Why did FDA take so long to place black box warning on Reglan?
In the February 1996 issue of the drug newsletter Worst Pills, Best Pills News, a story was published by the Health Research Group of Public Citizen warning that a drug commonly prescribed for heartburn and slow emptying of the stomach contents, a condition known as gastroparesis, could cause a serious movement disorder known as Tardive Dyskinesia. The condition could cause permanent disability in users, according to the report.
However, it took more than a decade for the Food and Drug Administration (FDA) to place a black box warning on the medication, Reglan. A black box warning is the strongest warning issued by the FDA and is placed on drugs that have potentially harmful or deadly side effects. Meanwhile, the drug was dispensed 6.5 million times in 2008 to an estimated 2 million Americans.