Wednesday, May 9, 2012
F.D.A. Staff Raises Concerns About Arthritis Drug
Federal regulators said Monday that an experimental pill being developed by Pfizer to treat rheumatoid arthritis raised “serious safety concerns” and was linked to a higher risk for lymphoma, a form of cancer, and serious infections. Pfizer has identified the drug, known as tofacitinib, as one of the most promising and lucrative prospects in its drug pipeline.
The briefing documents, prepared by F.D.A. staff members and released Monday ahead of the meeting, also found that although tofacitinib did ease the symptoms of rheumatoid arthritis and the physical functioning of those who have it, the studies didn’t definitively show that the drug stopped the disease from progressing.
Read about in the New York Times in an article by Katie Thomas at http://www.nytimes.com/2012/05/08/health/fda-staff-raises-concerns-about-arthritis-drug.html?partner=rss&emc=rss
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