FDA Cites Kowa Pharma DTC Video

CDER’s Office of Prescription Drug Promotion (OPDP) has cited a Kowa Pharmaceuticals America direct-to-consumer patient testimonial video montage YouTube video about cholesterol-lowering Livalo (pitavastatin) because it makes false or misleading representations about the drug’s risks. A just-posted OPDP untitled letter says the video “misleadingly suggests that Livalo is safer than its competitors by implying that patients switching to Livalo from other statins will experience a reduction in side effects compared to other statins, or no side effects at all.” It also says the video is misleading because it fails to present information relating to contraindications, warnings, precautions and adverse reactions “with a prominence and readability reasonably comparable with the presentation of information relating to the benefits of Livalo.” OPDP requested that Kowa stop running the videos because of the violations.