FDA calls out Kardashian drug promo video for false claims
The FDA is clearly keeping up with the Kardashians as its Office of Prescription Drug Promotion (OPDP) raised concerns that Khloé Kardashian’s promotional video for a Biohaven Pharmaceuticals migraine drug made false claims about quick relief in as little as 15 minutes.
In reality, OPDP said in its first untitled letter of the year, clinical work to support the drug, known as Nurtec ODT, began measuring how it works two hours after dosing.
“Claims that Nurtec ODT provides relief in 15-30 minutes are not supported by the clinical trial data,” the FDA said in its letter released Tuesday.
The video, which originally aired on ABC’s “The View” last summer, also claims that Nurtec ODT is more effective than other migraine drugs and a “gamechanger.”
Again, the FDA makes clear that these comparative claims are misleading because Biohaven has not demonstrated that Nurtec ODT is clinically superior to or more effective than other prescription and over-the-counter drugs. The company has 15 working days to respond to the FDA.
“Biohaven is working closely with the FDA to evaluate their comments and respond,” the company said in an SEC filing on Tuesday.
This isn’t the first run-in between the FDA and the Kardashians over their promotion of drugs. Khloé’s sister Kim promoted Duchesnay’s morning sickness drug Diclegis on Instagram back in 2015 and the FDA slammed the company with a warning letter for not disclosing enough risk information in the post.