FDA slams Pfizer subsidiary for "misleading" Precedex video
The FDA's Office of Prescription Drug Promotion requested Hospira submit a written response by January 29.
This story has been updated.
The FDA's Office of Prescription Drug Promotion slammed Pfizer subsidiary Hospira over a YouTube video titled “What to Expect: Hospira Precedex.”
In an untitled letter, the FDA said the video was misleading as it omitted information about risks associated with the drug. Information, such as the sedative's arousability, was “presented as a benefit…instead of a warning and precaution."
The video explains Precedex's use as a sedative in the intensive care setting but failed to convey the indications and usage section of its FDA-approved label, according to the FDA.
The regulator demanded Hospira submit a written response by January 29. Hospira has since taken down the YouTube video.
Pfizer closed its acquisition of injectable drugmaker Hospira for $17 billion in September.
"Although the video was not accessible to the public, further steps have been taken to remove the cited content from the Hospira YouTube channel as of Jan. 15, 2016," Pfizer said in a statement. "Hospira is in the process of reviewing and responding to the OPDP letter."