It’s been 30 years since there has been an FDA approved drug on the market designed to treat morning sickness in pregnant women, but that will change this summer. Sort of. In a recent decision, the FDA accepted the return of the drug to help pregnant women formerly known as Bendectin under the new name, Diclegis. Whatever you call it, all the components you need to make it are probably already in your medicine cabinet.
The treatment was pulled from shelves amid hundreds of lawsuits claiming the drug was causing birth defects. The FDA stood behind the drug and appeals courts ruled in favor of the pharmaceutical company making it, but Merrell Dow gave up the fight before it reached the US Supreme Court and quit making the product in 1983. Recent studies confirm the drug’s safety:
“We know safety-wise, there’s zero question,” said Dr. Gary Hankins of the University of Texas Medical Branch in Galveston, who headed one of the company-financed studies of Diclegis that led to its approval.
With little to no question that the birth defects of the previous lawsuits were unrelated, my guess is the mounting legal fees rendered the drug below desired profit margins. That’s where we can probably thank Kate Middleton. Her very public experience with hyperemesis gravidarum (HG) revived the industry and a Canadian-based manufacturer promptly got back in line to serve the U.S. some more.
Dr. Jeffrey Ecker, spokesman for the American College of Obstetricians and Gynecologists (ACOG), stressed that the “return of an FDA-cleared treatment is needed,” though it is unclear why.The pill is made of Vitamin B-6 combined with the antihistamine doxylamine, found in over-the-counter sleep aids. In recent decades, U.S baby doctors have been instructing pregnant women to whip some up at home rather than suffer with no FDA official drug. The ACOG went so far as to say the home remedy of over-the-counter materials should be considered “first-line therapy” for pregnancy sickness in 2004.
The midwife at my OB practice recommended the mixture when I suffered from severe pregnancy sickness with both of my children. It helped a little bit with my first pregnancy where I threw up only 3-5 times a day. For my second pregnancy, I was throwing up 10-12 times a day and the remedy didn’t even register. Those days my vomiting was triggered by even a sip of water. Zofran – a drug typically given to cancer patients – was the only thing that could curb my HG, but I had to take it and immediately go to sleep to keep it down, so I wondered what was the point? The drug was supposed to be helping me function and take care of my 18-month-old, but by the time I woke up the effects were mostly worn off. We lived at my parent’s house that summer.
Even if you don’t have an extreme case of pregnancy sickness, don’t expect any miracles.
“It’s not magic,” Ecker cautioned, saying few women see their symptoms completely disappear with the medication. “But for some it allows them to be much more functional.”
In [a] study, about 260 U.S. women with morning sickness were given either Diclegis or a dummy pill for two weeks. The Diclegis users missed on average 1 1/2 fewer days of work than their counterparts.
1.5 fewer absences from work? I’m not impressed. The manufacturer has not released the going price yet, but I’d guess the home-mixture will be just as effective. At least we have another stamp of approval that the concoction is safe during pregnancy.