Pyridoxine/doxylamine - Society and Culture

Society and Culture

The Bendectin case, and the subsequent removal of the drug from the US market, has had a number of consequences. Firstly, there was an immediate increase in the rates of hospitalization for nausea and vomiting in pregnancy. Secondly, to-date a safe medication that alleviates morning sickness in pregnant women - not a trivial matter as the most severe form of nausea and vomiting of pregnancy, called hyperemesis gravidarum can be life-threatening or cause women to terminate their pregnancy - is not available in the US. The lack of availability of a safe and effective drug for the treatment of nauseas and vomiting of pregnancy has resulted in the use of other, less studied drugs in pregnancy. Thirdly, it has been claimed that subsequent to the Bendectin experience drug companies stayed away from developing medications for pregnant patients. As a result only two medications (oxytocin, cervidil) were approved between 1962 and 2010 for obstetrical indications by the FDA. Lastly, the perception that all medications are teratogenic increased among pregnant women and healthcare professionals. The unfounded fear of using medications during pregnancy has orphaned many women from receiving the appropriate treatment they require. Leaving medical conditions untreated during pregnancy can result in adverse pregnancy outcomes or significant morbidity for both the mother and baby. Ongoing education of physicians and the general public has resulted in improvements in the perception of medication use in pregnancy; however, further advances are required to overcome the devastating effects of the Bendectin saga.

From a legal perspective, the case through Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993) set a new standard for admitting expert testimony in federal courts in lieu of the Frye standard. 8