Pharmaceutical company, Novartis, produces Exelon that is used in the treatment of Alzheimer’s disease. A recent Exelon promotional brochure distributed to health-care professionals has caught the eye of the FDA because it is thought to be misleading.
The FDA faxed a warning to Novartis that states that Exelon is associated with numerous risks and that Novartis overstates the efficacy of Exelon, includes misleading risk presentations, and recommends or suggests a combination use of Exelon that has not been approved by the FDA. From a public health perspective these violations suggest that Exelon is safer or more effective than has been demonstrated. Novartis has also encouraged the use of Exelon in circumstances other than those for which the drug has been shown to be safe and effective.
Novartis is expected to respond to the FDA warning by August 22.