Avodart as Prostate Cancer Preventer Prompts Skepticism at FDA

The maker of <"http://www.yourlawyer.com/practice_areas/defective_drugs">Avodart wants to market the drug as a way to reduce prostate cancer risks in certain men, but according to a report in The Wall Street Journal, the Food & Drug Administration (FDA) is questioning the clinical benefits of using Avodart in this way. An FDA outside advisory panel is scheduled to discuss expanded use of Avodart tomorrow.

Avodart was first approved by the FDA in 2002 to treat urinary problems, including enlarged prostate. Glaxo asked the FDA to allow expanded marketing of the drug this past March.

According to The Wall Street Journal, a Glaxo-funded study called the REDUCE trial, which involved more than 8,000 men considered at high risk of developing prostate cancer, found a 23 percent reduction in the risk of developing prostate cancer over a four-year period among those treated with Avodart, compared to patients receiving a placebo. However, a document posted on the FDA website yesterday said the study results involving Avodart “do not appear to confer clinical benefit for the indication under consideration.”

According to those documents, the risk reduction seen in the Glaxo Avodart study was driven by prostate cancers considered to be low-risk. Additionally, the FDA said there was an increase in high risk, or more aggressive, prostate cancers. Specifically, 29 high-grade tumors were found among patients being treated with Avodart compared to 19 in the placebo group, the Journal said.

The REDUCE trial also pointed to another possible obstacle to Avodart’s expanded approval. In the study, men receiving Avodart had an increased incidence of heart failure (30 events or 0.7 percent) compared to men receiving placebo (16 events or 0.4 percent).

In March, Glaxo acknowledged that the heart failure findings of the REDUCE 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 at the time 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.

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