FDA cites promos from Astellas, Novartis and GSK

Three big drugmakers got warnings from the FDA for advertisements deemed misleading, the agency says. The letters to GlaxoSmithKline, Astellas Pharma, and Novartis concerned promotions for cancer, bladder and pain drugs.

The agency took issue with GSK because of an advertisement that didn't even mention a brand by name. According to that letter, the company left out "important information" about its cancer med Arzerra when it published an ad in a medical journal. The agency wasn't happy that GSK didn't include full safety and efficacy info, even though the ad didn't state Arzerra's name. It did include characteristics--such as specifics on its use--that could only describe Arzerra, FDA states, making it a "product-specific prescription drug ad for Arzerra."

In its warning to Novartis, FDA cites an "adherence" email sent to patients. That message understated the risks of using the arthritis topical gel Voltaren, the agency says, because risks are presented in fine print at the bottom of the email, while benefits were listed in a large, bold font, with colorful text and graphics, and ample white space around it. The risks should have been equally prominent and readable, the letter states.

Finally, the letter to Astellas (which was cc'd to GSK as promo partner). The warning cites a website for the bladder drug Vesicare, saying that it improperly compared Vesicare with another treatment for overactive bladder. Claims of superiority "must be supported by two ... head-to-head clinical trials," the agency says, so the site shouldn't have claimed that Vesicare was better than its rival.

- see the Arzerra letter from FDA
- check out the agency's Voltaren missive
- get the FDA warning about Vesicare's site
- read the story from Reuters