For medications inarguably linked to serious medical complications, the FDA issues what is known as a black box warning label. This regulation requires the manufacturer to publish a warning on all packaging which clearly states the risks and side effects most prominently associated with the drug in question. The FDA does not often exercise this option, preferring to respect the free market in the majority of cases, since the general procedures for the review and production of medicine usually are sufficient. However, when it does require the warning, the matter must certainly be paid very strict attention.
In the case of Reglan, the FDA required a black box warning for the medicine in February of 2009. This warning reads as follows, in its complete form:
WARNING: TARDIVE DYSKINESIA Chronic treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible. The risk of developing tardive dyskinesia increases with the duration of treatment and the total cumulative dose. The elderly, especially elderly women, are most likely to develop this condition.
Metoclopramide therapy should routinely be discontinued in patients who develop signs or symptoms of tardive dyskinesia. There is no known treatment for tardive dyskinesia; however, in some patients symptoms may lessen or resolve after metoclopramide treatment is stopped.
Prolonged treatment (greater than 12 weeks) with metoclopramide should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risks to the patient of developing tardive dyskinesia.
(Metoclopramide is the chemical name for Reglan.)
This kind of warning is very valuable for patients of Reglan because it doesn’t allow any serious argument about the matter. It clearly states that the drug is causally linked to the development of Tardive Dyskinesia, and that patients should not take the medicine for periods longer than recommended, as this is suspected to aggravate the risk. Warnings such as these are some of the most important tools in the defense of patients who have unfortunately contracted complications from their prescriptions.