FDA Policy/General

Hospira Precedex Video ‘False and Misleading’: OPDP

CDER’s Office of Prescription Drug Promotion (OPDP) says that a Hospira YouTube video for its Precedex (dexmedetomidine HCl) injection is false and misleading because it omits risks and material facts associated with the drug. A 1/14 Notice of Violation says the violations create “a misleading impression about the safety and effectiveness of Precedex.”

Precedex is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. It is to be administered by continuous infusion not to exceed 24 hours. It also is indicated for sedation of non-intubated patients before and/or during surgical and other procedures.

The letter says the video contains numerous efficacy claims for Precedex, but fails to include risk information associated with its use. Also, OPDP says, while the video alludes to arousability, it is presented as a benefit that differentiates Precedex from other sedatives, rather than as 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 use of the drug and creates a misleading impression about the drug’s safety,” the letter says.

OPDP also says that Hospira failed to submit the video to the agency at the time of initial dissemination as required by regulations.

Hospira was told to stop distributing violative promotional materials for Precedex and to respond with a list of materials containing the violations cited in the letter and a plan for discontinuing their use.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome