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Second Lotronex recall requested
-May 5, 2004
Lotronex was approved in February 2000 to treat irritable bowel syndrome, but a Lotronex recall was issued by November 2000 after evidence of ischemic colitis. Ischemic colitis is a life-threatening condition where the bowel tissue dies because of a lack of blood flow to the colon. Public Citizen had petitioned the FDA for the removal of Lotronex in August 2000, three months before the recall was issued.
In 2002, after the Lotronex recall first occurred, Public Citizen's Health Research Group Director testified before the FDA committee and said that the reintroduction of the drug back to the market would be a "serious public health mistake". Lotronex was still reintroduced, and guidelines were made that physicians wanting to prescribe the drug had to sate they were qualified to diagnose IBS and to manage ischemic colitis and understands Lotronex risks.
Despite warnings, the Lotronex guidelines failed to include a way for doctors' qualifications to be verified and to make sure patients are informed of Lotronex risks. Of the spontaneous Lotronex adverse events reported, the rate of ischemic colitis is still higher than spontaneous reports made during its 2000 marketing.
For more information on Lotronex, please contact us.
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