This withdrawal has been taken after in-depth discussions with the FDA about the interpretation of data relating to gastrointestinal side-effects which have occurred amongst patients treated with the product. These have included rare reports of fatalities, although no causal relationship with Lotronex has been established.
Glaxo Wellcome is withdrawing all regulatory submissions for alosetron.
During its discussions with the FDA, Glaxo Wellcome had proposed a range of initiatives to educate physicians and patients about the management of the potential side-effects and benefits of Lotronex, including further label modifications and patient education programmes. The FDA has indicated that it does not believe these proposals to be adequate, and has requested that voluntary withdrawal of Lotronex from the US market. Although the company disagrees with the FDA's assessment of the safety profile of the product, Glaxo Wellcome will comply with that request immediately.
"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 Dr James Palmer, Senior Vice President and Director Group Medical, Regulatory and Product Strategy, Glaxo Wellcome plc. "Thousands of women who have benefited from Lotronex will have to resort to therapies which did not adequately treat their symptoms in
Lotronex received FDA approval for marketing in the US on 9 February 2000 for the treatment of women with diarrhoea-predominant IBS. It is the first medicine proven in well-controlled large clinical trials to address the multiple symptoms of the condition. Approximately 500,000 prescriptions have been written since the drug became available in March 2000.
Lotronex is also approved but not yet marketed in Mexico, Argentina, Brazil and South Korea and there are also over 30 regulatory submissions pending around the world. Discussions are being initiated with regulatory authorities with a view to relinquishing licenses where granted and withdrawing all regulatory submissions.