FDA Policy/General

Toujeo TV Ad False, Misleading: OPDP

CDER’s Office of Prescription Drug Promotion (OPDP) says that a direct-to-consumer TV ad for Sanofi-Aventis’ Toujeo (insulin glargine injection) U-300, for subcutaneous use, makes false or misleading representations about the risks associated with the drug. A 12/12 Notice of Violation says the violation “is concerning from a public health perspective because it creates a misleading impression about the safety of Toujeo.”

Toujeo is indicated to improve glycemic control in adults with diabetes mellitus. It is not recommended for treating diabetic ketoacidosis. OPDP says the drug’s labeling contains Warnings and Precautions regarding sharing a Toujeo SoloStar Pen between patients, hyperglycemia or hypoglycemia with changes in insulin regimen, hypoglycemia, medication errors, hypersensitivity and allergic reactions, hypokalemia, and fluid retention and heart failure with concomitant use of PPAR-gamma agonists.

The letter says the ad communicates the major statement of serious risks through the audio and on-screen supers, but their presentation is diminished by use of compelling and attention-grabbing visuals and music that are unrelated to the risk message and compete for the viewer’s attention. “It is difficult for consumers to adequately process and comprehend the risk information,” OPDP says. “The overall effect undermines the communication of the important risk information and thereby misleadingly minimizes the risks associated with the use of Toujeo. The presentation in the video is especially problematic from a public health perspective given the serious and potentially life-threatening risks associated with the drug.”

Sanofi was told to stop using violative promotional materials and to respond with a list of materials containing the violations described and a plan for discontinuing their use.

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