The U.S. Food and Drug Administration said a GlaxoSmithKline PLC (GSK) television advertisement for its Avodart prostate-shrinking drug last year was misleading because it overstated the drug's effectiveness.
In a warning letter to the U.K. drug giant posted on the agency's Website Thursday, the FDA said a 60-second spot titled "Planetarium" presented " misleading comparative claims and overstates the efficacy of Avodart." The drug, which had $738 million in worldwide sales last year, is approved to shrink enlarged prostates in men, and to improve associated symptoms and conditions such as urinary retention.
The commercial featured models of planets - including a big one and small one - meant to illustrate the shrinking of an enlarged prostate. An actor says in the ad that 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."
The FDA said the ad suggests that Avodart is the only medication that shrinks the prostate, but this isn't the case. The agency says Merck & Co.'s (MRK) Proscar, which is also available from generic manufacturers, reduces prostate volume.
Also, the FDA said there was nothing in Avodart's prescribing label to suggest any specific advantages over other products. The agency isn't aware of any comparative clinical trials to support Glaxo's claim that Avodart is superior.
The FDA has asked Glaxo to immediately stop dissemination of these types of promotional materials.
GlaxoSmithKline spokeswoman Sarah Alspach said the ad ran from March to September of 2008, and won't be aired in the future.
"GlaxoSmithKline is committed to responsible marketing of our medicines," she said. "We are making every effort to ensure that future advertising for Avodart integrates the direction provided to us by the FDA."
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