Government Panel Recommends Lotronex's Return
April 24, 2002
A government panel of scientists and doctors assembled by the U.S. Food and Drug Administration (FDA) recommended yesterday the return of the gastrointestinal drug Lotronex. Since the drug was pulled from the market in November 2000, GlaxoSmithKline, Lotronex's maker, and the FDA have received thousands of letters from patients suffering from irritable bowel syndrome (IBS) asking for the drug's reintroduction.
If the FDA approves Lotronex's return, several new restrictions will be implemented. Under Glaxo's plan, only experienced IBS physicians will be allowed to prescribe Lotronex and the allotted dosage will be significantly reduced. Women, whom the drug is intended for, will also have to sign a consent form stating they are aware of the drug's potential side effects. Patients will also have to register with a national database designed to monitor their health while using the drug.
Critics, though, say it is too risky to sell Lotronex again. A spokesperson for the watchdog organization Public Citizen told the government panel during its inquiry that the drug's reintroduction would be a "serious public health mistake".
-- Article Courtesy of InjuryBoard.com
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