Public Citizen Criticizes Lotronex's Reintroduction
June 11, 2002
Government watchdog Public Citizen criticized the U.S. Food and Drug Administration (FDA) last week for approving the reintroduction of the gastrointestinal drug Lotronex. In a press release issued last Friday, the interest group warned consumers that the new FDA restrictions are inadequate. According to Public Citizen, the new recommended dosage (1mg daily) has been linked to an increased risk of adverse events. The organization's data indicates that 12 percent of the first 70 cases of ischemic colitis reported to the FDA involved a dosage level of 1mg.
Public Citizen is also asking the FDA to institute a monitoring system for Lotronex patients to properly determine if harmful side effects return. The drug's maker, GlaxoSmithKline, will be overseeing the new guidelines, which Public Citizen says is a clear conflict of interest.
Lotronex, used to treat irritable bowel syndrome, was removed from the market in November 2000 after the drug was linked to dozens of cases of severe side effects and at least five deaths.
-- Article Courtesy of InjuryBoard.com
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