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Glaxo to withdraw Lotronex from the U.S. market

Glaxo to withdraw Lotronex from the U.S. market

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Posted by IBS2000 on November 28, 2000 at 16:46:02:

Glaxo Wellcome to withdraw Lotronex from the U.S. market

Decision follows in-depth discussions with FDA

RESEARCH TRIANGLE PARK, N.C. (November 28, 2000) – At the request of the U.S. Food and Drug Administration, Glaxo Wellcome Inc. announced today that it will voluntarily withdraw its prescription medicine, Lotronexâ (alosetron HCl) for the treatment of women with diarrhea predominant irritable bowel syndrome. While the company disagrees with the FDA’s assessment of the safety profile of the product, Glaxo Wellcome will cease distribution of Lotronex immediately.

Glaxo Wellcome took this step after in-depth discussions with the U.S. Food and Drug Administration about gastrointestinal side effects that occurred in association with the use of Lotronex. There have also been rare reports of fatalities from complications of gastrointestinal events although a causal relationship to Lotronex has not been established. Glaxo Wellcome has proposed a range of elements that the company believed would adequately and effectively address these risks. These have included further label modifications, restricted distribution, on-going patient education, new clinical and epidemiological research and use of an independent medical review board. The FDA, however, disagrees as to the adequacy of these proposals and has requested that Glaxo Wellcome voluntarily withdraw Lotronex from the market.

“We greatly regret this outcome and believe that Lotronex is effective, that its side effects are manageable, and that the benefits of the product when treating IBS outweigh the risks,” said James Palmer, M.D., Glaxo Wellcome plc Senior Vice President and Director, Group Medical Regulatory and Product Strategy. “Thousands of women are benefiting from Lotronex, and without this medicine, many of these women will have to resort to therapies that did not adequately treat their symptoms in the past.”

Palmer said that Glaxo Wellcome takes a different view from FDA on the ability to educate physicians and patients about the management of potential side effects and benefits of Lotronex.

Irritable bowel syndrome is a chronic, recurring condition that affects an estimated 1 in 5 Americans. Although the cause is unknown, IBS is characterized by multiple symptoms that include chronic or recurrent abdominal pain and discomfort and irregular bowel function.

Lotronex received FDA approval for the treatment of women with diarrhea-predominant IBS in the U.S. on Feb. 9, 2000. It is the first medicine in many years proven in well-controlled large clinical trials to address multiple symptoms of the condition. More then 450,000 prescriptions have been written since the drug became available in March 2000.

In line with the company’s practice, Glaxo Wellcome has closely monitored the safety profile of Lotronex since its introduction. In cooperation with the FDA, Glaxo Wellcome has provided updated and extensive information on appropriate use to both health care providers and patients.

Glaxo Wellcome representatives will immediately contact health care professionals to advise them of the discontinuation of distribution and marketing. Physicians will then begin contacting their patients to discuss a plan to transition them to alternative therapies.

For more information, health care providers and patients may call 1-888-TALK 2 GW (1-888-825-5249)
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