A new study by researchers from Denmark suggests that there is no link between the anti-nausea drug Reglan and birth defects when taken by pregnant women.
The research was published in the Journal of the American Medical Association (JAMA) on October 16, indicating that 10% to 15% of pregnant women need drugs to help deal with nausea problems.
While concerns have existed that side effects of Reglan (metoclopramide) may increase the risk of birth defects, researchers found no significant increase in health problems among children born to women who used the medication during pregnancy.
Researchers looked at 1,222,503 pregnancies in Denmark from 1997 to 2011, consisting of both women who were and were not exposed to Reglan. There were 25.3 cases of congenital malformation per 1,000 pregnancies among women who took Reglan. But there were 26.6 cases per 1,000 pregnancies among women who did not take the drug.
The study also failed to find any association between Reglan and miscarriages or malformations of any kind.
Reglan is approved for the short-term treatment of gastrointestinal disorders, such as diabetic gastroparesis, gastroesphageal reflux (GERD) and delayed gastric emptying. While the brand name version of the drug is no longer marketed, it is widely available as generic metoclopramide.
In addition to concerns about the link between Reglan and birth defects, side effects of the long-term use of the medication has been linked to reports of neurological problems in recent years, including a rare movement disorder known as tardive dyskinesia, which may leave patients with uncontrollable movement problems that continue even after the medication is no longer used. Although Reglan is only designed for short-term treatment, when used outside of pregnancy, it is often prescribed for longer periods of time due to the often chronic persistence of the gastrointestinal disorders that result in nausea symptoms.
In the United States, the FDA required the manufacturers of all medications containing metoclopramide to update the warning label in February 2009, providing information that users may face an increased risk of tardive dyskinesia when the medications are used at high doses or for a long period of time.
Symptoms of tardive dyskinesia can include grimacing, chewing, smacking of lips, rapid eye movements and impaired finger movements. There is no known effective treatment of the socially debilitating disorder, and the involuntary movements can be permanent, persisting even after use of the drug has stopped.