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# TV Spot Creates Otezla Misleading Safety Impression: OPDP
- URL: https://www.fdaweb.com/tv-spot-creates-otezla-misleading-safety-impression-opdp/
- Published: 2016-12-14T12:00:00.000Z
- Updated: 2026-09-14T21:54:58.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137574

CDER’s Office of Prescription Drug Promotion (OPDP) says that a TV spot for Celgene’s Otezla (apremilast) makes false or misleading representations about the drug’s risks and is concerning from a public health perspective by creating a misleading impression about the drug’s safety. A 12/12 [Notice of Violation](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM533292.pdf?ref=fdaweb.com) says Otezla is indicated for treating adult patients with active psoriatic arthritis and for treating patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

The labeling contains Warnings and Precautions about depression, weight decrease, and drug interactions, OPDP says. The most common adverse reactions associated with Otezla are diarrhea, nausea, upper respiratory tract infection, and headache, including tension headache.

The letter says that the presentation of compelling and attention-grabbing visuals and supers, all of which are unrelated to the risk message carried in the audio, in addition to frequent scene changes and other competing modalities such as musical interjections, compete for the consumer’s attention. “As a result,” it says, “it is difficult for consumers to adequately process and comprehend the risk information. The overall effect undermines the communication of the important risk information and thereby misleadingly minimizes the risks associated with the use of Otezla.”

Celgene was told to stop using violative promotional materials and to respond with a list of materials containing violations such as those described in the notice and a plan for discontinuing their use.