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).

Source : www.examiner.com

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Study finds little risk from a morning sickness medication

As many as 80% of pregnant women suffer morning sickness in the first trimester of pregnancy. For the lucky ones, it can be controlled with saltines and frequent small meals. When such strategies do not work, physicians often prescribe drugs to control the nausea -- even though none are approved for such use in the U.S.

Now, in the first study of any of these medications in pregnant women, one has been found unlikely to affect the health of the fetus.


The drug, metoclopramide -- sold generically and under the brand names Reglan, Octamide and Maxolon -- is occasionally used for more severe cases in this country. It is used more commonly in Europe and Israel, although there has previously been little information about its safety. The drug speeds emptying of the stomach and reduces heartburn.

In this country, the medications Compazine, Phenergan and Zofran are the most frequently prescribed for morning sickness.

Two other drugs once used for morning sickness were pulled from the market over serious concerns, leading many women and doctors to fear any anti-nausea medication. Thalidomide, used in Europe and Canada in the late 1950s and 1960s but never approved in the U.S., caused missing or shortened limbs. Bendectin was withdrawn from the market in 1983 after lawsuits alleging similar problems.


"Most times, we try to avoid using drugs, period," said Dr. James Moran, chairman of obstetrics and gynecology at St. John's Health Center in Santa Monica. He said that he thinks the new findings should be replicated but that he "wouldn't hesitate to use Reglan at all."

In the new study, a team led by Ilan Matok of Ben-Gurion University of the Negev in Beersheba, Israel, studied 81,703 births among women enrolled in Israel's largest health maintenance organization; 3,458 of the women used metoclopramide during their pregnancies.

Matok and colleagues report in today's New England Journal of Medicine that there were no statistically significant differences between those who took metoclopramide and those who did not.

The findings, researchers said, "provide reassurance regarding the safety of metoclopramide for the fetus when the drug is given to women to relieve nausea and vomiting during pregnancy."

Source : www.latimes.com

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