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.
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| 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.
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