Healthy Skepticism Library item: 11197

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

U.S. warns Novartis on Alzheimer's drug promotion
Reuters 2007 Aug 14
http://www.reuters.com/article/healthNews/idUSN1444898320070815

Notes:

Link to FDA letter:
http://www.fda.gov/cder/warn/2007/Exelon_wl.pdf
Link to promotional material:
http://www.fda.gov/CDER/warn/2007/Exelon_promo.pdf

Full text:

WASHINGTON (Reuters) – A Novartis AG promotion for Alzheimer’s drug Exelon made misleading claims about the medicine’s effectiveness and risks, U.S. health officials warned the company in a letter released on Tuesday.

The claims appeared on a file card written for health-care professionals about Exelon capsules and oral solution, the Food and Drug Administration said. The agency asked Novartis to stop using the material and to circulate new information to correct misleading statements.

“These violations are concerning from a public health perspective because they suggest that Exelon is safer or more effective than has been demonstrated, and they encourage the use of Exelon in circumstances other than those for which the drug has been shown to be safe and effective,” the FDA said in a letter dated August 8.

Novartis spokeswoman Christine Cascio said the company was reviewing the FDA letter and would respond by August 22 as the agency requested.

“We will take the necessary steps to ensure that all of our promotional materials are in full compliance with FDA regulations,” Cascio said in an e-mail.

Exelon, known generically as rivastigmine, is approved to treat mild to moderate dementia seen in Alzheimer’s disease.

The FDA said the Novartis file card overstated Exelon’s benefits and suggested its use with another Alzheimer’s drug, Forest Laboratories Inc’s Namenda. That combination is not FDA-approved.

In addition, the agency said various presentations of the drug’s safety were misleading. One section titled “safety profile” failed to mention serious risks including gastrointestinal reactions.

The FDA letter referred to a promotion for Exelon capsules and oral solution. Novartis also sells an Exelon patch.

Exelon sales were $525 million worldwide in 2006.

The FDA letter was posted on the agency Web site on Tuesday at http://www.fda.gov/cder/warn/2007/Exelon_wl.pdf.

Novartis shares fell 1.4 percent to close at $52.83 on the New York Stock Exchange.