Lotronex Killed at Least Five
May 20, 2001
It took less than 12 months for a promising new drug designed to fight irritable bowel syndrome to be removed from the market due to safety concerns. Lotronex, approved by the Food & Drug Administration (FDA) in February 2000, was pulled from the market today due to an alarming number of serious side effects, including life threatening ischemic colitis.
Lotronex, developed by GlaxoSmithKline, was the first of a new class of drugs used to treat irritable bowel syndrome. Since its approval several months ago, Lotronex has been prescribed over 500,000 times. The drug has also caused over 100 hospitalizations, nearly 50 for severe ischemic colitis, five cases of which proved deadly to Lotronex patients.
Lotronex was primarily used to treat diarrhea associated with irritable bowel syndrome, a condition affecting at least 15% of the U.S. population. Irritable bowel syndrome or "IBS" is characterized by unpredictable bowel movements and loose stools. Most sufferers of irritable bowel syndrome are women.
Despite FDA evidence that Lotronex only helps approximately 20% of IBS sufferers, a GlaxoSmithKline spokesperson had this to say on the drug's removal: "We greatly regret this outcome and believe that Lotronex is effective, that its side effects are manageable, and the benefits of the product when treating IBS outweigh the risks." While ischemic colitis can be mild, the condition can cause gangrene and death as it cuts off blood flow to the colon. While the severe version of ischemic colitis is relatively rare, the mild form of the condition may not be. According to Richard Kent, MD, GlaxoSmithKline's chief medical officer in the U.S., the mild version "probably occurs more frequently than is recognized."
Constipation, sometimes severe enough to require bowel surgery, is also a known side effect of Lotronex. However, GlaxoSmithKline denies that the drug causes an alarming number of serious cases of constipation. According to the company, many of the problems associated with Lotronex occur due to doctor error. The drug is designed primarily to treat diarrhea associated with irritable bowel syndrome, a condition occurring primarily in women. Many doctors have prescribed Lotronex to men and others who exhibit symptoms not associated with irritable bowel syndrome related diarrhea. According to the FDA, such practice unnecessarily exposes people who stand to benefit the least from Lotronex to the drug's life threatening side effects.
While it has taken until November 2000 for the FDA and GlaxoSmithKline to agree to remove the drug from the market, many watchdog groups have called for Lotronex's removal for many months. According to the consumer group Public Citizen, it is "irresponsible for GlaxoSmithKline and for the FDA to allow this doomed drug [Lotronex] to stay on the market any longer."
-- Article Courtesy of InjuryBoard.com
More ...
- FDA Knew of Lotronex Dangers
- Government Panel Recommends Lotronex's Return
- Lotronex / Alosetron Hydrochloride
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