FDA Chides Glaxo for Cancer-Drug Ad

The Food and Drug Administration on Friday said an advertisement for a GlaxoSmithKline PLC cancer drug and a Web site for a bladder treatment the company co-promotes were "false or misleading."

The agency also took issue with a consumer email from Novartis AG about its pain gel Voltaren.

Specifically, an advertisement that ran in a cancer medical journal involving Glaxo's drug Arzerra omitted "important information about the drug's safety and effectiveness," the FDA said in a letter to the company that was posted on the agency's Web site. Arzerra was approved in October to treat chronic lymphocytic leukemia after other therapies fail.

The agency said the ad, which ran in December, failed to reveal any risks associated with the product, including a serious brain infection, pneumonia, fevers and other blood disorders. The agency said a Web-site address provided in the ad that directed people to all the prescribing information for Arzerra doesn't mitigate the "misleading omission of material information from the ad."

Mary Anne Rhyne, a Glaxo spokeswoman, said the Arzerra ad referenced by the FDA won't be used again.

"We are working to resolve any remaining questions and ensure our materials reflect the direction provided by the FDA," she said.

In another letter released Friday, the FDA said a Web site for the drug Vesicare, which is co-promoted in the U.S. by GlaxoSmithKline, of Brentford, England, and Japan's Astellas Pharma Inc., presented unsubstantiated superiority claims and overstated the effectiveness of the product. Vesicare is approved to treat a condition known as overactive bladder.

The agency said information on the Web site suggested Vesicare was better than another drug, tolterodine, at improving incontinence, by citing a study comparing the products. The FDA said the information used to make a superiority claim involved a secondary study endpoint, rather than a main study goal, and doesn't provide enough evidence to suggest Vesicare is better than the other drug.

Both Astellas and GlaxoSmithKline said the Vesicare Web site has been changed to remove the content the FDA was concerned about.

The FDA said a so-called "adherence email" sent by Novartis involving Voltaren, a gel applied to the knees or hands for osteoarthritis pain, "minimizes risks associated with the use of Voltaren Gel, overstates the efficacy of Voltaren Gel and broadens the indication for Voltaren Gel."

The agency said the email "prominently presents efficacy claims" or effectiveness information "in large bolded font size and in colorful text and graphics surrounded by a significant amount of white space" while the "risk information is relegated to the bottom of the email...in single-spaced paragraph format that makes the information very difficult to read."

In a statement, a Novartis spokeswoman said the Swiss company was reviewing the letter it received from the FDA. "We plan to work with the FDA to address concerns," she said.

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