Are the FDA's marketing specialists growing harder noses? First, Pfizer was scolded for its "misleading" Geodon advertising. Now, the FDA is shaking its finger at Novartis over promotional materials that claim its Alzheimer's drug Exelon is more efficacious than Pfizer's Aricept, and downplays its side effects, too. The FDA questions both claims and demands that Novartis stop using the materials, which are targeted at healthcare professionals.
In Pfizer's case, the FDA questioned a medical journal ad that left out the potential for serious side effects--such as diabetes and neurological disorders--from Geodon, a schizophrenia remedy. The company also claimed Geodon is better than competitor Haloperidol IM, but the FDA says neither evidence nor clinical experience has proven so. Both companies say they'll comply with the FDA's orders.
- check out the warning letter for Exelon
- read the report from PharmaTimes
- and here's the report from CNN
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