FDA anesthesia warning for pregnant women and young children: possible brain development risk.

Repeated or lengthy use — longer than three hours — of general anesthetic and sedation drugs may harm the developing brains of fetuses and children younger than 3 years old, the U.S. Food and Drug Administration warned Wednesday.

After reviewing the latest published studies, the agency announced that these warnings need to be added to the labels of these drugs.

The agency also issued a Drug Safety Communication to inform health care providers, parents and caregivers of the potential danger.

“We recognize that in many cases these exposures may be medically necessary, and these new data regarding the potential harms must be carefully weighed against the risk of not performing a specific medical procedure,” Dr. Janet Woodcock said in an agency news release. She is director of the FDA’s Center for Drug Evaluation and Research.

“Parents and caregivers are often concerned when their young child requires a medical procedure for which anesthesia or sedation drugs are necessary. Understandably, there are many questions, including whether the drugs are safe for their child,” she said.

Pregnant women who must undergo medical procedures that require anesthesia or sedation drugs have similar concerns,” Woodcock added.

In 2010, the FDA formed a partnership with the International Anesthesia Research Society to fund research to learn more about the use of these drugs in young children and pregnant women.

“We hope that this information helps enable the most informed medical decisions possible about the use of anesthesia in young children and pregnant women,” Woodcock said.

“We will continue to work collaboratively to leverage our collective resources to address this important issue, and we will update the public with additional information, as it becomes available,” she said.

Pregnant women to serve as human guinea pigs for experimental Zika vaccine.

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‘Researchers from MIT (Massachusetts Institute of Technology) have developed a brand new vaccine – in just seven days, believe it or not – that they claim is capable of treating everything from Ebola and H1N1 influenza, to the newest villain on the block: the Zika virus that’s on everyone’s minds as the 2016 Summer Olympics in mosquito-ridden Rio De Janeiro, Brazil, rapidly approaches.

Omar Khan, a chemical engineer who helped conduct research into the new vaccine, says it uses messenger RNA, or mRNA, to provoke an immune response in the body. mRNA is a special type of genetic material that’s responsible for manufacturing proteins in cells, which can be customized and coded to target a variety of illnesses. And according to experts, it’s already been shown to have a 100 percent success rate in mice.’

Zika RNA Detectable in Pregnant Women After 2 Weeks

Zika virus RNA was detected in the blood of five pregnant women who had been exposed to the virus at least 2 weeks prior to PCR testing, case reports from the CDC’s U.S. Zika Pregnancy Registry showed.

This adds to the evidence that Zika virus may be detectable in pregnant women for longer than previously thought, reported Dana Meaney-Delman, MD, of the CDC, and colleagues.

 The CDC recently updated their guidance to providers treating pregnant women to expand the window where real-time PCR testing can be used — from 7 days to up to 14 days following exposure, and these results seem to support these new recommendations.

Writing in a special fast-tracked study in Obstetrics and Gynecology, the authors examined five pregnant women who had traveled to or lived in countries with active Zika virus transmission — four of whom were symptomatic, while one was asymptomatic. Zika virus RNA was detected via real-time RT-PCR in the serum of the four symptomatic pregnant women from a range of 17 to 46 days following exposure, and in the asymptomatic woman 53 days after exposure.

One symptomatic woman had evidence of Zika infection in the fetal tissue, and opted for pregnancy termination. Similar to prior fetal autopsies, Zika virus RNA was discovered in the skeletal, muscle, bone, and placenta, but not the umbilical cord, liver or lung tissue.

Two symptomatic and one asymptomatic woman went on to deliver healthy infants, while one symptomatic woman has an ongoing pregnancy. However, new researchindicates that it is possible that the effects of congenital Zika virus infection may not manifest until later in a child’s life.

With these new cases, there have now been a total of eight pregnant women with evidence of Zika virus detected in their blood for a prolonged exposure. These data seem to confirm animal studies that have discovered similar results when comparing pregnant subjects compared to non-pregnant subjects. Meaney-Delman and colleagues noted that other infectious diseases associated with adverse pregnancy outcomes, such as hepatitis E, follow similar patterns.

“Delayed immune clearance of viruses from the maternal circulation may reflect altered immunity during pregnancy,” they wrote. “Alternately, fetal infection and ongoing viral replication in the fetus or placenta might result in the transfer of viral genetic material into the maternal circulation.”

Further research is needed in a larger population of women to determine whether or not pregnancy status impacts how long Zika virus RNA stays in a patient’s blood. If confirmed, the CDC has the potential to expand their real-time RT-PCR assay, the Tripolex test — which detects Zika virus RNA in serum and cerebrospinal fluid, and can be used for urine and amniotic fluid, as well. This test also rules out similar flaviviruses, dengue and chikungunya.

“Expanding real-time RT-PCR testing may provide additional diagnostic information and increase the proportion of pregnant women with Zika virus infection who receive a definitive diagnosis,” the authors conclude. “[This] may improve our understanding of the diagnostic, epidemiologic and clinical implications of prolonged detection of Zika virus RNA during pregnancy.”

Pregnant Women May Overestimate Risk of Some Drugs

Pregnant women are often steering clear of drugs that might ease problems like nausea and urinary tract infections even though the treatments may be safe, a U.K. study suggests.

Researchers surveyed 1,120 women about common problems they experienced during pregnancy and whether they thought medications to treat these issues were harmful or beneficial.

Overall, about 76 percent of the women reported taking medication for at least one of eight common conditions during pregnancy including nausea, heartburn, constipation, colds, urinary tract infections, neck or pelvic pain, headaches and sleeping problems.

But for some problems, many women didn’t take medications, even when drugs might not be harmful or forgoing treatment might be dangerous, researchers report in the International Journal of Clinical Pharmacy, online May 30.

“Many women avoid medications as they fear harming the child,” said lead study author Michael Twigg, a pharmacy researcher at the University of East Anglia.

“We don’t want women to avoid medication and suffer unnecessarily from conditions that can be treated relatively easily,” Twigg added by email.

To understand how women think about medication use during pregnancy, Twigg and colleagues analyzed data from an online survey of women in England, Scotland, Wales and Northern Ireland.

Roughly 40 percent of the participants were pregnant when they completed the survey, while the rest had given birth within the previous year.

About 17 percent of the women reported having a chronic medical condition, most often asthma, allergies, depression, anxiety or thyroid issues.

For common pregnancy issues like nausea, sleep problems and constipation, women often avoided medication even though there are certain treatments available that are not considered harmful, the study found.

Even though about 79 percent of women experienced nausea during pregnancy, for example, only around 10 percent of them took medication.

Non-prescription anti-nausea drugs offer an example of how women may needlessly suffer and potentially allow small problems to escalate into bigger ones by avoiding treatment, said Angela Lupattelli, a study coauthor and pharmacy researcher at the University of Oslo in Norway.
“Nausea and vomiting can be very devastating for women, and it is very important that women do not become dehydrated or unhealthy as a result of pregnancy sickness,” Lupattelli added by email.

With sleep, 67 percent of women reported problems but only about 1 percent of them took drugs even though there are some nonprescription options that are not considered harmful during pregnancy.

Roughly 55 percent of women said they suffered from constipation, but only 19 percent of them turned to medication for relief. In this case, too, certain medications are thought to be safe during pregnancy.

Most worrisome, only about 65 percent of women who developed urinary tract infections during pregnancy took medications, a concern because these can escalate into kidney infections that can be life threatening for both mothers and their babies.

“Some untreated conditions such as urinary tract infections mentioned in the article, but also chronic conditions including depression, may cause severe complications, endangering the health of the mother and her unborn child,” said Marleen van Gelder, a pharmacy researcher at Radboud University Medical Center in the Netherlands who wasn’t involved in the study.

One problem, of course, is that drug trials exclude pregnant women for ethical reasons, limiting how much we know about whether many treatments are truly safe during pregnancy, van Gelder added by email.

Safety can also vary by trimester, and the benefits and harms of treatment may depend on the severity of women’s symptoms and other aspects of their pregnancy or medical history, ven Gelder noted.

One limitation of an online study is that the subset of women who choose to participate may not reflect the broader population, the authors note. The study team also lacked participants’ medical records or data on their drug use during pregnancy to assess how the severity of certain conditions might have influenced the women’s opinions about medication.

Women should ask a health professional when they have questions about drugs during pregnancy, Twigg advised.

“The consequences of not discussing appropriate use of medicines during pregnancy . . . can be serious,” Twigg said.

Nearly Half of Pregnant Women Who Give Up Smoking Pick it Up Again, Study Shows

Study shows 43% of women who quit smoking during pregnancy pick the habit back up six months after birth

Data suggests the majority of women who smoke try to quit if they find out they’re pregnant, but it’s unclear whether they keep it up after they’ve given birth. A new study adds to the evidence, showing that nearly half of women who kick the habit while pregnant will become smokers once again.

The new report, published Tuesday in the journal Addiction, looked at 27 different trials that attempted to help pregnant women quit smoking. The researchers took a closer look at whether these women stayed non-smokers six months after giving birth. They found that among the women who were offered some sort of smoking cessation intervention, 13% were able to quit sometime during the pregnancy and remain abstinent when they delivered. The other 87% of women either tried to quit and were not able to do so, or they did not attempt to kick the habit. Of the 13% that did quit, the researchers found that 43% started smoking again by six months.

“Most pregnant smokers do not achieve abstinence from smoking while they are pregnant, and among those that do, most will re-start smoking within 6 months of childbirth,” the study authors write. “This would suggest that despite large amounts of health-care expenditure on smoking cessation, few women and their offspring gain the maximum benefits of cessation.”

Data from the U.S. Centers for Disease Control and Prevention (CDC) suggests that around 10% of women reported smoking during the last 3 months of pregnancy. And even among women who attempt to quit, keeping it up over the long term remains difficult, the new findings suggest. The study authors argue more needs to be done to find better ways to help mothers stop smoking for good.

Number of pregnant women with Zika infections increases

The Centers for Disease Control and Prevention is reporting nine additional Zika infections in pregnant women.

Eighteen cases of Zika have been diagnosed in pregnant U.S. women, up from the nine that the CDC has previously reported in detail.

Eight of the 18 women are still pregnant, while 10 have either delivered their babies or had abortions or miscarriages, according to the CDC.

All of the  women had traveled to an area with a Zika outbreak, according to the CDC. Zika virus is not yet spreading in the continental USA. At least 258 U.S. travelers have been infected with Zika while visiting the Caribbean or South America.

Zika is spreading widely in Puerto Rico and other U.S. territories, which are reporting three travel-related cases and 283 cases spread by local mosquitoes, including 35 in pregnant women. Zika is spread by the Aedes aegypti mosquito.

The CDC has started a pregnancy registry to learn more about Zika-affected cases.

The CDC has reported details for the first nine of the pregnancies: one woman gave birth to a baby with microcephaly, a condition in which babies are born with abnormally small heads and incomplete brain development; two miscarried; two had abortions; two gave birth to healthy babies and two are still pregnant.

The number of Zika-affected countries with microcephaly cases is growing.

Doctors have diagnosed microcephaly in Cape Verde, an island off the coast of Africa that has been battling a Zika virus epidemic.

Researchers are investigating the case to see if it’s related to Cape Verde’s Zika infection, according to the World Health Organization.

Brazil, which normally had about 150 cases of microcephaly a year, has confirmed 863 cases of the condition in recent months, said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. Brazil is investigating an additional 4,268 suspected cases of microcephaly. A handful of cases of microcephaly also have been diagnosed in Colombia, which also has a large Zika outbreak, he said.

There have been 7,490 suspected cases of Zika virus in Cape Verde between Oct. 21 and March 6, according to the WHO. About 165 of the cases involve pregnant women; 44 of these women have delivered without any complications or abnormalities.

In related news, the Food and Drug Administration issued an emergency approval for a new three-in-one test for Zika, dengue and chikungunya viruses, which are all spread by the Aedes mosquito. The CDC hopes the new test will save time, because doctors will be able to test for all three viruses at once, instead of running three separate tests. The test uses a polymerase chain reaction (PCR) technique to detect genetic material from the viruses in blood. Because the Zika virus only stays in the blood for about a week, the test will only produce positive results during that time.

The CDC will begin sending to 150 labs around the USA on Monday, and also send the tests to countries and territories with Zika outbreaks.

General Surgery Safe for Pregnant Women, Study Shows

Compared with women who are not pregnant, those who are pregnant have no significant difference in postoperative complications after general surgery, according to a retrospective cohort study published online May 13 in JAMA Surgery.

“Pregnancy is associated with physiologic changes in body habitus and the coagulation, cardiovascular, pulmonary, and immune systems,” write Hunter B. Moore, MD, from the Department of Surgery, School of Medicine, University of Colorado, Aurora, and colleagues. “These changes pose a diagnostic and treatment challenge to surgeons because physical examination findings and laboratory test values are different from those routinely encountered. Therefore, it might be expected that postoperative complications in pregnant patients are increased compared with those in nonpregnant patients.”
Approximately 1 in 500 pregnant women require nonobstetric surgery. Findings from previous research comparing the occurrence of adverse outcomes after such surgery in pregnant vs nonpregnant women have been conflicting. The investigators suggest this may be because of insufficient adjustment for differences between pregnant and nonpregnant women, and they used propensity matching to overcome this obstacle.

Using the American College of Surgeons’ National Surgical Quality Improvement Program participant user file from January 1, 2006, to December 31, 2011, the investigators identified pregnant surgical patients and matched them, on the basis of 63 preoperative characteristics, with nonpregnant women undergoing the same operations by general surgeons.

Before matching, the patient pool included 2764 pregnant women, of whom 50.5% had emergency general surgery, and 516,705 nonpregnant women, of whom 13.2% had emergency general surgery. Compared with nonpregnant women, pregnant women were more likely to have surgery in an inpatient setting (75.0% vs 59.7%). They were also younger, with fewer comorbidities but more abnormal laboratory test results.

Using propensity matching, the investigators identified 2539 pregnant and 2539 nonpregnant women with no meaningful differences in preoperative characteristics.

At 30 days, pregnant women and nonpregnant women had similar rates of mortality (0.4% vs 0.3%, respectively; P = .82), overall morbidity (6.6% vs 7.4%; P = .30), and 21 individual postoperative complications.

Limitations of this study include observational design, which precludes determination of causality and lack of data on fetal outcomes.

“We did not account for fetal complications in this study and would not advocate that our findings be generalized to elective surgical situations that can be postponed until after delivery,” the study authors write. “These findings support previous reports that pregnant patients who present with acute surgical diseases should undergo the procedure if delay in definitive care will lead to progression of disease.”

Paracetamol may harm unborn boys’ fertility, pregnant women warned .

Scientists say study adds to existing evidence that too much paracetamol in pregnancy may increase risk of reproductive disorders in male babies

Paracetamol risk for unborn boys

Prolonged paracetamol use by pregnant women may reduce testosterone production in their unborn sons, research has found.

Scientists at the University of Edinburgh said their study adds to existing evidence that too much paracetamol in pregnancy may increase the risk of reproductive disorders in male babies.

They said expectant mothers should follow existing guidelines that the painkiller be taken at the lowest effective dose for the shortest possible time.

Research carried out on mice found that rodents given three doses of paracetamol a day for a week had a 45 per cent reduction in testosterone compared to a placebo.

The hormone, which is produced in the testicles, is crucial for life-long male health. Reduced exposure to testosterone in the womb has been linked to an increased risk of infertility, testicular cancer and undescended testicles.

Paracetamol ‘fails to ease low back pain’
NHS spends £80m a year on paracetamol prescriptions

The study saw scientists test the effect of paracetamol on mice carrying grafts of human testicular tissue, which have been shown to mimic how the developing testes grow and function during pregnancy.

They gave the mice a typical three-times daily dose of paracetamol over a period of either 24 hours or seven days, and measured the amount of testosterone produced by the human tissue an hour after the final dose of paracetamol.

They found there was no effect on testosterone production following 24 hours of paracetamol treatment, but after a week of exposure the amount of testosterone was reduced by 45 per cent.

Current NHS guidance on paracetamol use during pregnancy advises that, as with any medicine, it should be taken at the lowest effective dose for the shortest possible time.

Dr Rod Mitchell, of the University of Edinburgh, said: “This study adds to existing evidence that prolonged use of paracetamol in pregnancy may increase the risk of reproductive disorders in male babies.

“We would advise that pregnant women should follow current guidance that the painkiller be taken at the lowest effective dose for the shortest possible time.”

The Royal College of Midwives’ head of education, Carmel Lloyd, said: “If women do take medicines such as paracetamol when they are pregnant, they should use the lowest effective dose for the shortest possible time. If the recommended dose doesn’t control their symptoms or they are often in pain, they should seek more advice from their midwife or doctor.

“Ideally, women should avoid taking medicines when they are pregnant, particularly during the first three months. Minor conditions such as colds or minor aches and pains often do not need treating with medicines. If women feel they need to take medicines such as paracetamol when they are pregnant, they should talk to their midwife or doctor first; they can also get advice from their local pharmacy.”

Dr Martin Ward-Platt, of the Royal College of Paediatrics and Child Health, said: “The findings of this study send a clear message – expectant mothers should not prolong paracetamol use during pregnancy, only taking it when necessary and as per current NICE guidelines.

“However, the study specifically relates to paracetamol use over at least several days. There are times where one or two doses is needed to treat one-off episodes of fever for example. Fever during pregnancy can be harmful to the developing embryo, with links to a significant increase in the rates of spina bifida and heart malformations, so small doses of paracetamol are sometimes necessary.

“My message to expectant mothers is clear – avoid over-use of paracetamol but if you do have a fever, or any other sort of pain where you would normally use paracetamol, seek medical advice.”


Pregnancy and dialysis.

Survey results suggest lack of clear guidelines leads to uncertainty.

  • Medpage Today

A third of nephrologists reported being somewhat to very uncomfortable caring for a pregnant patient on hemodialysis despite a growing number having to do so, said researchers here.

A small mailed survey found that 43% of nephrologist respondents have cared for a pregnant patient on dialysis, and in 32% of those pregnancies, dialysis was started during the pregnancy. Half of all the pregnancies were complicated by preeclampsia, and 23% of the reported pregnancies did not result in a live birth, said researchers, led by Mala Sachdeva, MD, at the North Shore-Long Island Jewish (LIJ) Health System in Great Neck, N.Y. She reported her results with her colleagues at a poster session during the spring clinical meeting of the National Kidney Foundation.

“We had actually noticed that we were caring for more and more pregnant patients on dialysis, and we had a couple of successful pregnancies and we wanted to see what the U.S. experience was,” said Sachdeva in an interview with MedPage Today. But she said the team was surprised by the outcomes. “They were not great, though there were no reported maternal deaths. It tells us that we need something to work on,” she said.

Data were taken from a survey sent out in May 2014 with 23 questions about the experience of pregnant women on dialysis, fetal outcomes, and current clinical patterns associated with pregnant patients on dialysis. Seventy-five nephrologists responded.

More than 59 pregnancies were reported in the last 5 years, and in 32% of the reported pregnancies, dialysis was started during pregnancy. In 58%, the pregnancy occurred within the first 5 years of being on maintenance dialysis.

Half of the nephrologists or a member of their staff had to counsel a female dialysis patient about contraception, the study found. And three-quarters of respondents didn’t have access to fetal monitoring during dialysis for the patient.

Most of the nephrologists had their pregnant patients on 4 to 4.5 hours of hemodialysis for 6 days a week, and two-thirds of nephrologists targeted a blood urea nitrogen (BUN) of less than 50mg/dL. But there are no clear guidelines on how to dialyze a pregnant women, said Eileen Miller, MD, medical director of dialysis at North Shore-LIJ, toMedPage Today.

The lack of guidelines accounts for a part of why many nephrologists reported being uncomfortable dialyzing a pregnant patient said Miller. Another reason is that pregnant women on dialysis were relatively uncommon. “But as dialysis has gotten better, we’re seeing more of it, and we need better guidelines so people will feel more comfortable. The last studies done looking at pregnant patients were more than 15 years ago,” she said.

STD Symptoms In Women Are Less Obvious And So Less Treated, Could Lead To Infertility

The reasons women are impacted by STDs more than men include the fragility of the vagina and the fact that her symptoms are less obvious. 

When it comes to unprotected sex, women naturally bear more of the consequences than men. Certainly, a man will never become pregnant after sex without a condom, but a woman also might bear, disproportionately, the consequences of sexually-transmitted diseases (STDs). Consider a few sobering facts: untreated STDs cause infertility in at least 24,000 women each year in the U.S. alone. You may be astonished to learn as well that untreated syphilis in pregnant women causes infant death in up to 40 percent of all cases. Finally, when it comes to untreated chlamydia, men suffer neither symptoms nor ill effects most of the time, while women can develop pelvic inflammatory disease which might lead to reproductive system damage.

So why are women impacted by STDs differently than men? A few key reasons go a long way to explaining feminine vulnerability:

One/ For many common STDs — including chlamydia and gonorrhea — women are less likely to show symptoms compared to men and when symptoms do occur, they may appear to go away even though the infection remains. More importantly, men find it easier to notice symptoms because they signs are so obvious — an unusual discharge, for example. Since women experience a whole range of natural discharges, all of them quite normal, they find it much more difficult to distinguish when an abnormal one appears.

Two/ Not only is the vagina a suitably moist environment where bacteria may easily flourish, but its lining is exceedingly more delicate and thinner than the skin of a penis. This natural fragility means viruses find it easier to penetrate.

Three/ Women have visibility issues. Notably, it’s harder for a woman to see a genital ulcer (from syphilis, say, or herpes) because they could occur only inside her vagina and not on the surface of her genitalia. Meanwhile, it’s difficult for a man to miss seeing a sore making its debut on his penis.

Four/ Finally, everyday sexually transmitted infections wreak havoc on a woman’s more gentle system while causing no problems in men. Along with chlamydia, the human papillomavirus (HPV) is contracted by both men and women frequently. However this common virus does not lead to serious (if any) health problems for most men while it is the main cause of cervical cancer in women. The fairer sex has been dealt an unequal hand.

So what’s a woman to do? In a phrase: protect yourself.

Speak Up

See your doctor, but more importantly talk to your doctor. There’s no shame in asking to be tested for sexually transmitted infections and diseases, and this is true whether your visit is with your primary care physician or your ob/gyn. If you haven’t already been given one, you might want to ask for the HPV vaccine.

Don’t stop here, though. Once you get a sense of a partner’s sexual history, go all the way and ask about STDs, especially if he or she has been around the block a few times. Make it a joke, if you have to, but simply ask: Ever been tested for STDs?

Finally, and yes we’ve saved the best for last, use condoms. Imperfect though they may be, they offer a good deal of protection against STIs and pregnancy. You’re never perfectly safe, and sadly, even long-term boyfriends (and husbands) have been known to spread disease to their partners. It’s always worth it, knowing you’ve done your best at self-protection.

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