FDA Says Glaxo Prostate Drug Ad Misleads

Updated from 12:57 p.m. EST

The Food and Drug Administration has admonished GlaxoSmithKline(GSK Quote), 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 Quote) 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.