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Thursday September 2, 2010

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Heartburn Pill Reglan Found to Help Quell Pregnancy Morning Sickness

Women who experience morning sickness early in their pregnancies may find safe, effective relief in a drug commonly given to treat heartburn, a new study suggests.

The drug, metoclopramide, is sold in the United States under the brand name Reglan and is approved to treat a variety of gastrointestinal disorders. About two million Americans take the drug for heartburn and similar disorders, but Reglan is not approved to treat pregnancy morning sickness in the United States, although it is used for that treatment in Europe.

A study conducted by researchers in Israel found that Reglan can relieve the occasional queasiness and morning sickness brought on early in pregnancy and does not result in birth defects, low birth weight, premature birth, or fetal death. The study focused on about 3,500 pregnant women.

Reglan Linked To Serious Injuries

However, Reglan is not without controversy. Earlier this year, the Food and Drug Administration ordered the drug’s packaging to carry a prominent “Black Box” warning to notify users and physicians about the risks of severe, permanent injury from long-term or high-dose use. The FDA said using the drug for longer than 12 weeks was not recommended.

The FDA found that people taking Reglan for longer times or at higher doses were at increased risk of developing tardive dyskinesia, a permanent disorder that causes involuntary movements of the face and extremities. People with tardive dyskinesia may develop lip smacking, rapid and involuntary movement of the arms, fingers, legs, and body, grimacing, and protrusion of the tongue.

Reglan has not been approved by the FDA to treat morning sickness in pregnant women and the effects of the drug on both women and their developing fetuses have not been extensively studied, according to authors of the study. However, methoclopramide is prescribed in many European countries to treat the common and uncomfortable side effect of pregnancy, officials said.

The study focused only on short-term use of Reglan during pregnancy and did researchers said the drug is only given “for short terms and as needed.”

Results of the new study of Reglan in treating pregnancy morning sickness appear in the June 11 issue of the New England Journal of Medicine.

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