U.S. Lets Drug Tied to Deaths Back on Market. Lotronex, a real advance in the treatment of irritable bowel syndrome, was withdrawn voluntarily at the FDA’s request after the manufacturer and the FDA could not agree on marketing restrictions to reduce severe side effects and risk of death which became apparent in post-marketing surveillance. “But thousands of patients protested the withdrawal, saying Lotronex was the only treatment to have aided them. Their pleas helped to persuade the agency and manufacturer to find a way to reinstate it. Lotronex will return, the agency said — with restrictions. The new rules leave considerable responsibility with doctors, pharmacists and patients to use it correctly and to watch for early signs of intestinal problems, which can be fatal.” On the one hand, leaving responsibility with physicians and patients subject to informed consent is a reasonable, laudable approach. On the other hand, I worry about leaving responsibility in the hands of physicians and patients. NY Times