FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Kowa Pharmaceuticals Rapped for Misleading YouTube Video

Oct. 14, 2019
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The FDA’s Office of Prescription Drug Promotion (OPDP) issued an untitled letter to Kowa Pharmaceuticals for a video that makes false and misleading claims for its high cholesterol drug Livalo (pitavastatin).

The montage, posted to YouTube, featured three testimonials from patients that suggested switching to the drug from other statins lowered their cholesterol and that they did not experience any side effects.

The agency deemed the testimonials misleading because, while they may accurately reflect the patient’s personal experiences, they do not “adequately support the suggestion in the presentation that other patients switching to Livalo from other statins will experience a similar reduction in side effects compared to other statins, or no side effects at all.”

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