Where are the epidemiologic studies published showing no harm to the fetus ? As mentioned by the FDA.
Morning-Sickness Pill Bendectin Back on the Market with a New Name — Physician’s First Watch
Morning-Sickness Pill Bendectin Back on the Market with a New Name
By Amy Orciari Herman
The combination of doxylamine succinate and pyridoxine hydrochloride has once again been approved to treat nausea and vomiting in pregnancy, the FDA has announced. The drug, to be marketed as Diclegis, was previously sold under the name Bendectin.
Bendectin was voluntarily pulled from the market in 1983 over concerns about birth defects; those concerns later proved to be unfounded.
The new approval was based on a randomized trial in which Diclegis outperformed placebo among some 260 pregnant women. In addition, says the FDA, epidemiologic studies show that the drug does not harm the fetus.
Severe sleepiness can occur with Diclegis, so patients should not drive, operate heavy machinery, or perform other activities that require mental alertness while taking the drug.
Clinicians should reassess a patient's continued need for Diclegis as the pregnancy progresses, the FDA advises.