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The FDA is requiring the manufacturers of metoclopramide (Reglan®) include a boxed warning on their labeling regarding the risk of long-term or high-dose use and tardive dyskinesia.

FDA Actions

January 2, 2015

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FDA Actions

The FDA is requiring the manufacturers of metoclopramide (Reglan®) include a boxed warning on their labeling regarding the risk of long-term or high-dose use and tardive dyskinesia. Manufacturers will also be required to implement a risk evaluation and medication strategy (REMS) to ensure patients are provided with a medication guide that discusses the risk. Metoclopramide is approved for the treatment of gastric motility problems associated with GERD, diabetic gastroparesis, and nausea and vomiting.

A new proton pump inhibitor has been approved by the FDA, bringing the number of PPIs on the market to six. Dexlansoprazole is the purified active isomer of lansoprazole (Pepcid®). The drug has a delayed-release formulation designed to provide two separate releases of the medication. It is approved for the treatment of GERD and erosive esophagitis. Takeda Pharmaceuticals will market dexlansoprazole as Kapidex™.