Pharmaceutical maker GlaxoSmithKline is seeking approval from the U.S. Food and Drug Administration (FDA) to reintroduce the irritable bowel syndrome (IBS) drug Lotronex. The gastrointestinal drug was recalled in November 2000 after FDA investigators discovered that the use of Lotronex could result in ischemic colitis, a potentially life threatening condition caused by reduced blood flow to the colon. Glaxo and the FDA have received thousands of letters from patients asking for the drug's return since it was pulled from the market.

To win FDA approval to resume the sale of Lotronex, Glaxo plans to institute several new restrictions. Under the plan, only experienced IBS physicians would be allowed to prescribe Lotronex and the allotted dosage would be significantly reduced. Women, whom the drug is intended for, would also have to sign a consent form stating they are aware of the potential side effects. The FDA plans to seek advice from a panel of doctors and scientists before making a decision on the drug's reintroduction.