FDA Says Ads for Glaxo, Novartis Drugs Misleading

The U.S. Food and Drug Administration (FDA) has sent additional letters to drug makers regarding concerns it has with some <"http://www.yourlawyer.com/practice_areas/defective_drugs">drug marketing pieces, wrote the Wall Street Journal. An ad for a GlaxoSmithKline PLC cancer drug; a Web site for a bladder treatment Glaxo co-promotes, which the agency described as “false or misleading”; and a consumer email from Novartis AG concerning pain gel Voltaren are among the items at issue, said the Journal.

The FDA cited an ad from a medical journal about Glaxo’s drug Arzerra, which, said the FDA, omitted “important information about the drug’s safety and effectiveness,” quoted the Journal from the FDA’s letter to Glaxo. The letter was posted to the FDA’s site. Arzerra was approved in October and is a treatment of last resort for chronic lymphocytic leukemia, explained the Journal.

The advertisement, said the FDA, ran in December and neglected to discuss the risks linked to the drug, wrote the Journal, including “serious brain infection, pneumonia, fevers, and other blood disorders.” The FDA, discussing the Web address in the ad directing consumers to Arzerra’s prescribing information, does not minimize the “misleading omission of material information from the ad,” quoted the Journal.

In another letter released Friday, the FDA said a Web site for the drug Vesicare, co-promoted by GlaxoSmithKline and Astellas Pharma Inc., provided unproven overstatements abut the drug’s efficacy, said the Journal. Vesicare is approved for the treatment of overactive bladder. Another FDA letter on the site concerning Vesicare made claims that the drug is better for the treatment of incontinence over tolterodine, citing a comparison study, said the Journal. According to the FDA, the study’s data involved a “secondary study endpoint,” not a “main study goal,” thus sufficient information to confirm the claims was not supplied.

Regarding Novartis’ “adherence email” concerning Voltaren, an osteoarthritis pain relief gel, the FDA said the email “minimizes risks associated with the use of Voltaren Gel, overstates the efficacy of Voltaren Gel and broadens the indication for Voltaren Gel,” quoted the Journal. According to the agency, the email “prominently presents efficacy claims … in large bolded font size and in colorful text and graphics surrounded by a significant amount of white space” while “risk information is relegated to the bottom of the email … in single-spaced paragraph format that makes the information very difficult to read.”

Recently, other pharmaceutical firms were warned by the FDA about misleading promotions, said Reuters. In its letters, the FDA warned Gilead Sciences about its direct-to-consumer (DTC) print ads for Truvada, Gilead’s HIV medication, pointing to a “multiple-page ad” that suggested, “Truvada is better or more effective than has been demonstrated,” quoted Reuters.

The FDA also issued a warning to Biogen over its Web cast promoting Tysabri, a multiple sclerosis treatment, said Reuters. The video, said the agency in its letter, “is false or misleading because it minimizes important risks associated with the use of Tysabri and omits the drug’s approved indication,” quoted Reuters. “We are particularly concerned with this Web cast because it presents numerous statements that seriously minimize the risk of PML (progressive multifocal leukoencephalopathy),” the FDA added, pointing out that this is an established challenge.

The FDA, said Reuters, also issued the letter “privately” to Aton Pharma Inc. and sent a warning letter to Salix Pharmaceuticals.

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