The FDA has recently announced that drugs containing the antiemetic metoclopramide must carry a boxed warning about the risk of tardive dyskinesia. Risk of this condition is much higher with long-term usage and currently the existing labels already carry an un-boxed warning. The FDA recommends that treatment last no longer than three months.
Oftentimes, the symptoms of tardive dyskinesia can continue after stopping the drugs and are very rarely reversible. The FDA has said that manufacturers of the drugs that include metoclopramide must also implement a risk mitigation strategy that would ensure patients receive a medication guide with each prescription which details the risks.
Metoclopramide-containing drugs include tablets, syrups and injections which are used for short-term treatment of gastroesophageal reflux disease in patients who haven’t responded to other therapies.