FDA Says Avodart Ad is Misleading

The Food and Drug Administration has pulled the plug on a television advertisement for the prostate drug Avodart, which the agency said makes untrue and misleading claims about the advantages and effectiveness of the drug.

The ad includes a false statement about Avodart being the only drug in its class to reduce the size of the prostate when other drugs have the same effect, according to the FDA. The agency sent a letter to the drug’s maker, GlaxoSmithKline, on February 18, 2009, ordering the ad off the air and giving the company until March 4, 2009 to respond to the concerns.

About 50 percent of men over 50 and 90 percent of men over 80 in the United States suffer from an enlarged prostate, which can cause frequent urination, difficulty urinating, and other complications. Avodart is a leading drug in the treatment of an enlarged prostate.

Misleading Claim in Ad

The Avodart ad in question features a male actor working on a model of the solar system. The man is forced to stop painting on the model due to frequent trips to the bathroom before a colleague recommends he take Avodart for his symptoms.

Specifically, the FDA took exception to the statement in the ad saying that Avodart is different from other prostate drugs because “other medicines, they don’t treat the cause, because they don’t shrink the prostate.”

That is not true, according to the FDA. Another drug made by Merck & Co., called Proscar, also reduces the size of the prostate and is approved for the same treatment as Avodart, officials said. There is nothing to suggest that Avodart is more effective than Proscar or that only Avodart reduces the size of an enlarged prostate, according to the FDA.

Other Problems Noted

The FDA also raised a red flag on the ad’s use of visual aids to promote Avodart’s ability to shrink enlarged prostates. During the ad, a man holds up a model of a planet then replaces it with a much smaller planet to illustrate Avodart’s prostate-shrinking power.

The FDA said the use of those images overstates the documented effects of Avodart, which has been shown to reduce the prostates size about 25 percent after two years.

A Glaxo spokesperson said the company remains committed to producing responsible marketing and noted that the ad in question has not aired since the fall of 2008.

Avodart was approved for use in the United States in 2001 and has emerged as a leading seller for Glaxo, the world’s second-largest drug company which has its U.S. headquarters in Research Triangle Park, N.C.

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