The U.S. Food and Drug Administration issued a statement concerning Pfizer’s drug Spiriva stating that the drug may increase the risk of stroke.
While the FDA stated that the risk assessment of the lung drug is not conclusive, the agency wanted to issue a statement in an effort to notify doctors and patients about potential problems as early as possible. The drug is marketed by Pfizer and Boehringer Ingelheim Pharmaceuticals and the FDA is working in conjunction with Boehringer to evaluate the risk.
Spiriva (tiotropium) is used to treat COPD, chronic obstructive pulmonary disease. In a preliminary analysis of about 13,500 patients in 29 clinical studies found the risk of stroke increased from 6 in 1,000 of patients taking a placebo to 8 in 1,000 of those taking Spiriva.
The early statement is the FDA’s defense against recent criticisms over failure to notify the public quickly over potential risks concerning drugs and medical devices. The FDA posted on its Web site "It is important to interpret these preliminary results with caution. FDA has not confirmed these analyses."The agency said patients should not stop taking Spiriva but should continue to report problems to the agency.
[Souce: MedlinePlus]
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