New study finds morning sickness drug metoclopramide safe during pregnancy

Nausea and vomiting in early pregnancy, also known as morning sickness, is a common problem affecting up to 80% of pregnant women. For some, these symptoms are mild and respond to dietary changes. However, many women are severely impaired and intervention is needed. The problem? In the United States there is no drug approved for nausea and vomiting in early pregnancy because the safety bar is set very high. During the first trimester all the major organs and structures form.

The wrong drug can do a lot of damage in these few short weeks, a hard lesson learned in the 1950’s from thalidomide, a drug prescribed in Europe for morning sickness that caused horrific limb malformations.

A new study published this week in the New England Journal of Medicine sheds more light on the safety of metoclopramide (sold in the U.S. as Reglan) for treatment of nausea and vomiting in the first trimester of pregnancy. The study, performed in Israel, compared the incidence of birth defects among more than 3,400 infants exposed to metoclopramide in early pregnancy as compared with more than 77,000 infants not exposed to this drug. The results? Mothers who took metoclopramide for nausea and vomiting were no more likely to have a baby with a birth defect than women who did not take the drug.

This study did not look at the efficacy of metoclopramide nor side effects for the mother. Metoclopramide can cause severe muscle spasm in the head and neck in approximately 1 in 500 patients (it is very scary, but easily reversed with medication). Metoclopramide also carries a black box warning from the FDA because it can cause tardive dyskinesias, repetitive involuntary movements that can persist even after the drug is discontinued. This side effect is more common with prolonged use so the FDA recommends metoclopramide be taken for no more than three weeks.

In the U.S. there are currently no FDA approved drugs for morning sickness. Options include dietary changes (such as frequent small meals, crackers, bland food), ginger capsules, vitamin B6, and doxylamine (an over-the-counter drug sold as Unisom). Drugs that may be prescribed include prochlorperazine (Compazine), ondansetron (Zofran), and metoclopramide (Reglan).

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