FDA: GSK’s Avodart ads misleading

Consumer ads in support of GlaxoSmithKline’s prostate drug Avodart overstate its efficacy and present misleading claims, the FDA said in a letter to the company.

The ad in question—a 60-second TV spot titled Planetarium—depicts artists working on planetary models, with one artist having to leave for the bathroom. Afterward, the actor recounts a conversation with his doctor: “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 TV ad misleadingly suggests that Avodart is superior to other drug therapies when this has not been demonstrated by substantial evidence or substantial clinical experience,” DDMAC’s Cynthia Collins, consumer safety officer, said in the letter, citing Merck’s Proscar, another drug approved for the treatment of symptomatic benign prostatic hyperplasia.

FDA also took issue with a graphic showing a large planet and a small planet. “The visual of the planet shrinking in size represents a reduction in prostate volume that is much greater than the reduction actually achieved with Avodart therapy in clinical trials,” the letter said. “In fact, the approximately 20-25% reduction in volume corresponds to a difference in diameter of less than 10%.”

The untitled letter requested that GSK immediately cease dissemination of the ad, and submit a written response to the letter by March 4.