Reglan Side Effects and Black Box Warning

Reglan, also known as metoclopramide, is a drug that is commonly used to treat gastrointestinal disorders and has recently come under scrutiny by the U.S. Food and Drug Administration (FDA). It has been discovered that the prolonged use of metoclopramide (more than 3 months) may be liked with an adverse and sometimes permanent side effect known in the medical community as tardive dyskinesia. Tardive dyskinesia is a condition which causes individuals to have involuntary body movements, such as lip smacking, tongue protrusion, grimacing, rapid blinking, or repetitive movements of the extremities. Individuals most susceptible to tardive dyskinesia as a side effect of Reglan are the elderly and more specifically elderly women. Even after the use of Reglan is discontinued, individuals may continue to suffer from the effects of tardive dyskinesia either temporarily or permanently. There is no known cure for tardive dyskinesia as this time.

When the FDA discovers that individuals taking a particular medication have experienced harmful side effects, the FDA can takes steps to ensure that both doctors and patients are aware of the serious side effects associated with the drug. Unfortunately, the public often pays a high price, usually with their health, before adequate warnings are provided regarding the side effects of certain medications. One step the FDA can take to warn both doctors and consumers of a medication’s likely side effects is placing a black box warning on the medication. Reglan (metoclopramide) is one such medication that now has a black box warning from the FDA. The black box warning is the most serious of the warnings that can be issued by the FDA and should be not be disregarded by doctors or potential consumers. The black box warning can help doctors and their patients determine if the probable risks associated with the medication are worth the relief the medication may provide to those suffering from gastrointestinal problems.

Reglan was designed to be a short-term treatment for those experiencing health issues such as Gastroesophageal Reflux Disease (GERD) and other related issues for which alternate treatments had proved unsuccessful. . Even though current warnings suggest that using the medication longer than 3 months may lead to tardive dyskinesia, a study by the FDA found that 20 percent of patients taking Reglan took the medication for longer than 3 months. It appears that tardive dyskinesia is directly related to the length of time the medication is used as well as the dosage taken by an individual to treat a gastrointestinal disorder. Individuals currently taking Reglan in syrup or tablet form or by injection should immediately report to their health care provider any adverse side effects, especially involuntary or repetitive movements.

Those consumers that have experienced or are experiencing symptoms of tardive dyskinesia due to the use of Reglan (metoclopramide) should also contact an experienced attorney for a consultation. Consumers that have been the victims Reglan injuries may be  entitled to monetary compensation for their medical bills and pain and suffering. At LaBovick Law Group, we have skilled and knowledgeable attorneys that will review each individual’s case, and can provide the individual with the expert legal counsel and guidance needed to successfully negotiate or litigate their personal injury case.