FDA Issued an Untitled Letter to Pfizer for False or Misleading Video on Precedex

FDA sent the following untitled letter, dated 01/14/2016, to Pfizer.

NDA 021038
Precedex™ (dexmedetomidine hydrochloride) Injection
MA 268

As part of its routine monitoring and surveillance program, the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) has reviewed a video posted on the website YouTube.com titled, What to Expect: Hospira Precedex (dexmedetomidine HCl Injection) by Hospira, Inc. (Hospira) for Precedex™ (dexmedetomidine hydrochloride) injection (Precedex).

The video is false or misleading because it omits risks and material facts associated with Precedex. Thus, the video misbrands Precedex within the meaning of the Federal Food, Drug, and Cosmetic Act (FD&C
Act), and makes its distribution violative. 21 U.S.C. 352(a) & (n); 321(n); 331(a). See 21 CFR 202.1(e)(5). Hospira also did not comply with 314.81(b)(3)(i). These violations are concerning from a public health perspective because they create a misleading impression about the safety and effectiveness of Precedex.

According to its FDA-approved product labeling (PI), Precedex is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Precedex should be administered by continuous infusion not to exceed 24 hours. Precedex has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue Precedex prior to extubation. Precedex is also indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.

The PI for Precedex contains warnings and precautions regarding drug administration, hypotension, bradycardia, sinus arrest, transient hypertension, arousability, withdrawal, tolerance, tachyphylaxis, and hepatic impairment. The most common adverse reactions observed with Precedex are hypotension, bradycardia, and dry mouth.

Omission of Risk Information

Promotional materials are misleading if they fail to reveal facts that are material in light of representations made or with respect to consequences that may result from the use of the drug as recommended or suggested by the materials. The video contains numerous efficacy claims for Precedex, but fails to include risk information associated with the use of the drug. Furthermore, while the video alludes to arousability, this is presented as a benefit (i.e., what makes it “different” than other sedatives), 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.

Omission of Material Fact

Download “FDA Untitled Letter to Pfizer” UCM482464.pdf – Downloaded 199 times – 21 KB

Last Updated: 2016-01-20

Pfizer Hit with False and Misleading Video for Precedex
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