Avandia Alert

Patients Advised to Contact Their Physician

In response to a safety alert issued by the U.S. Food and Drug Administration (FDA), Froedtert & the Medical College of Wisconsin will send a letter to all patients who have received a prescription for Avandia within the last year.

“New information suggests that there may be a small but increased risk of heart problems for people with type 2 diabetes who are taking this drug,” said Medical College of Wisconsin endocrinologist Irene O’Shaughnessy, MD, FACP. “We will be notifying patients to discuss the continued use of this drug with their primary care physician at their next office visit.”

The letter will go to outpatients seen at Froedtert & the Medical College clinics. Avandia is not used for inpatient treatment at the facility.

On May 21, the FDA issued a safety alert on Avandia, a drug approved to treat type 2 diabetes. According to the alert, “controlled clinical trials of the drug have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia.” To date, the FDA has not taken any action to remove the drug from the market.

The FDA recommends that people who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack, should talk to their doctor about this new information.

The FDA said it is “carefully weighing several sources of data, some of which show conflicting results, related to the risk of heart attack and heart-related deaths in patients treated with Avandia, and will complete its analyses and make the results available as soon as possible.”

Author: Marla Fraunfelder

Date: May 25, 2007

Medical Reviewer:

Irene O’Shaughnessy, MD, FACP

Online Editor(s): Christopher Sadler