Recently the FDA announced that the drug Diclegis – formerly known as Bendectin – would soon be returning to the market. It was pulled off the market 30 years ago after hundreds of lawsuits were filed claiming the drug caused birth defects in children. Designed to treat women suffering from morning sickness, Diclegis is set to become available again in June.
The history of Bendectin
Bendectin hit the market in 1956 and an estimated 33 million women worldwide were prescribed the drug. However, once the lawsuits began, Merrell Dow, the original distributor, found the cost of defending the drug prohibitive and discontinued it in 1983. According to the New York Times, Bendectin is the only drug withdrawn from the market solely because of litigation. The litigation eventually made legal history when, in 1993, the Supreme Court ruled on the matter, concluding that judges are to act as gatekeepers and ensure that ''any and all scientific testimony or evidence admitted is not only relevant, but reliable. ''Lawyers representing women who said the drug had damaged their children brought experts into court who, critics said, were not qualified to comment on the drug. Studies eventually concluded that Bendectin didn't increase the baseline risk for birth defects, which is one in 33 babies, according to the Centers for Disease Control and Prevention.
What’s in Bendectin/Diclegis?
The main ingredients in the drug are a combination of Vitamin B6 (pyridoxine) and an over-the-counter antihistamine, doxylamine. Even after the drug was pulled from the market in the U.S. (the drug continued selling in Canada under the name Diclectin), American obstetricians continued to recommend that nauseated pregnant women mix a similar concoctions for themselves. In 2004 the American College of Obstetricians and Gynecologists issued guidelines calling the combination a first-line therapy. The only difference between the combinations mixed by women themselves and the prescription-only Diclegis was a delayed-release coating designed to help women take a daily dose before their nausea sets in. Also, Diclegis is chemically the same as it was as Bendectin, hence its easy re-introduction into the FDA approval process.
What caused the original hysteria?
ABC News contends that part of the reason for the hysteria surrounding Bendectin was because of what had happened with the drug thalidomide, a medication marketed as a sleeping pill safe even for pregnant women. Thalidomide was found to cause birth defects and, before its removal from the marketplace in 1962, thousands of mothers who took the drug gave birth to babies with malformed limbs. As a result, women were quicker to blame medications taken during pregnancy for complications and birth defects.
The bottom line
Experts say that the “new” drug, Diclegis, is possibly one of the most widely tested drugs on pregnancy of all time and has shown no causal relationship between the drug and birth defects. On the other hand, it’s impossible to say with certainty that there won’t be the possibility of any negative side effects.
Doctors advise trying other steps before turning to medication for morning sickness, including eating protein snacks before bed, nibbling crackers or sipping ginger ale before getting out of bed, and eating frequent small meals throughout the day. About three-quarters of women experience at least some nausea and vomiting during pregnancy, and about 1 percent experience severe vomiting called hyperemesis gravidarum, the condition that put Kate Middleton in the hospital last December. The potential pros and cons should be weighed carefully, and for some pregnant women who suffer from constant vomiting and danger of dehydration, this medication will probably come as a relief.
Huffington Post. (08 April, 2013). “FDA Approves Return of Drug For Morning Sickness.” Found at http://www.huffingtonpost.com/2013/04/09/fda-approves-return-of-dr_0_n_3041856.html
ABC News. (09 April, 2013). “FDA Approves Morning Sickness Drug Once Feared Unsafe.” Found at http://abcnews.go.com/Health/fda-approves-morning-sickness-pill-pulled-market/story?id=18914496&singlePage=true#.UWbLG6LOlR0
The New York Times. (26 September, 2000). “Controversial Drug Makes a Comeback.” Found at http://www.nytimes.com/2000/09/26/science/controversial-drug-makes-a-comeback.html?pagewanted=all&src=pm
Published On: April 15, 2013