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FDA Restricts Access to Avandia
Date:9/24/2010

these regulatory decisions affect them and their patients."

According to the company, worldwide sales of Avandia in the first half of 2010 totaled $500 million. In the United States, about 600,000 people are currently taking Avandia, Hamburg said.

Dr. Ronald Goldberg, a professor at the Diabetes Research Institute of the University of Miami Miller School of Medicine, said that "given all the evidence pointing to risk, even though it's not conclusive by any stretch of the imagination, it rises to a level to warrant restricting its [Avandia's] use."

Since there is a similar alternative, Actos, that hasn't been shown to increase cardiovascular risk, "you would think there would be very little place for Avandia," he said.

Goldberg said he will no longer prescribe Avandia, except to patients who have been using it for many years. In addition, going through the process to qualify patients for Avandia will deter many doctors from even considering Avandia as a treatment for diabetes, he said.

More information

For more information on diabetes, visit the U.S. National Library of Medicine.

SOURCES: Ronald Goldberg, M.D., professor, Diabetes Research Institute, University of Miami Miller School of Medicine; Sept. 23, 2010, teleconference with Margaret A. Hamburg, M.D., commissioner, Janet Woodock, M.D., director, Center for Drug Evaluation and Research, all U.S. Food and Drug Administration


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