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Spiriva HandiHaler May Increase Stroke Risk

Mar 19, 2008 | Parker Waichman LLP Spiriva HandiHaler, a treatment for chronic obstructive pulmonary disease (COPD), could increase the risk of stroke, the Food & Drug Administration (FDA) said yesterday. In a statement, the FDA said it had decided to begin a  safety review of Spiriva after the drug's manufacturer, Boehringer Ingelheim GMBH, informed the agency of studies that indicated a higher stroke risk among Spiriva users.

Spiriva HandiHaler was approved by the FDA in 2004, and it is co-marketed by Boehringer and Pfizer, Inc.  Spiriva is a long-acting, 24 hour, anticholinergic bronchodilator used in the management of COPD. The Spiriva capsules are placed in the HandiHaler devices, and the patient inhales the medicine.  Spiriva is used once a day to prevent COPD symptoms. According to the National Institutes of Health, COPD is the fourth leading cause of death in the U.S., and is primarily caused by smoking. The disease causes the lungs' airway to become partly obstructed, making it difficult to breathe.

In an early communication released yesterday, the FDA said that Boehringer had recently submitted 29 studies involving Spiriva, which showed a slightly higher rate of stroke among patients treated with Spiriva compared to those not receiving the drug. Most of the studies looked at Spiriva's HandiHaler.  According to those studies, the FDA said the estimated risk of stroke presented by Spiriva are eight patients per 1,000 patients treated for one year with Spiriva and six patients per 1,000 patients treated for one year with placebo, meaning the estimated excess risk of a stroke possibly associated with Spiriva is two patients for each 1,000 patients over one year.

The FDA said the risk assessment was not yet conclusive, but it was issuing a statement as part of an effort to tell doctors and patients about potential problems as soon as possible.  The FDA also said the results of a large, four-year study involving Spiriva are expected to become available in June which should contain additional safety information.

The FDA maintains that Spiriva HandiHaler is an effective medicine  for the treatment of COPD, including chronic bronchitis and emphysema. The FDA said patients should not stop taking Spiriva HandiHaler before talking to their doctor if they have questions about this new information.

This is the second time this month the FDA has issued an advisory regarding Spiriva.  On March 4, the FDA said in a Public Health Advisory that both the agency and the American Association of Poison Control Center National Poison Data System had received many reports of patients swallowing Spiriva and Foradil (another COPD treatment) capsules rather than placing the capsules in their inhalation devices. Reports of ingestions indicated that few patients experienced side effects from the swallowed capsules. In that advisory, the FDA cautioned doctors, nurses, and pharmacists to discuss with patients how to correctly use the Spiriva HandiHaler or Foradil Aerolizer. The FDA also said that if a patient who is prescribed Spiriva or Foradil does not experience breathing improvement, the health care provider should ask the patient if he or she is swallowing the medicine rather than inhaling it.

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