Reglan Study Says Metoclopramide Safe for Fetus, But for Mother?

Washington, DCA drug that is prescribed for nausea and other gastro-intestinal maladies carries of host of adverse reactions. A black box warning for Reglan tardive dyskinesia , as well as other Reglan side effects, should be sufficient for patients to consider whether, or not treatment with Reglan is a good idea. Reglan and tardive dyskinesia, a conditioned characterized by involuntary movements, is a concern to anyone who works in the public eye.

An individual may not be familiar with the term tardive dyskinesia (TD), but many would know it to see it: the involuntary twitching of the eyes, mouth or tongue. Depending upon the severity, TD can be devastating. A job that involves handling dangerous equipment, for example, would pose more danger for someone experiencing involuntary movement of the eyes. Employees who work in a retail establishment, or in the service sector may suddenly be deemed inappropriate for such tasks given these involuntary movements.

Reglan is metoclopramide which, according the web site US Recall News is used in the treatment of disorders such as heartburn caused by gastroesophageal reflux disease.

However, Reglan is also used to treat morning sickness in pregnant women in various parts of the globe. While Reglan does NOT carry approval from the US Food and Drug Administration (FDA) for that purpose in the US, Reglan is popular for that purpose elsewhere in the world and especially in Israel, according to a recent story in the Washington Post.

The June 30th, 2009 issue of the Washington Post carried a summary of a Reglan study that had been published in the June 11th, 2009 issue of the New England Journal of Medicine (NEJM). According to the account, given the widespread use of Reglan as a morning sickness aid in places such as Israel, the study attempted to answer the question as to whether, or not Reglan was safe for use by pregnant women.

The study, "The Safety of Metoclopramide Use in the First Trimester of Pregnancy," analyzed data on 81,703 infants including 3,458 whose mothers had taken Reglan (metoclopramide) to relieve nausea and vomiting during the first trimester of their pregnancy. Overall 4,016 infants were born with major birth defects—about 5 percent of the children who'd been exposed to the drug in utero and 5 percent whose mothers did not take the drug. There also was virtually no difference between the groups in the rate of premature births (6 percent), babies born underweight (8 percent) and infants who died shortly after birth (2 percent).

The study authors concluded, "In this large cohort of infants, exposure to metoclopramide in the first trimester was not associated with significantly increased risks of any of several adverse outcomes. 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."

While Reglan does not carry FDA approval for use by pregnant women in the US, doctors have the authority to prescribe medication off-label to their patients, for uses not necessarily approved and sanctioned by the FDA.

To that end, the black box warning for Reglan warns against the possibility of TD with Reglan use, together with the concern that the risk for TD increases the longer a patient is on the drug, or with higher doses. According to US Recall News, FDA studies have shown that 20 percent of patients who have developed TD as the result of ingesting metoclopramide, were on the drug for longer than three months.

In the case of pregnant women, the Washington Post online posting of June 30th highlights the fact that most pregnant women suffer morning sickness to some degree, although lengths vary. Usually commencing during the first month of pregnancy, morning sickness for the vast majority of sufferers continue until the 16th week, or four months into the pregnancy. However, for some women morning sickness can extend beyond the 16th week and for others can last for the entire pregnancy, which is nine months.

Thus, any pregnant woman prescribed Reglan for nausea could be taking the drug for longer than the three months cited in the black box warning mandated by the FDA.

While "The Safety of Metoclopramide Use in the First Trimester of Pregnancy" profiled in the June 11th NEJM suggests that metoclopramide does not harm the fetus, the possibility of prolonged Reglan use to fight nausea could serve as a risk for the mother within the context of developing TD.

Metoclopramide-induced TD often is minimized, or disappears altogether when the drug is stopped, but not always. Therefore Reglan side effects, including Reglan tardive dyskinesia can continue long after the drug is stopped. For those hapless souls, Reglan and tardive dyskinesia can evolve to a life-long issue.