FDA reviewing information about potential Spiriva stroke side effects
The FDA has issued an early communication about a possible connection between Spiriva HandiHaler and an increased risk of stroke. The drug regulators indicate that they are currently reviewing additional safety information about Spiriva side effects, and will announce any conclusions and recommendations to the public later this year after data from a four year study has been received and analyzed.
>>FDA EARLY COMMUNICATION: Spiriva Stroke Risk
Spiriva HandiHaler, which contains tiotropium bromide , is manufactured by Boehringer Ingelheim and marketed by the drug company together with Pfizer . The once-daily medicine is approved for long-term treatment of bronchospasm associated with COPD (chronic obstructive pulmonary disease), including chronic bronchitis and emphysema.
According to pooled results from 29 different clinical trials, individuals treated with Spiriva for one year may face an increased risk of suffering a stroke. Data has been reviewed involving 13,500 individuals with COPD who were treated with Spiriva HandiHaler or Spiriva Respimat, which is another forumlation approved in Europe. Preliminary estimates indicate that approximately 8 out of every 1,000 individuals treated with Spriiva for one year suffered a stroke, compared with 6 out of every 1,000 for those treated with a placebo.
Additional information about the Spiriva stroke risk is expected in June 2008. That is when data from a large four year study will be released involving long-term safety data. The study, known as UPLIFT (Understanding the Potential Long-Term Impacts on Function with Tiotropium) was conducted by the drug’s manufacturer, Boehringer Ingelheim.
The FDA indicated that they are currently reviewing post-marketing adverse event reports of Spiriva side effects, and they have requested additional information from the manufacturer so that they may determine whether any regulator actions are warranted. An early communication is a statement by the FDA about safety concerns associated with a medication. However, it does not mean that they have concluded that there is a causal relationship between the drug’s side effects and the emerging safety issue.
The FDA has indicated that individuals should not stop taking Spiriva HandiHaler based on this early communication and they should contact their doctors with any questions about this new information. Doctors and patients have been urged to report any Spiriva HandiHaler side effects by calling (800) 332-1088 or online at www.fda.gov/medwatch/report.htm.
If you, a friend or family member suffered a Spiriva HandiHaler stroke, review the potential legal options which may be available by requesting a free consultation and claim evaluation.
