Reglan Lawsuits News

by Steve Fields on January 14th, 2010

Reglan And Metoclopramide Use While Pregnant

Reglan lawsuits continue to be filed by individuals and families affected by serious side effects including Tardive Dyskinesia. Pregnant women have been using drugs containing metoclopramide (the generic version of Reglan) in order to reduce the severity of symptoms associated with morning sickness. To be sure, these drugs can effectively minimize vomiting and nausea. By triggering muscle contractions within the gastrointestinal tract, they help empty the stomach more quickly, allowing the contents to enter the intestines. However, the safety of using these products is still hotly debated.

The Food and Drug Administration (FDA) issued a black box warning on Reglan products in February 2009. The impetus behind the warning (since published) was a doubling of the number of adverse effects related to the use of metoclopramide drugs between 2006 and 2008. The boxed warning, along with this recent data, has renewed interest in the debate regarding whether it is safe to use these products during pregnancy.

Below, we’ll approach this topic from the context of a recent study released by the New England Journal of Medicine. I’ll summarize their findings and explain what the study fails to reveal.

Overview Of NEJM’s Recent Reglan Study

In June 2009, the New England Journal of Medicine published a study titled, “The Safety Of Metoclopramide Use In The First Trimester of Pregnancy.” In this report, they revealed their findings based upon a population size of 81,703 infants born in Israel. Of them, 3,458 were born to mothers who used metoclopramide products to relieve symptoms related to morning sickness.

The NEJM study found that 4,016 babies manifested severe birth defects. However, there was no marked difference in the number of birth defects attributed to mothers who had taken drugs containing metoclopramide when compared to those who had not. As noted by an article published by the Washington Post dated June 30th, 2009, five percent of the babies born to mothers taking the generic version of Reglan exhibited birth defects. This was the same percentage of babies born with birth defects to mothers who had not taken the drug.

On the surface, this study seems to imply that the use of metoclopramide products is not harmful to unborn babies during the first trimester. The problem is, it neglects to address a few critical details.

What The Study Neglects To Emphasize

First, it’s worth noting the FDA does not approve the use of Reglan during pregnancy. That said, doctors can still prescribe the drug off-label for morning sickness. Because symptoms related to morning sickness can often extend past four months, many pregnant women use metoclopramide products longer than they should. Indeed, the FDA’s black box warning advises people to avoid taking the drug for periods exceeding three months. The reason is due to studies showing that 1 out of 5 people who have developed Reglan-induced tardive dyskinesia did so after using the drug for more than 12 consecutive weeks.

While the NEJM’s study provides valuable insight into the safety of unborn babies exposed to metoclopramide during the first trimester, its findings can be easily misinterpreted. That leads to a false sense of safety. When pregnant women suffer from vomiting and nausea into their second trimester, the temptation exists to continue using the drug. Unfortunately, long-term Reglan use dramatically increases the likelihood of developing severe side effects, including tardive dyskinesia.

If you or a family member are already suffering from the devastating side effects of long-term metoclopramide use, contact a Reglan lawyer to explore your options including being part of Reglan lawsuits.