Spiriva May Contribute to Stroke Risk: FDA Warning
Spiriva, a pulmonary drug marketed by Pfizer and Boehringer Ingelheim Pharmaceutical, appears to increase the risk of stroke, according to a public warning from the the U.S. Food and Drug Administration (FDA). Though a comprehensive assessment of the drug's safety is not yet complete, a potential for adverse events has prompted the agency to issue a warning, to assist patients and physicians in identifying any potential problems immediately.
Known also as tiotropium, Spiriva HandiHaler is used to treat chronic obstructive pulmonary disease (COPD).
A preliminary analysis of approximately 13,500 patients in 29 different clinical studies has demonstrated that the risk of stroke associated with the drug is 8 in 1,000 patients, compared with only 6 in 1,000 among those who took a placebo. The FDA has not yet confirmed these preliminary results. Four of the studies in question involved a version of Spiriva approved in Europe called Spiriva Respimat.
The FDA has warned that patients should not stop taking Spiriva right now, but should continue to report any problems via the Medwatch Online Voluntary Reporting Form -- an adverse events reporting program.
Previously on the DC Metro Area Medical Malpractice Law Blog, we have posted articles related to:
- Information on a Baxter Healthcare Heparin Recall
- Evidence that some dietary supplements promote development of prostate cancer
- A recent recall of Icy Hot therapy patches
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