After meetings with Food and Drug Administration (FDA), Glaxo Wellcome has made the decision to pull Lotronex (alosetron hydrochloride) from the market.

     Lotronex is used by women who have predominantly diarrhea causing Irritable Bowel Syndrome (IBS).

     The FDA studied 70 cases of adverse reactions to the drug, including 5 deaths. The main concern was the potential for damage to the intestine from either ischemic colitis or severe constipation. Ischemic colitis is a condition where blood flow to the intestine is decreased. The symptoms include pain, fever, and bloody diarrhea.

Of the 70 cases reviewed:

• 49 were cases of ischemic colitis.
• 21 were cases of severe constipation.
• 34 cases resulted in hospitalization.
• 10 cases resulted in surgical procedures.
• 3 cases resulted in death.

     After completing the review, the FDA gave Glaxo Wellcome the option of a "restricted drug distribution program". This would include continued clinical research, closer monitoring of patients severely debilitated by IBS who were using Lotronex, and the safe use of Lotronex in informed patients.Glaxo Wellcome elected to pull the drug from the market.

     Lotronex was approved by the FDA on February 9, 2000. Four cases of ischemic colitis were reported before the drug was approved. The condition reversed when the drug was discontinued, and all four cases were considered to be mild to moderate in severity.