A national ad campaign for Roche's anti-obesity agent Xenical (orlistat) emphasizes the need to eat a diet with no more than 30% of calories from fat while taking the product. In addition to promoting a healthy diet, the ads are designed to reduce the possibility of side effects with the drug.

Developed by New York City-based Lowe and Partners, the ads note that side effects are more likely after meals containing more than 30% of calories from fat. "Since Xenical blocks about one-third of the fat in the food you eat, you may experience gas or oil with discharge, increased bowel movements, an urgent need to have bowel movements and an inability to control them, particularly after meals containing more fat than recommended."

"These symptoms are often temporary and may lessen or disappear as you continue treatment and keep to your recommended diet of meals containing no more than about 30% fat," the brief summary explains.

Both print and TV ads suggest eating reduced fat calorie meals with Xenical. The television spot shows a pizza while a voiceover states "No, you can't eat whatever you want." A plate with fish, rice, and vegetables is offered as an alternative.

Ads that ran in 12 major newspapers Sept. 30 explain "we do our best work after a good meal," which "is not a jumbo bucket of fried chicken." Ads will also run in Time, People and TV Guide in mid-October.

Xenical was approved April 23, but Roche has taken six months to roll out its DTC campaign. The delay may reflect difficulties in presenting unpleasant side effects along with the benefits of the products.

The advertisements were precleared by FDA. Side effect information is presented with a simple visual background. The agency has previously objected to DTC ads that have distracting music or images during the presentation of side effects and warnings.

The TV spots will begin running Oct. 4 during primetime television programming, including "Friends," "Monday Night Football" and "Barbara Walters." A "food lovers" TV ad will debut in late October, assuring customers that the Xenical program "does not mean total deprivation of the foods Americans like to eat," Roche said.

Roche Xenical DTC Ad Campaign Emphasizes 30% Fat Diet With Product

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