Does Reglan Study Provide a False Sense of Security?

Beersheba, ISRAELA recent study on off-label use of Reglan for morning sickness proved initially reassuring for expectant mothers who were concerned about the possibility of Reglan side effects in infants. However, critics say that the study doesn't tell the whole story.

The US Food and Drug Administration (FDA) has not approved the use of Reglan (metoclopramide) to treat nausea and morning sickness in pregnant women, but doctors have been prescribing the drug off-label for that purpose for years. Metoclopramide is a much more common antidote for morning sickness in Europe and Israel than it is in North America.

A report conducted by Israeli scientists and published in the 6/11/09 issue of the New England Journal of Medicine (NEJM) supports the view that Reglan is safe for both mother and fetus. Led by Ilan Matok of Ben-Gurion University of the Negev in Beersheba, Israel, a team of researchers studied 81,703 births among women enrolled in Israel's largest health maintenance organization. 3,458 of the women took metoclopramide during their pregnancies.

Matok and colleagues reported 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."

However, the study appeared just a few months after the FDA issued a black box warning for Reglan. The new warning states that metoclopramide can cause tardive dyskinesia, a neurological disorder characterized by the involuntary movements of eyes, facial muscles, the tongue, limbs and other extremities. Reglan injury lawyer Roger D. Drake emphasizes that that the risk for tardive dyskinesia increases with treatment beyond 12 weeks, and that it can appear at any time. Doctors do not understand why this happens, and there is no known cure.

The Israeli study made no mention of tardive dyskensia. It also fails to mention the possibility for metoclopramide to pass through a mother's breast milk to her baby.

The history of drugs previously considered safe and used to combat morning sickness will bring back horrific memories for an earlier generation. Thalidomide was widely used in Europe in Canada in the 1960s, according to MSNBC, until babies were born with missing or shortened limbs. Later, Bendectin was pulled from the market in 1983 after medical authorities began suspecting that it caused limb deformities in infants.

Experts told MSNBC that the Israeli study would likely prompt obstetricians to prescribe Reglan more often for morning sickness. However, health authorities remain concerned about off-label use of the drug.