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By Bronwyn Mixter
Jan. 20 — A video for the sedative Precedex (dexmedetomidine hydrochloride injection) is false or misleading because it omits important risk information, the FDA said in a letter posted online recently.
The Jan. 14 untitled letter, sent to Hospira Inc. in Lake Forest Ill., said the Food and Drug Administration's Office of Prescription Drug Promotion (OPDP) reviewed a video posted on YouTube for Precedex. The agency said the video misbrands Precedex under the Federal Food, Drug and Cosmetic Act.
An untitled letter cites violations that don't meet the threshold of regulatory significance for a warning letter, according to the agency's regulatory procedures manual.
Precedex is indicated for the sedation of initially intubated and mechanically ventilated patients during treatment in intensive care. It also is indicated for sedation of nonintubated patients before or during surgical and other procedures.
The FDA said the prescribing information for Precedex “contains warnings and precautions regarding drug administration, hypotension, bradycardia, sinus arrest, transient hypertension, arousability, withdrawal, tolerance, tachypylaxis and hepatic impairment.”
The FDA said the video contains several efficacy claims for Precedex but fails to include any risk information.
“By omitting the risks associated with Precedex, the video fails to provide material information about the consequences that may result from the use of the drug and creates a misleading impression about the drug's safety,” the letter said.
The agency also said the video “makes representations about the use of Precedex for intensive care unit sedation, but it is misleading because it fails to communicate material information regarding the FDA-approved indication for Precedex.”
The FDA also said the company didn't submit a copy of the video to the agency as required.
The FDA asked Hospira to stop using the video and submit a response to the letter.
“The violations discussed in this letter do not necessarily constitute an exhaustive list,” the agency said. “It is your responsibility to ensure that your promotional materials for Precedex comply with each applicable requirement of the FD&C Act and FDA implementing regulations.”
The letter was signed by Jessica M. Fox, an OPDP regulatory review officer. It also was signed by Samuel M. Skariah, an OPDP team leader.
The YouTube video has been removed. The company couldn't be reached for comment on the letter.
Hospira is part of New York-based Pfizer Inc.
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