Two Abbott HIV Drug Ads Misleading, U.S. FDA Says 

Reuters NewMedia - November 2, 2004 

WASHINGTON (Reuters) - Two Abbott Laboratories  Inc. promotions 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 on Tuesday. 

The Food and Drug Administration ordered the company to stop 

circulating the advertisements immediately. One ran in POZ, a magazine aimed at 

people with the HIV virus, and 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 Web site. 

Officials at Abbott did not immediately return calls seeking comment. 

The FDA said both promotions implied Kaletra could help patients with 

HIV, which causes AIDS, stay healthy for five years. 

Each ad featured pictures of a man looking healthy and captions 

indicating 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 maker advertisements, the agency said.