New research indicates that the anti-nausea drug metoclopramide, generally known by the brand name Reglan, is safe for short-term use among pregnant women to combat morning sickness.
The study was published in the most recent issue of the New England Journal of Medicine, and found that there was no statistically significant increase in birth defects, malformations or low birth weight in infants born from women who took Reglan for nausea during pregnancy.
The study looked at a total of 81,703 births in southern Israel over the last decade. Of those births, there were 3,458 where the mother used metoclopramide to alleviate morning sickness symptoms. While there was a slight increase of 0.5% to 0.2% of birth defects or malformations, that number is too small to be statistically significant, researchers noted.
“Exposure to metoclopramide in the first trimester was not associated with significantly increased risks of any of several adverse outcomes,” the study states. “These findings provide reassurance regarding the safety of metoclopramide for the fetus when the drug is given to women to relieve nausea and vomiting during pregnancy.”
Reglan (metoclopramide) is approved in the United States by the FDA for the short-term treatment of gastrointestinal disorders like diabetic gastroparesis, gastroesphageal flux (GERD) and delayed gastric emptying. While it is commonly used to treat even mild cases of pregnancy nausea in Europe and other foreign countries, doctors in the United States tend to prescribe the drug off-label only in cases of extreme morning sickness.
In February 2009, the FDA required the manufacturers of all metoclopramide drugs to add a “black box” warning to the medications about potential tardive dyskinesia Reglan side effects, which can cause repetitive and involuntary muscle movements. However, that risk is primarily associated with long-term use of more than 12 weeks, and use to treat morning sickness would only involve short-term use.
A number of Reglan lawsuits are currently pending throughout the United States against the manufacturers of metoclopramide drugs, alleging that they failed to adequately research the long-term effects of the drug or warn about the potential risk of tardive dyskinesia and other neurological disorders.
Tardive dyskinesia is primarily associated with repetitive and involuntary movements of the lower face and limbs, including grimacing, chewing, smacking of gums and impaired finger movements. There is no known effective treatment, and the problems often continue even after the long-term use of Reglan is discontinued.