FDA Says Glaxo Prostate Drug Ad Misleads

The FDA says an ad for Glaxo's prostate drug Avodart makes false statements
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Updated from 12:57 p.m. EST

The Food and Drug Administration has admonished

GlaxoSmithKline

(GSK) - Get Report

, calling an ad for its prostate drug Avodart misleading.

In a letter to Glaxo dated Feb. 18, the FDA said a television ad for Avodart -- used to treat symptoms of enlarged prostates such as frequent urination -- makes false claims.

In the ad, a man tells his peer: "Avodart is different because over time it actually shrinks the prostate, so I go less often. Other medicines, they don't treat the cause, because they don't shrink the prostate."

Not so fast, said the FDA. "The TV ad clearly suggests that Avodart is the only medication that shrinks the prostate, when this is not the case," the agency wrote in its

letter

to Glaxo. The agency pointed out that

Merck

's

(MRK) - Get Report

Proscar, another drug approved to treat symptoms of benign prostatic hyperplasia, also reduces prostate volume. "Therefore, the claim, 'Other medicines . . . don't shrink the prostate' is misleading," the FDA wrote.

The FDA also said the ad uses visual cues to exaggerate the degree to which Avodart shrinks the prostate. The man in the ad, who is assembling a model of the solar system, holds a larger planet and a smaller planet, ostensibly representing his prostate. This "overstates the efficacy of Avodart by showing a degree of reduction in prostate volume due to treatment with Avodart that has not been demonstrated by substantial evidence or substantial clinical experience," the FDA wrote.

In the letter, the FDA asked Glaxo to "immediately cease the dissemination of violative promotional materials for Avodart" and respond by March 4.

Glaxo said in a statement Friday that the ad has not aired since last fall, and that the company "is committed to responsible marketing," according to

The Associated Press

.

Glaxo shares closed down 0.2% to $30.13.