Diclegis and Pregnancy
Diclegis (doxylamine and pyridoxine) is intended for use in women who are expecting, and does not appear to increase the risk for birth defects or other problems. Diclegis contains two active ingredients that have been studied and safely used for over 30 years in pregnant women. As a result, the FDA classifies this combination product as a pregnancy Category A medicine.
Diclegis® (doxylamine and pyridoxine) is a prescription medicine used to treat nausea and vomiting. It is intended for use in pregnant women and, when taken as directed, is safe for use during pregnancy.
The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Diclegis is classified as a pregnancy Category A medication.
Pregnancy Category A is given to medicines that have been extensively studied in pregnant women and do not appear to cause any harm to the fetus.
The combination of doxylamine and pyridoxine (the two active medicines in Diclegis) has been extensively evaluated in numerous studies that have looked at whether this combination is safe for use in pregnant women. These studies span a period of almost 30 years. None of the studies have shown an increased risk for birth defects or other problems when doxylamine and pyridoxine are used during the first trimester of pregnancy (the first three months).
Doxylamine and pyridoxine were the active ingredients in medications (in the United States and Canada) used to treat nausea and vomiting caused by pregnancy. A U.S. manufacturer of an older version of doxylamine and pyridoxine (previously sold under the name Bendectin) stopped making this drug after women reported that it caused defects of the limbs (the arms and legs) and had filed lawsuits. This particular drug was taken off the market in 1983. The Canadian products continued to be available.
Although Diclegis contains the same active ingredients as Bendectin, it was approved by the FDA in April 2013. Research has shown that the combination of doxylamine and pyridoxine has been used safely by more than 30 million pregnant women worldwide.
The widespread use of doxylamine and pyridoxine, without an apparent increased risk for birth defects, supports the assertion that Diclegis is safe for use by pregnant women. Based on the available evidence, the medication does not appear to increase the risk for birth defects, and the original reports of possible limb defects from the combination of doxylamine and pyridoxine do not appear to be founded.
Very few medications are given the classification of pregnancy Category A. Therefore, if the FDA classifies a medication as Category A, it is an excellent indication that the medication is safe for use during pregnancy.