FDA Calls Two Ads by Abbott Misleading

Two of Abbott Laboratories Inc.’s ads for HIV-fighting drug Kaletra exaggerated benefits and left out information about life-threatening safety risks, U.S. regulators charged in a letter made public Tuesday.

The Food and Drug Administration ordered the company to stop circulating the ads immediately. One ran in POZ, a magazine aimed at people with the HIV virus. Another was posted in restrooms, the FDA said.

“These promotional pieces overstate the effectiveness of Kaletra and omit ... material information about the risks associated with Kaletra,” the FDA wrote in a letter that was dated Oct. 29 and posted on the agency’s website.

Officials at Abbott did not return calls seeking comment.

The FDA said both ads implied that Kaletra could help patients with HIV stay healthy for five years. HIV is the virus that causes AIDS.

Each ad featured pictures of a man looking healthy and captions indicating that the images were taken over a four- or five-year period. Text on the ads asked, “Where do you see yourself in five years?” and urged patients to discuss Kaletra with their doctors.

The ads were misleading because Kaletra was approved based on studies lasting 48 weeks and 72 weeks, the FDA said. “FDA is not aware of substantial evidence or substantial clinical experience to support claims of survival, good health, undetectable HIV [blood] levels and disease control for five years,” the agency said.

The ads also failed to mention potential side effects, which can include life-threatening interactions with other drugs, the FDA said. The promotions were reviewed as part of the FDA’s routine monitoring of drug advertisements, the agency said.