Pfizer, Hospira, Get FDA Warning Letter Over Precedex YouTube Ad

Federal drug regulators are warning Pfizer and its recently acquired Hospira subsidiary that a YouTube ad promoting the sedative Precedex may violate drug marketing laws, by omitting important risk information for patients. 

The FDA issued a warning letter to Hospira and Pfizer on January 14, indicating that a video posted on YouTube titled “What to Expect: Hospira Precedex (dexmedetomidine HCl Injection)” has been deemed to be false or misleading.

According to the agnecy, the video fails to include risk information, and does not make the FDA’s approved intended use clear.

“The video contains numerous efficacy claims for Precedex, but fails to include risk information associated with the use of the drug,” the warning letter states. “Furthermore, while the video alludes to arousability, this is presented as a benefit…instead of a warning and precaution. 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.”

Precedex (dexmedetomidine hydrochloride) is a sedative given to patients via who have been intubated or are on mechanical ventilators in intensive care. It is administered via infusion for no more than 24 hours. It was first approved as a Hospira drug by the FDA in 1999.

The FDA warning letter says that while the video says Precedex is used in an intensive care setting, it does not inform the viewer about the limitations on that usage.

However, Pfizer officials told FiercePharma.com that the video was never intended for public viewing outside of the Precedex website. Company officials say that the video was originally meant to stay on that website, which contained all of the warning and indication information the FDA required.

The company says the video was taken down from the Precedex page after Pfizer bought Hospira in September and conducted a review of its internet marketing materials. They began efforts to take the video off of YouTube on January 15 and say they are in the process of reviewing and developing a response to the FDA letter.