Finally a Canadian pharmaceutical company has received FDA approval to market Diclegis, a medication for treatment of morning sickness that has been commonly used in the U.S. for over 40 years. This is only newsworthy because finally a company has chosen to take on the risk of lawsuits that led to the removal of Bendectin from the market despite solid evidence of its safety in pregnancy. Who knows how many women or babies may have been harmed by trying and using poorly researched or untested remedies out of fear of this fairly effective and proven safe choice. It’s a sad state of affairs in our country when solid scientific evidence cannot trump emotion in courts when it comes to a trial by jury. I cannot find any evidence of settlements or awards to plaintifs not subsequently overthrown in appeals in lawsuits alleging fetal harm from Bendectin. Still the cost of defending these suits led to the removal of the drug from market as profits were not adequate to pay litigation expenses.
For my years in med school and residency training the use of the morning sickness pill Bendectin, a combination of vitamin B6, pyridoxine, and the antihistamine doxylamine was common practice. Then just as I finished residency training in 1983 Bendectin was withdrawn from the market. Although this combination drug has been more extensively studied than nearly every other drug in pregnancy and has been shown not to affect the incidence of birth defects or adverse outcomes of pregnancy it was withdrawn from the market by Merrill Dow Pharmaceuticals because of the high cost of defending against lawsuits. This led to use of many other antihistmines, antiemetics, and sedatives being used out of fear of using the easily available OTC componenets of Bendectin. It also has very likely led to many pregnant women requiring hospitalization and IV fluid support from dehydration. Certainly huge mistakes have been made in treatment of pregnant women with drugs that did lead to terrible problems, thalidamie comes immediately to mind. Still fear of litigation is the wrong reason to make medical decisions. We should rely on the best available evidence. Diclegis, a.k.a. Bendectin, has the best data of any available option for treatment of refractory morning sickness.
The combination of vitamin B6 50 mg combined with the over the counter sleep aide Unisom continued to be commonly used by women for management of morning sickness once Bendectin became unavailable. This off-label generically available option has been recommended by the American Congress of Obstetricians and Gynecologists (ACOG) for years as first line therapy for morning sickness refractory to non-pharmaceutical measures for years.
“Treatment of nausea and vomiting of pregnancy with vitamin B6 or vitamin B6 plus doxylamine is safe and effective and should be considered first-line pharmacotherapy” (1)
This week a Canadian pharmacy has applied for and gained U.S. FDA approval to market Diclegis. It will be interesting to see how commonly Diclegis is recommended to U.S. patients with morning sickness that is refractory to the usual recommendations to avoid fatty foods, to eat bland food like crackers before getting up in the morning, or whether other less well studied treatments continue to be used out of continued fear of litigation.