After CA tort decision, Reglan gets black box

FDA is slapping a black-box warning on Reglan (metoclopramide) drugs, widely used by patients with chronic heartburn and other gastrointestinal disorders. Originated by Wyeth, the tablet form was sold to Schwarz Pharma and the injectable to Baxter Healthcare several years ago, and it's marketed as a generic by several other companies, the Associated Press reports.

The new black box warns of the risk of tardive dyskinesia, a neurological disorder that causes muscle spasms and repetitive movements. The risk grows with prolonged use of the drug or with high doses of it, and it usually continues even after the drug is stopped, the warning states. "The chronic use of metoclopramide therapy should be avoided in all but rare cases where the benefit is believed to outweigh the risk," said CDER chief Janet Woodcock.

The warning comes on the heels of a California court case, in which a plaintiff treated with generic versions of Reglan developed tardive dyskinesia. Wyeth was held liable for failing to properly warn of the risk of injury, despite the fact that the patient never actually took the Wyeth form of the drug. Apparently generics makers just passed along Wyeth's patient information about it, which, in the court's view, made Wyeth accountable. The bold, black boxed warning should take care of any future failure-to-warn problems, eh?

- see the FDA release
- check out the story from Dow Jones
- read the AP article