” files (that is, many different compounds were contained in each “mol2” formatted file). These files had to be re-formatted (we used the Raccoon program from Dr. Stefano Forli, who is part of the FightAIDS@Home team) by splitting them into individual mol2 files (1 compound per file) and then converting them into the “pdbqt” docking input format.

We then ran a quick quality control test to make sure that the software used for the project, called AutoDock Vina, could properly use each pdbqt file as an input. Many compounds had to be rejected, because they had types of atoms that cause Vina to crash (such as silicon or boron), and we obviously don’t want to waste the computer time that you donate by submitting calculations that will crash.

By splitting, reformatting, and testing hundreds of thousands of compounds per day, day after day, after approximately six months this massive new library of compounds is ready to be used in our OpenZika calculations. Without the tremendous resources that World Community Grid volunteers provide for this project, we would not even dream of trying to dock over 30 million compounds against many different targets from the Zika virus. Thank you all very much!!!

For more information about these experiments, please visit our website.

Publications and Collaborations

Our PLoS Neglected Tropical Diseases paper, “OpenZika: An IBM World Community Grid Project to Accelerate Zika Virus Drug Discovery,” was published on October 20, and it has already been viewed over 4,000 times. Anyone can access and read this paper for free. Another research paper “Illustrating and homology modeling the proteins of the Zika virus” has been accepted by F1000Research and viewed > 3800 times.

A group from Brazil, coordinated by Prof. Glaucius Oliva, has contacted us because of our PLoS Neglected Tropical Diseases paper to discuss a new collaboration to test the selected candidate compounds directly on enzymatic assays with the NS5 protein of Zika virus. They have solved two high-resolution crystal structures of ZIKV NS5, which have been recently released on the PDB (Protein Data Bank) (PDB ID: 5TIT and 5U04).

Our paper entitled “Molecular Dynamics simulations of Zika Virus NS3 helicase: Insights into RNA binding site activity” was just accepted for publication in a special issue on Flaviviruses for the journal Biochemical and Biophysical Research Communications. This study of the NS3 helicase system helped us learn more about this promising target for blocking Zika replication. The results will help guide how we analyze the virtual screens that we already performed against NS3 helicase, and the molecular dynamics simulations generated new conformations of this protein that we will use as input targets in new virtual screens that we perform as part of OpenZika.

These articles are helping to bring additional attention to the project and to encourage the formation of new collaborations.

Additional News

We have applied and been accepted to present “OpenZika: Opening the Discovery of New Antiviral candidates against Zika Virus and Insights into Dynamic behavior of NS3 Helicase” to the 46th World Chemistry Congress. The conference will be held in Sao Paulo, Brazil, on July 7-14.

Dr. Sean Ekins has hired a postdoc and a master level scientist who will get involved with the OpenZika project. We have also started to collate literature inhibitors from Zika papers.

Also, Drs. Sean Ekins and Carolina Andrade have offered to buy some of the candidate compounds that we identified in the virtual screens from OpenZika, so that they can be assayed in the next round of tests.

Fundraising

Dr. Alex Perryman models an OpenZika shirt. Profits from the sale of OpenZika merchandise go to purchasing compounds for lab testing. (Photo by Keith Bratcher, courtesy of Rutgers University)

Thank you to anyone who has visited our store on Zazzle to check out OpenZika merchandise such as T-shirts, polo shirts, mugs, buttons, mouse pads, and phone cases. All profits from the sale of this merchandise will go toward buying compounds for lab testing. Drs. Alex Perryman and Sean Ekins have bought OpenZika shirts for themselves. Alex likes the polo style version the best, and he recommends getting the white or gray shirts. But avoid the red shirts, since the OpenZika logo does not stand out as well, especially after it is washed (Alex learned this the hard way).

The OpenZika team is working on grants from the National Institutes of Health, CNPq (a Brazilian funding agency), and other organizations to try raise funds for purchasing and testing compounds.

Outreach

We have been working hard to promote the project, and we continue to look for additional opportunities. Below is a list of our most recent outreach efforts.

  • Dr. Carolina Horta Andrade gave one invited lecture at the 27th annual Institute of Biology Week, at Federal University of Goias, Brazil, to biology and pharmacy students and to the general public regarding the “Design and discovery of new drug candidates for the Zika and Dengue Viruses and OpenZika” (November, 2016).
  • Dr. Carolina Horta Andrade has been elected as an Affiliated Member of the Brazilian Academy of Sciences. She also gave a talk at the Federal University of Minas Gerais, Brazil, to researchers from many different fields of science and to authorities, in which she discussed OpenZika (October 2016).
  • Dr. Melina Mottin, one of the OpenZika team members, presented a poster and gave an oral presentation, titled “OpenZika: an open science collaboration project to discover drug candidates against Zika virus,” at the 8th Brazilian Symposium on Medicinal Chemistry, held in Búzios, Rio de Janeiro, Brazil, from November 27-30, 2016.
  • Dr. Melina Mottin also gave an invited lecture at the Federal University of Rio Grande do Sul, Brazil, at the Post-Graduation Program in Chemistry, to chemistry and pharmacy Ph.D. students and to the general public regarding “Identification of Drug Candidates for Zika virus using Virtual Screening and Molecular Dynamics Simulations,” in which she discussed the OpenZika project (December 2016).
  • Dr. Sean Ekins attended the National Institutes of Health (NIH) “Rare disease day” (February 27, 2017) and also the Gordon Research Conference on Tropical Infectious Diseases (March 12-17 2017).

 

We are very grateful for all of the volunteers who are donating their unused computing time to this project!  Thank you very much!!

Source:https://www.worldcommunitygrid.org

FDA warns parents against using teething tablets and gels.


Story highlights

  • The FDA is warning caregivers to stop using homeopathic teething tablets and gels
  • CVS has pulled the products from its shelves

Parents may have fewer options to soothe their teething child.

The US Food and Drug Administration is warning caregivers to stop using homeopathic teething tablets and gels.
Hyland’s, the company that says it has the best-selling version of the tablets, stands by it, and there is no recall. But CVS, one of the drug store chains that sells Hyland’s, Baby Orajel Naturals and its own version of the product, has pulled them from the shelves.
Confused about what you should do to help your teething child?
Here’s what you need to know.

What are homeopathic teething tablets and gels?

These tablets have been around since the early 1900s and temporarily provide relief to a baby who’s getting their first teeth. Hyland’s tablets “make nights bearable, days livable, and truly make the teething years way more groovy,” it says on its website.
In the case of Hyland’s, the active ingredients are calcarea phosphorica, which helps with teeth formation; chamomilla, meant to help with the baby’s irritability; coffea cruda, to help the baby’s sleeplessness; and belladonna, commonly known as deadly nightshade, which helps ease the redness, inflammation and discomfort from teething.

Why is the FDA concerned?

The FDA is looking into reports of adverse events related to the products, including children who may have had seizures after using them. The agency warns that the tablets and gels “may pose a risk” to infants and advises parents to take their child to a doctor immediately if they experience these seizures or difficulty breathing, lethargy, muscle weakness, excessive sleepiness, constipation, skin flushing, agitation and/or constipation.

What else is the FDA doing?

The FDA is testing samples of the products. It says it will let the public know what it finds.
The products are not FDA-approved for safety or efficacy.
An administration news release adds that it is “not aware of any proven health benefits of the products.”

What has the FDA done in the past?

The FDA issued a safety alert about the tablets in 2010. Hyland’s did issue a recall at that time.
Baby's teeth: What you should know

The ingredient of concern in 2010 was belladonna. After lab testing, the FDA said it found inconsistent amounts of the ingredient in the tablets. The agency also had reports of adverse events related to using the products that were consistent with belladonna toxicity. The FDA also was concerned because the bottles didn’t have child-resistant caps.

Why doesn’t Hyland’s agree?

On its website, Hyland’s says, “We are fully cooperating with FDA’s inquiry and we’re providing them with all the data we have. We also hope to learn from FDA what facts, if any, the Agency has based its action on.
“We test our products for their belladonna content as well as other tests including microbial contamination. We also have a program to monitor, investigate and trend all safety reports on any of our products.”
Also on its website, Hyland’s says that millions of children have been helped by these products since they were introduced to the US market in 1945.
The company’s director of scientific affairs, Dr. Iris Bell, writes on the website that the amount of belladonna alkaloids is “THOUSANDS OF TIMES below” the therapeutic amounts of the ingredient used in some conventional medicines.

What has the rest of the industry done?

CVS voluntarily withdrew all of its homeopathic teething products from its online and retail stores on Monday, after the FDA issued its warning.

What do others think?

The American Academy of Pediatrics’ HealthyChildren.org has warned parents to stay away from teething tablets that contain belladonna and gels with benzocaine, citing the FDA warnings and the potential side effects.

What’s a caregiver to do?

The American Academy of Pediatrics suggests that parents massage the child’s gums with a clean finger when a baby is in pain.
A caregiver could also give the child a solid teething ring, rather than a liquid-filled teething ring.
Other options include a clean, wet washcloth that is chilled in the freezer for about 15 to 30 minutes.
Join the conversation

Frozen bananas or berries can also help if the child is eating solid foods. A frozen bagel is an alternative. Or, if the child is older than 6 to 9 months, try a cotton sock rolled up tightly.

A weight-appropriate dose of acetaminophen may also help, but ask your child’s doctor about what that right

‘Tentative’ FDA Nod to Trokendi XR for Migraine Prevention


The US Food and Drug Administration (FDA) has granted tentative approval to expand the label for an extended-release formulation of topiramate (Trokendi XR, Supernus Pharmaceuticals), approved for epilepsy, to include prophylaxis of migraine headache in adults, the company announced.

The approval of the company’s Supplemental New Drug Application (sNDA) is tentative because while the FDA has determined that the drug meets all the required quality, safety, and efficacy standards for approval, it is subject to pediatric exclusivity, which expires March 28, 2017, the company reports in a press release August 22.

Final approval may not be made effective until this exclusivity period has expired, the release notes.

“We will continue to work with the FDA to gain final approval upon the expiration of pediatric exclusivity,” said Jack Khattar, president and chief executive officer of Supernus Pharmaceuticals, in a press release. “We are prepared and ready to launch the migraine indication upon receiving full FDA approval.”

Supernus further announced that the FDA has granted final approval to expand the label for Trokendi XR for monotherapy treatment of partial-onset seizures to include patients 6 years and older, rather than 10 years and older, as well as adults.

In addition to now being indicated for initial monotherapy in patients 6 years and older with partial-onset or primary generalized tonic-clonic seizures, Trokendi XR is also indicated as adjunctive therapy in these patients and in those 6 years of age and older with seizures associated with Lennox-Gastaut syndrome.

The product is available in 25-mg, 50-mg, 100-mg, and 200-mg extended-release capsules.

Another extended-release topiramate (Qudexy, Upsher-Smith) received FDA approval as an initial monotherapy in patients as young as 2 years with partial-onset seizures or primary generalized tonic-clonic seizures in June 2015.
It was previously approved in March 2014 for use as initial monotherapy in patients 10 years of age and older with partial-onset seizures or primary generalized tonic-clonic seizures, and as adjunctive therapy in patients 2 years of age or older with partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome.

FDA allows marketing of new device to help the blind process visual signals via their tongues


The Food and Drug Administration today allowed marketing of a new device that when used along with other assistive devices, like a cane or guide dog, can help orient people who are blind by helping them process visual images with their tongues.

The BrainPort V100 is a battery-powered device that includes a video camera mounted on a pair of glasses and a small, flat intra-oral device containing a series of electrodes that the user holds against their tongue. Software converts the image captured by the video camera in to electrical signals that are then sent to the intra-oral device and perceived as vibrations or tingling on the user’s tongue. With training and experience, the user learns to interpret the signals to determine the location, position, size, and shape of objects, and to determine if objects are moving or stationary.

“Medical device innovations like this have the potential to help millions of people,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health. “It is important we continue advancing device technology to help blind Americans live better, more independent lives.”

According to the National Institutes of Health’s National Eye Institute (NEI), in 2010 more than 1.2 million people in the United States were blind. NEI projects that number of Americans who are blind will rise to 2.1 million by 2030 and 4.1 million by 2050.

The FDA reviewed the data for the BrainPortV100 through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally-marketed device.

Clinical data supporting the safety and effectiveness of the BrainPort V100 included several assessments, such as object recognition and word identification, as well as oral health exams to determine risks associated with holding the intra-oral device in the mouth. Studies showed that 69 percent of the 74 subjects who completed one year of training with the device were successful at the object recognition test. Some patients reported burning, stinging or metallic taste associated with the intra-oral device. There were no serious device-related adverse events.

BrainPort is manufactured by Wicab, Inc., in Middleton, Wisc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

The FDA Just Released Scary New Data on Antibiotics And Farms


 

A close-up of the methicillin-resistant Staphylococcus aureus (MRSA) bacteria, which is commonly found on supermarket pork.

Back in April 2012, the Food and Drug Administration launched an effort to address a problem that had been festering for decades: the meat industry’s habit of feeding livestock daily low does of antibiotics, which keeps animals alive under stressful conditions and may help them grow faster, but also generates bacterial pathogens that can shake off antibiotics, and make people sick.

The FDA approached the task gingerly: It asked the industry to voluntarily wean itself from routine use of “medically important” antibiotics—those that are critical to human medicine, like tetracycline. In addition to the light touch, the agency plan included a massive loophole: that while livestock producers should no longer use antibiotics as a growth promoter, they’re welcome to use them to “prevent” disease—which often means using them in the same way (routinely), and at the same rate. How’s the FDA’s effort to ramp down antibiotic use on farms working? Last week, the FDA delivered an early look, releasing data for 2013, the year after it rolled out its plan. The results are … scary.

FDA

Note that use of medically important antibiotics actually grew 3 percent in 2013 compared to the previous year, while the industry’s appetite for non-medically import drugs, which it’s supposed to be shifting to, shrank 2 percent. A longer view reveals an even more worrisome trend: between 2009 and 2013, use of medically important drugs grew 20 percent.And the FDA data show that these livestock operations are particularly voracious for the same antibiotics doctors prescribe to people. Farms burn through 9.1 million kilograms of medically important antibiotics vs. 5.5 million kilograms of ones not currently used in human medicine. That means about 62 percent of their total antibiotic use could be be helping generate pathogens that resist the drugs we rely on. (According to Natural Resources Defense Council’sAvinash Kar, 70 percent of medically important antibiotics sold in the US go to farms.)

The report also delivers a stark view into just how routine antibiotics have become on farms.

FDA

Note that 74 percent of the medically important drugs being consumed on farms are delivered through feed, and another 24 percent go out in water. That means fully 95 percent is being fed to animals on a regular basis, not being given to specific animals to treat a particular infection. Just 5 percent (4 percent via injection, 1 percent orally) are administered that way.

Anyone wondering which species—chickens, pigs, turkeys, or cows—get the most antibiotics will have to take it up with the FDA. The agency doesn’t require companies to deliver that information, so it doesn’t exist, at least not in publicly available form. The FDA only began releasing any information at all on livestock antibiotic use in very recent years, after having its hand forced by a 2008 act of Congress.

Meanwhile, at least 2 million Americans get sick from antibiotic-resistant bacteria each year, and at least 23,000 of them die, the Centers for Disease Controlestimates. And while all of that carnage can’t be blamed on the meat industry’s drug habit, it does play a major role, as the CDC makes clear in this handy infographic.

CDC