FDA approves once-popular morning sickness drug


Since NVP usually improves after the first trimester, "health care professionals should reassess their patients for continued need for Diclegis as pregnancy progresses," the FDA statement says. In addition, women should not use Diclegis "when engaging in activities requiring mental alertness, such as driving or operating heavy machinery, until cleared to do so by their health care provider."

The label states that Diclegis has not been studied in women with hyperemesis gravidarum and that women should not breastfeed while on the drug.

Dr. Koren has served as a consultant for Duschesnay.

The prescribing information for Diclegis is available here. Adverse events associated with this product should be reported to the FDA’s MedWatch program or by calling 800-332-1088.

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