From the Guidelines
Bendectin, a medication that was previously used to treat nausea and vomiting in pregnancy, is no longer available in the United States, but its equivalent, Diclegis, is considered safe and effective for managing this common pregnancy complication. The medication contained a combination of doxylamine succinate (an antihistamine) and pyridoxine hydrochloride (vitamin B6) 1. It was voluntarily withdrawn from the U.S. market in 1983 due to numerous lawsuits alleging birth defects, despite the fact that scientific evidence did not support these claims. Some key points to consider when treating nausea and vomiting in pregnancy include:
- Early treatment of nausea and vomiting of pregnancy may reduce progression to hyperemesis gravidarum 1
- Stepwise treatment consists of symptom control with vitamin B6 and doxylamine, hydration, and adequate nutrition 1
- Ondansetron, metoclopramide, promethazine, and intravenous glucocorticoids may be required in moderate to severe cases 1
- Anti-emetic agents with favorable pregnancy safety include ondansetron 1 Today, a similar formulation called Diclegis is available in the U.S. by prescription, containing the same active ingredients (10 mg doxylamine and 10 mg pyridoxine). For women experiencing pregnancy-related nausea and vomiting today, this modern equivalent is considered safe and effective. The controversy surrounding Bendectin represents a case where legal pressures, rather than scientific evidence, led to the removal of a medication that was actually beneficial for managing a common pregnancy complication.
From the Research
Old Medicine for Vomiting in Pregnancy
- The old medicine for vomiting in pregnancy that is not available anymore is Bendectin, which was a combination of doxylamine succinate and pyridoxine hydrochloride 2.
- Bendectin was withdrawn from the U.S. market due to concerns about its possible teratogenicity, although the risk was found to be minimal 2.
- The same active ingredients, doxylamine and pyridoxine, were later reintroduced into the American market in the form of Diclegis, which is currently the only FDA-approved medication for the treatment of nausea and vomiting in pregnancy 3.
- Diclegis has been shown to be safe and effective for the treatment of nausea and vomiting in pregnancy, with a substantial amount of safety data accumulated over the years 3, 4.