WASHINGTON (Reuters) - A Pfizer Inc. advertisement for Geodon omitted important risk information and contained unsupported claims that the schizophrenia drug was better than another drug, U.S. regulators said in a letter released on Monday.
The Food and Drug Administration asked Pfizer to stop running the ad, which appeared in a medical journal. The agency's letter to Pfizer was dated July 16 but posted on the FDA Web site on Monday.
The FDA said the Pfizer ad included some information about potential side effects from injectable Geodon but failed to list "other serious warnings and precautions." Specifically, the promotion failed to mention the possibility of neuroleptic malignant syndrome, tardive dyskinesia, hyperglycemia and diabetes.
In addition, the ad implied Geodon was more effective than a generic drug, haloperidol, "when this has not been demonstrated by substantial evidence or substantial clinical experience," the FDA said.
"This piece is false or misleading because it omits important risk information and contains unsubstantiated superiority claims," the FDA letter said.
A Pfizer spokeswoman could not immediately be reached for comment.
The FDA letter was posted at:
