Oxtellar Opinion Leader Video Misbrands Drug: OPDP
The CDER Office of Prescription Drug Promotion (OPDP) that a Spanish-language video produced by Supernus Pharmaceuticals to influence key opinion leaders about its Oxtellar XR (oxcarbazepine) extended-release tablet for oral use makes false or misleading claims about the drug’s risks and provides evidence that it is intended for a new unapproved use, misbranding the drug. A 10/31 Notice of Violation says the “violations are concerning from a public health perspective because they create a misleading impression about the safety and effectiveness of Oxtellar XR and suggest a use for which the labeling does not provide adequate directions for the safe and effective use of the product.”
Oxtellar XR is indicated for adjunctive therapy of partial seizures in adults and children ages 6 to 17. The labeling says it is associated with serious risks, including hyponatremia, anaphylactic reactions and angioedema, hypersensitivity reactions in patients with hypersensitivity to carbamazepine, serious dermatologic reactions, suicidal behavior and ideation, withdrawal of anti-epileptic drugs, multi-organ hypersensitivity, hematologic reactions, risk of seizures in pregnant women, and changes in laboratory tests.
The letter says that statements in the video about using the drug when epilepsy is not controlled or improving the level of convulsive control suggest that Oxtellar XR is intended for use in treating epilepsy, including seizure types other than partial seizures. “Therefore, the video presentation provides evidence that Oxtellar XR is intended for use in treating all seizure types, which is a use for which it lacks approval and for which its labeling does not provide adequate directions,” it says. It says that presenting the correct indication in a scrolling text and voiceover was not sufficient to negate the earlier statements.
In addition, OPDP says, the video opens with a presentation of benefit claims but no specific risks. “The presentation of risks associated with Oxtellar XR is relegated to the end of the video…, where it is unlikely to draw the viewer’s attention, as it is displayed in scrolling text with a voiceover,” the notice says. “This overall presentation misleadingly minimizes the risks associated with Oxtellar XR because it fails to convey risk information with a prominence reasonably comparable to the claims of effectiveness. 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.”
Supernus was told to stop violating the Federal Food, Drug, and Cosmetic Act in the ways described in the letter and to reply with a list of Oxtellar XR promotional materials that contain such violations and a plan for discontinuing their use.