FDA Label Changes Underline Risks With Ezogabine


The US Food and Drug Administration (FDA) has announced approval of changes to labeling for the antiseizure medication ezogabine (Potiga, Valeant Pharmaceuticals International) to underline previously reported risks for retinal abnormalities, potential vision loss, and skin discoloration, all of which may become permanent.

“The revised label includes a new boxed warning, the most serious type of warning FDA gives,” because of this risk for retinal abnormalities, a statement from FDA notes. “We advise that Potiga use be limited to patients who have not responded adequately to several alternative therapies to decrease the frequency of seizures, or epilepsy, and for whom the benefits of treatment outweigh the risks.”

The risks were previously described in a Drug Safety Communication in April 2013, and reported by Medscape Medical News at that time.

The agency is further recommending that patients undergo eye examinations by an ophthalmic professional prior to starting ezogabine, and every 6 months during treatment. “These exams should include visual acuity and dilated fundus photography, with additional vision testing as necessary,” the FDA statement notes. “Patients whose vision cannot be monitored should generally not take Potiga.”

It is not clear which patients are at risk for these retinal changes, how long it may take for them to be detected, the rate of progression, or their reversibility after treatment withdrawal, the advisory adds.

“If retinal pigmentary abnormalities or vision changes are detected, Potiga should be stopped unless no other suitable seizure treatment options are available and the benefits of treatment outweigh the potential risk of vision loss,” the statement said. “In addition, health care professionals should stop Potiga treatment in patients who do not show substantial clinical benefit after adequate dose titration.”

Patients are advised, though, not to stop taking the drug before consulting their healthcare provider.

The new label also includes warnings about the risk for discoloration of the skin, nail, mucous membrane, and white of the eye that were also outlined in the previous statement in April. If patients develop such discoloration, an alternate treatment should be considered, the new label advises.

All of these recommendations have been added to the label’s Warnings and Precautions section and the patient Medication Guide, which should be included with each prescription that is filled.

“FDA is working on modifying the current Risk Evaluation and Mitigation Strategy (REMS) for Potiga to address the risk of retinal pigmentary abnormalities, potential vision loss, and skin discoloration,” the statement concludes.

23 Seniors Have Died So Far This Year After Receiving Flu Shots.


Package insert for Fluzone flu vaccine marketed to seniors reveals 23 seniors died during drug trial

The annual marketing campaign pushing people to receive flu vaccinations is in full force. CVS Pharmacies is offering a 20% off shopping pass if you purchase a flu vaccine.

As you can see in the screen shot below, taken from the CVS website, senior citizens over the age of 65 are being targeted to get the “high-dose” flu vaccine.

The FAQ at the CVS website defines the “high-dose” flu vaccine: “Containing four times the amount of antigen (the part of the vaccine that causes the body to produce antibody) in regular flu shots, high-dose flu shots, along with the additional antigen produced, are intended to create a stronger immune response.”

The name of this flu vaccine that is marketed for seniors is called “Fluzone.” You can find it being marketed to seniors at all the major pharmacies in the United States.

Package inserts for flu vaccines show a multitude of side effects, including death, and yet they are marketed the same as over-the-counter drugs with no prescription needed. Why?

Because in the United States vaccines enjoy complete immunity from lawsuits in the market place. If you are injured or die from a vaccine, you or your family cannot sue the manufacturer of the vaccine. This law enacted by Congress, was upheld by the U.S. Supreme Court in 2011.

Therefore, they are marketed with the same marketing techniques as any other high-profit product. With the baby boomer generation moving into their senior years, today’s seniors are seen as an especially lucrative market.

So financial incentives like discounts on other products, as CVS is doing, is quite common in order to boost vaccine sales.

Walgreens has a different program that especially boosts sales of vaccines:

While vaccine rates in the U.S. among children are close to 90%, rates in other parts of the world (where pharmaceutical companies do not have immunity from the law for adverse effects) are much lower. So, in partnership with Walgreens, a non-profit organization (Shot@Life) buys up the vaccines and sends them to these countries for free (who doesn’t want something for free, especially when you live in a poor country??)

This is a brilliant marketing plan for the pharmaceutical companies, as the U.S. government gives the organization buying the vaccines non-profit status, allowing them to receive tax deductible donations to pay for the vaccines. Walgreens is probably a contributor to the program as a tax write off.

With legal immunity to market dangerous products, don’t expect those doing the marketing and making the profits to warn you of the side effects. You need to find this information yourself, usually from the Internet.

For those pro-vaccine forces that warn people how dangerous it is to get information from the Internet, the information we are about to share is directly from the FDA website (at least at the time of this writing – they have been known to remove items from their website if it gets too much publicity and makes them look bad), and you can look it up yourself.

The high-dose Fluzone vaccine being marketed this flu season to seniors, which has four times the amount of antigens that the regular flu shot has, as well as the non-high dose version, had 23 seniors die during drug trials.

In the section documenting adverse effects, this is what is written:

Within 6 months post-vaccination, 156 (6.1%) Fluzone High-Dose recipients and 93 (7.4%) Fluzone recipients experienced a serious adverse event. No deaths were reported within 28 days post-vaccination. A total of 23 deaths were reported during the period Day 29–180 post-vaccination: (0.6%) among Fluzone High-Dose recipients and 7 (0.6%) among Fluzone 1 recipients. The majority of these participants had a medical history of cardiac, hepatic, neoplastic, renal, and/or respiratory diseases. No deaths were considered to be caused by vaccination.

This statement stating that 23 seniors died, which really should be headline news but is buried in a package insert on the FDA website, begs several questions:

1. By what basis can they conclude that “No deaths were considered to be caused by vaccination”??

2. If, as it is implied, these 23 deaths were all caused by pre-existing conditions, why were there no deaths in the first 28 days? Shouldn’t the deaths, if not attributable to the vaccine but pre-existing conditions, be equally spread out through all time periods?
3. How does the medical history for these 23 seniors compare to the medical history of those who did not die? Were there any significant differences? The range of symptoms given in the package insert can very well cover almost all seniors during the flu season.

Besides death, which is just one “serious adverse event,” there were 226 other “serious” adverse events, for a total of 249 serious adverse events, out of only 3,833 participants.

If this does not constitute a dangerous drug that should probably not even be on the market, then I don’t know what does. And yet, it is sold to unsuspecting seniors and others like candy at these drug stores.

One of these other adverse side effects (besides death) is Guillain-Barré syndrome, which has symptoms similar to polio. If you are brought into an emergency room with the paralyzing effects of Guillain-Barré syndrome (GBS), the first question the doctors will ask you is if you just received the flu shot. Read one story here of how one man went from being able to bench-press 275 pounds to struggling how to walk after receiving last year’s flu shot: Miami Man Contracts Guillain-Barré Syndrome, Nearly Dies After Getting Flu Shot.

The CDC would like you to believe that the risk of GBS from the flu shot is only one out of one million. But if that is the case, why is there a warning on package inserts of flu vaccines, and why is it the first question EMTs ask when dealing with GBS emergencies?

The package insert for Fluzone states: “If Guillain-Barré syndrome (GBS) has occurred within 6 weeks of previous influenza vaccination, the decision to give Fluzone High-Dose should be based on careful consideration of the potential benefits and risks.”

I wonder how many vaccine sales people at these pharmacies give “careful consideration” to this adverse side effect, or any others, before injecting you?

 

Source: undergroundhealth.com