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Novartis warned on Exelon promotion for Alzheimerís disease

Novartis' promotion for mild-to-moderate Alzheimer's disease drug Exelon has made misleading claims about the medicine's effectiveness and risks, warns the FDA

Swiss-based pharmaceutical company Novartis' promotion for mild-to-moderate Alzheimer's drug Exelon (rivastigmine) has made misleading claims about the medicine's effectiveness and risks, according to FDA officials.

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

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

The FDA said the Novartis file card exaggerated Exelon's benefits and suggested its use with another Alzheimer's drug, Forest Laboratories' Namenda (memantine), a combination which is not approved by the agency.

The FDA added that various presentations of the drug's safety were misleading. One section titled "Safety Profile" failed to mention serious risks including gastrointestinal reactions. Global FY06 sales of Exelon were USD 525m.

The FDA letter can be found on the FDA website: http://www.fda.gov/cder/warn/2007/Exelon_wl.pdf

15th August 2007

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