Black box warning on Reglan came too late for some
February 9th, 2010 by Jennifer Walker-Journey
Metoclopramide, known by the brand name Reglan, is one of the leading medications prescribed to treat gastroesophageal reflux disease (GERD) and gastroparesis, a condition in which the stomach takes too long to empty its contents. What many don’t know is that metoclopramide was first used to treat psychosis in patients, but it was found to show more promise as a drug to treat gastrointestinal disorders. Unfortunately, like many medications used to treat psychosis, metoclopramide also increased one’s risk of developing a severe movement disorder known as Tardive Dyskinesia.
Tardive Dyskensia is a condition in which a person develops involuntary movements that can include lip smacking, facial grimacing, tongue thrusting, eye blinking and bulging, head jerking, and involuntary movements of the fingers. It can be debilitating for those who suffer from the condition. Metoclopramide carries the greatest risk when it is taken for 12 weeks or longer. Women and the elderly are at higher risk, and there is known know cure. Even after stopping the medication, the symptoms may persist.
In early 2009, the Food and Drug Administration (FDA) issued a black box warning – the agency’s sternest warning reserved for drugs that carry a risk of serious adverse events – on metoclopramide, urging doctors to avoid long-term use of the drug except in rare cases where the benefits outweigh the risks. That warning came too late for many patients, who are now handicapped because of the medication.