News for February, 2010

Why did FDA take so long to place black box warning on Reglan?

black box warning 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 on the medication, Reglan. A 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.

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Black box warning on Reglan came too late for some

black box warning Black box warning on Reglan came too late for someMetoclopramide, known by the brand name Reglan, is one of the leading medications prescribed to treat gastroesophageal reflux disease (GERD) and gastroparesis, a condition in which the stomach takes too long to empty its contents. What many don’t know is that was first used to treat psychosis in patients, but it was found to show more promise as a drug to treat gastrointestinal disorders. Unfortunately, like many medications used to treat psychosis, also increased one’s risk of developing a severe movement disorder known as Tardive Dyskinesia.

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