Novartis Cited for ‘Misleading’ Promotional Card

A promotional file card Novartis has put out is “misleading” and misbrands the company’s Alzheimer’s disease drug Exelon, “suggest[ing] that Exelon is safer or more effective than has been demonstrated,” according to a warning letter from the FDA’s Division of Drug Marketing, Advertising and Communications.

According to the Aug. 8 warning letter, posted to the FDA’s website Aug. 14, the file card “makes unsubstantiated superiority claims for Exelon, overstates the efficacy of Exelon, includes misleading risk presentations, and recommends or suggests a combination use of Exelon that has not been approved by FDA.”

Exelon (rivastigmine tartrate) is approved to treat mild-to-moderate Alzheimer’s disease, but is “associated with numerous risks,” such as gastrointestinal adverse reactions including nausea, vomiting and weight loss; anorexia, dyspepsia, asthenia, peptic ulcers and gastrointestinal bleeding; as well as effects on the cardiovascular, pulmonary and neurological systems (i.e., seizures), and risk of urinary obstruction, the warning letter said. The package insert also contains precautions for interactions with other drugs, and warns of potential problems if a patient is given anesthesia.

“Novartis takes all FDA letters seriously and is committed to working with the FDA to address their concerns,” Novartis spokeswoman Christine Cascio said. “We are currently reviewing the letter and will respond to the issues raised by the agency by Aug. 22, 2007. We will take the necessary steps to ensure that all of our promotional materials are in full compliance with FDA regulations.”

The warning letter can be accessed at www.fda.gov/cder/warn/2007/Exelon_wl.pdf.