Canadian Firm Hopes to Sell Morning Sickness Drug in U.S.
Oct. 10, 2000 -- After being unavailable for 17 years, a popular treatment for morning sickness may be making a comeback in the U.S. -- thanks in part to a Canadian drug company that has approached the FDA.
A recent survey showed that U.S. women have fewer options than Canadian women when it comes to managing the nausea and vomiting that often accompany pregnancy. This may be because Canadian, but not U.S., women have access to Bendectin, a drug that has been shown to be safe and effective at relieving their symptoms.
For about 80% of pregnant women, nausea and vomiting, especially in the morning and during the first three months of pregnancy, are an uncomfortable fact of life. "It is serious enough for about 10% of pregnant women to want a medication. ... About 1% have enough trouble that they need to come in the hospital to get intravenous fluids," says Jennifer Niebyl, MD, a professor and head of the department of obstetrics and gynecology at the University of Iowa in Iowa City.
Bendectin once offered relief to U.S. women, but it was withdrawn from the market in 1983 because of mounting lawsuits against its manufacturer, Merrell Dow, by women who took the drug during pregnancy and then gave birth to infants with birth defects.
But there is no good scientific evidence that taking Bendectin during pregnancy leads to birth defects. In fact, there's lots of evidence showing that it's quite safe for both mother and child. The same drug, under the name Diclectin, is used safely and effectively in Canada.
So why the lawsuits in the U.S.? Birth defects are an unavoidable part of life; some estimate that about 2.5% of babies are born with one or more. Some women who took Bendectin during pregnancy and then had a child with a birth defect assumed Bendectin was the culprit, and Merrell Dow chose to remove it from the market rather than face the growing number of lawsuits, despite the lack of evidence that its product was unsafe.
In the current scenario, Merrell Dow misses out on potential sales of a safe and effective product and American women are left without relief of morning sickness.
The new survey, which was conducted by Gideon Koren, MD, and colleagues at the Hospital for Sick Children and the University of Toronto, showed that Canadian women were more likely than U.S. women to be advised by their doctors to take a drug to treat their morning sickness. Furthermore, U.S. women suffered significantly more weight loss, hospitalizations, and time lost from paid work due to morning sickness than Canadian women.
That could change, now that the Canadian manufacturer of Diclectin, Duchesnay Inc., is petitioning the FDA to allow its product to be sold in the U.S. All the company has to do is show that its drug is identical to Bendectin, since Bendectin attained FDA approval years ago.
In the meantime, Niebyl has some advice for pregnant women suffering from morning sickness: "I try all the things that are [not drug-related] first: frequent small feedings to try to keep something in your stomach, [keeping] crackers at your bedside, avoiding smells that make you sick, taking a protein snack at bedtime.
"Then I try vitamin B-6 alone [which is a component of Bendectin]. After that, I combine it with Unisom, which is over-the-counter doxylamine [another component of Bendectin]. That helps most people."
Of course, pregnant women should never self-medicate. If you have morning sickness, talk to your doctor, who can safely tailor treatment to your specific needs.