Lotronex / Alosetron Hydrochloride
Lotronex was used to treat Irritable Bowel Syndrome (IBS) and its symptoms, including abdominal pain and problems with bowel movements. The drug, manufactured by GlaxoSmithKline and approved by the FDA in February 2000, has since been recalled.
FDA investigators discovered that the use of Lotronex could result in ischemic colitis, a potentially life threatening condition which is caused by reduced blood flow to the colon. Additionally, the drug can cause severe constipation, which can result in a ruptured bowel. As of October 2000 there had been 91 incidences of hospitalization (many more likely went unreported) in which some patients required surgery and at least five died. As a result, GlaxoSmithKline agreed to remove the drug from the market in November 2000.
In June 2002, the FDA, facing pressure from desperate patients who pleaded for the drug's return, lifted the ban on Lotronex. The FDA approved a supplemental New Drug Application (sNDA) that permits marketing of Lotronex with tough restrictions.
See your doctor if you have experienced serious side effects associated with Lotronex. In addition, it may be important to contact an attorney who can help you protect your legal rights. Please keep in mind that there may be time limits within which you must commence suit.
Attorneys associated with InjuryBoard.com will evaluate your case free of charge. In addition, you will not pay any fees or costs unless your attorney recovers money for you. Please click on the free Ask An Attorney button to take advantage of this valuable service.
-- Article Courtesy of InjuryBoard.com
More ...
- Lotronex Killed at Least Five
- FDA Knew of Lotronex Dangers
- Government Panel Recommends Lotronex's Return
.