An <"http://www.yourlawyer.com/practice_areas/defective_drugs">Avodart study has found a possible link between the drug and heart failure when it is taken to prevent prostate cancer. On Monday, GlaxoSmithKline, the maker of Avodart, asked the Food & Drug Administration (FDA) to approve the drug as a preventive treatment for men at high risk for prostate cancer.
Avodart is already approved to treat urinary problems, including enlarged prostate. It was approved by the FDA in 2002.
According to the Associated Press, the study that raised the heart risk association was designed to test Avodart as a prostate cancer preventive. It involved 6,700 men with high scores from PSA blood tests but no sign of cancer on biopsy who were treated either with Avodart or a placebo. Heart failure developed in 30 men on Avodart, compared to only 16 treated with placebo.
Prostate cancer was found in 25 percent of those placebo, compared with 20 percent of those on Avodart.
According to the Associated Press, the same reduction in prostate cancer has been seen with another drug, Proscar, sold generically as finasteride. However, a higher risk of heart failure has not been connected to Proscar.
GlaxoSmithKline acknowledged that the heart failure findings of the Avodart study were “unexpected.” However, the drug maker said the finding was inconsistent with other studies, and pointed out that further analysis suggests that men who developed heart failure while on Avodart also tended to be taking certain other drugs.
Dr. Otis Brawley, who helped run the study before becoming the American Cancer Society’s chief medical officer in 2007, told the Associated Press that while the finding of heart failure in the Avodart study could be a “fluke”, men treated with Avodart would need to be watched for it, and should stop taking the drug if it develops.