Healthy Skepticism Library item: 11213

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

FDA warns Novartis over misleading information on Exelon
Pharma Times 2007 Aug 15
http://www.pharmatimes.com/WorldNews/ViewArticle.aspx?id=11523

Full text:

Days after Pfizer got a slap on the wrist for the way it advertised the schizophrenia drug Geodon, Novartis is the latest pharmaceutical giant to be warned by US regulators about the way it promotes one of its drugs, in this case the Alzheimer’s treatment Exelon.

The US Food and Drug Administration has written to the Swiss firm about a file card written for healthcare professionals that promotes Exelon (rivastigmine), and the agency’s Division of Drug Marketing, Advertising, and Communications says the promotional material used by the firm gives “misleading” information about the effectiveness and approved uses of the drug, which is indicated for the treatment of mild to moderate dementia caused by Alzheimer’s disease.

The first criticism the DDMAC has about the file card is that it makes several unsubstantiated superiority claims comparing the efficacy of Exelon to Pfizer/Eisai’s Aricept (donepezil). The card states that “70% of donepezil nonresponders responded to Exelon” but this claim is based on a 26-week, open-label, single-arm, uncontrolled trial of Novartis’ drug, a study which was “inadequate in several respects”.

The FDA also says that the card overstates efficacy and is also misleading because it suggests that Exelon is safer than has been demonstrated by “substantial clinical evidence”. The agency notes that the drug is associated with “significant gastrointestinal adverse reactions relative to placebo”, including nausea, vomiting, weight loss and anorexia.

Novartis is also accused of a “lack of adequate directions for use” as the card also suggests benefits to be obtaining through combining Exelon with another Alzheimer’s drug, Forest Laboratories’ Namenda (memantine). However that combination has not been proven to be safe and effective, says the DDMAC, which adds that “in fact, they are not indicated for the same patient populations”. Namenda is used to treat moderate to severe dementia in Alzheimer’s patients.

The DDMAC requested that Novartis “immediately cease the dissemination of violative promotional materials” and a spokeswoman for the company said would respond to the letter by August 22 as requested. She added that “we will take the necessary steps to ensure that all of our promotional materials are in full compliance with FDA regulations”.