FDA finally orders Black Box on Reglan and others containing metoclopramide

At the end of February, the FDA ordered that a “black box” warning highlighting the risk of tardive dyskinesia (“TD”) and other serious neurological side effects be placed on all drugs that contain metoclopramide, including Reglan. Although the FDA has long been aware of the risk of TD when dopamine blockers such as Reglan are used, apparently the drug is still being prescribed for longer periods of time than the 4-12 week recommendation, which only further increases the likelihood of developing TD, an untreatable disorder with life-altering, sometimes permanent, symptoms.

Reglan is prescribed to treat various gastrointenstinal disorders, including but not limited to the slow stomach emptying that can occur in tandem with diabetes. Reglan has also been pushed on doctors as a second-line treatment for heartburn stemming from gastroesophageal reflux.

Tardive dyskinesia is characterized by involuntary and repetitive movements of the body including: lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering, impaired movement of the fingers, and tremors. These often irreversible symptoms may lessen or resolve after metoclopramide treatment is stopped. Still, some people can get so bad it’s hard for them to eat and swallow because of their tongue movements, and yet others experience tremors for years and years after use is discontinued.

TD occurs in about 25 percent of all patients taking dopamine-blockers, including metoclopramide. Those at greatest risk include the elderly, especially older women, and people who have been on the drug for a long time.

If you or a loved one has taken Reglan or any other drug containing metoclopramide and been diagnosed with tardive dyskinesia, please contact us for an free consultation. Pogust Braslow & Millrood LLC works tirelessly to protect the rights of consumers affected by the pharmaceutical industry and is at the forefront of many such litigations throughout the country.