Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Wednesday, June 5, 2013

Pregnant women, beware: Migraine medication might reduce your child's intelligence



As a general rule, pregnant women aren’t supposed to be taking in medications, as it is still not certain if these substances can affect the fetus that they are carrying. There have been many cases where some drugs and substances exhibited teratogenicity (a drug’s ability to cause fetal malformation), hence bringing it to become a matter of medical concern.



Image Source: pharmacytechnician.org


Adding to the long list of fetus-damaging drugs are anti-migraine medications Depakote and Depacon, both of which have been noted by the Food and Drug Administration for potentially causing mental retardation to children. This came after a study showing a pattern of reduced IQ scores among children whose mothers used the abovementioned drugs during pregnancy.

The culprit: a sodium salt called valproate sodium—originally an anticonvulsant which is also being used as a prophylaxis for migraines. Drugs containing this ingredient already come with FDA warnings that tell of its teratogenic effects. Apparently, some uninformed pregnant women would still take these drugs to ease the pain which is brought about the migraines.



Image Source: foxnews.com


When stuck in such quandary, mothers are advised to consider all the potential risks which might come from taking these drugs.

Dr. Russell Katz, FDA’s director for neurology drugs, recognizes the likely damage incurred by the medication. “We have even more data now that show the risks to the children outweigh any treatment benefits for this use,” he said. The FDA also said in a statement: “Women who can become pregnant should not use valproate unless it is essential to managing their medical condition.”



Image Source: bu.edu


There are many ways by which prospective mothers can keep their pregnancies healthy. Keep abreast with pregnancy-related updates by visiting this Facebook page for Dr. Cristian Andronic.

Tuesday, April 23, 2013

REPOST: Is the new morning sickness drug safe?

FDA has approved a drug with a combination of vitamin B6 and antihistamine to treat pregnancy-associated morning sickness. Is it really safe? This  article from Women's Health has the details. 


Image Source: blog.womenshealthmag.com
If Kate Middleton’s pregnancy has taught us anything, it’s that, for some women, morning sickness is way more than just a pregnancy-related annoyance. In fact, about one percent of pregnant women suffer from symptoms that are so severe, they actually require medical treatment. Luckily for these women, the FDA just approved a drug to treat morning sickness—the first in more than 30 years.

The drug, Diclegis, should be available by the end of May. While you may not have heard of it before, it’s actually far from new: Diclegis was sold in the U.S. more than 50 years ago under a different brand name, Bendectin. Bendectin was approved by the FDA in 1956 for the treatment of vomiting and nausea due to pregnancy. However, many women who took Bendectin ultimately filed lawsuits against the manufacturer, claiming that it caused birth defects. The FDA continued to maintain that Bendectin was completely safe, but the lawsuits persisted. Swamped by legal costs and bad press, the manufacturer stopped making the drug in 1983.

As scary as this all may sound, there is no clinical evidence to suggest that Diclegis can harm a fetus. In fact, Diclegis has been tested extensively in the intervening 30 years. Two meta-analyses of existing research have concluded that it’s safe for a growing baby. In 1999, the FDA announced publicly that the drug was not discontinued for safety reasons. Now, a Canadian manufacturer has stepped in, tested the drug under a new name, and received FDA approval.

Many doctors have welcomed the development with open arms. “It’s a very well-studied medicine,” says Jeffrey Ecker, MD, an obstetrician at Massachusetts General Hospital and a member of the American College of Obstetricians and Gynecologists. “The available information does not suggest a risk.” In fact, the ACOG has recommended the two main ingredients in Diclegis—pyridoxine hydrochloride and doxylamine succinate—as a treatment for morning sickness for the past nine years.

Bottom line: All signs indicate that Diclegis is safe. Still not sure if this pill is right for you? This info will help you decide.

What is it? 

Diclegis contains pyridoxine hydrochloride and doxylamine succinate. Pyridoxine is a form of vitamin B6, and doxylamine is an antihistamine (also found in certain allergy medicines). The tablets are delayed-release, so taking two at bedtime should help prevent the onset of morning sickness. If your symptoms are severe enough, you can take two more tablets throughout the day to keep your nausea in check. It’s not known why these ingredients work to reduce morning sickness, but in a recent study, it was found to be more effective than a placebo at reducing nausea and vomiting symptoms.

What are the possible side effects? 

Drowsiness is the main one. Like all antihistamines, doxylamine is known to make you sleepy. It’s best to avoid driving or operating heavy machinery while on the medicine.

How do you know if you should take it? 

If dietary and lifestyle changes aren’t working to ease your morning sickness, you may want to try taking vitamin B6 (one of the two ingredients in the drug) on its own. Ecker commonly prescribes 25 to 50 mg of B6, to be taken two to three times a day, to women with morning sickness. But if the B6 doesn’t help you, Diclegis may be your best bet.

“As with all medicines, folks that have had reactions to the ingredients shouldn’t take them,” says Ecker. If you know you have a B6 allergy or have reacted badly to anti-histamines in the past, skip this drug. For most people, though, these ingredients shouldn’t cause any problems—just easier mornings for moms-to-be.

Cristian Andronic, MD, FACOG, is one of the leading practitioners of gynecology in Milford, Delaware.Visit this Facebook page to know more about the industry.