Glaxo on Lotronex

Re “FDA Minimized Issue of Lotronex’s Safety,” Nov. 2: It is untrue that Glaxo Wellcome and the FDA have not taken seriously reports of adverse events among women who have taken Lotronex. Both Glaxo Wellcome and the FDA apply the world’s highest standards in our efforts to make innovative medicines available. We both have independently scrutinized the benefits and risks and have concluded that, in appropriate patients, Lotronex has a demonstrated benefit in the treatment of diarrhea-predominant irritable bowel syndrome, which can be severely incapacitating.

Your story failed to report that physicians were prominently alerted in the original prescribing information for Lotronex that ischemic colitis and constipation were potential adverse events. As we learn more about Lotronex in daily medical practice, we update prescribing information, educational materials, journal advertising and product literature. This is standard procedure for all medicines. Our goal is to provide detailed information so physicians can know who might benefit from the medicine. We also want physicians and their patients to recognize warning signs of rare but serious risks and take early action to prevent harm.

Glaxo Wellcome conducts all research with the highest of medical standards. Keeping the needs of the patient as our top priority is not only ethical conduct, it is sound medicine and sound business.

GEORGE J. MORROW

President, Glaxo Wellcome Inc.

Research Triangle Park, N.C.