The FDA demanded that Jazz Pharmaceuticals halt dissemination of a patient brochure for Luvox CR and run corrective messages to counter inflated benefit claims and omission of risk information.
In a warning letter dated July 6, DDMAC lashed Jazz for a patient brochure promoting the drug, which carries a boxed warning, for the treatment of seasonal affective disorder and obsessive-compulsive disorder.
The brochure, said FDA, omits important warning information, and thereby “misleadingly suggests that Luvox CR is safer than has been demonstrated.” Risk information, including that from the boxed warning, is absent from two multi-page profiles included in the brochure.
“Furthermore, while the rest of the information in the patient brochure is presented in consumer-friendly language,” said the warning letter, the risk information that is included “is presented in medical terminology that is not likely to be understood by consumer audiences.” The agency deemed unsatisfactory a line at the bottom of the page urging readers to “see accompanying full prescribing information, including boxed warning.”
Asked what form corrective messaging might take, an agency spokesperson said FDA “has requested that the company distribute corrective messages targeted to the audience exposed to the misleading promotion contained in the patient brochure and will work with the company.”