Another Kardashian FDA letter: Biohaven smacked for Khloe's Nurtec migraine med claims

Biohaven Nurtec ODT spokesperson Khloe Kardashian
The FDA sent Biohaven an untitled letter this week over its celebrity spokesperson Khloe Kardashian TV talk show appearance last year for Nurtec. (Biohaven)

Reality star Khloe Kardashian’s appearance on "The View" talk show earned Biohaven Pharmaceuticals loads of media impressions and mentions last summer—but now it's earned the pharma company an FDA slapdown.

Kardashian appeared on the morning talk show last July just after she signed on as a Nurtec spokescelebrity. During the seven-minute segment, she talked about her daughter, her family’s reality series and her migraine headaches.

All fine so far. But she also called Nurtec ODT a “game changer,” claimed it works in 15-20 minutes and said it doesn’t give her rebound headaches like the other migraine meds she’s used. All while being recognized as a paid spokesperson for Biohaven and Nurtec.

Kardashian’s claims are false or misleading on efficacy and on risks, the FDA's Office of Prescription Drug Promotion (OPDP) wrote in the untitled letter issued Tuesday.

Biohaven acknowledged the FDA letter in a statement and added it is "working closely with the FDA to evaluate and respond.”

RELATED: Biohaven hits social media jackpot with superceleb Khloe Kardashian as spokesperson for migraine med Nurtec

Along with Kardashian’s casual superlatives overstating efficacy, the OPDP pointed out that risk information is mostly missing from the segment. While the audio and video highlight Kardashian’s benefit claims, the risks are reduced to text only and in a small font size.

Instead of the typical laundry list of potential risks in TV ads, "The View" interview ends simply with host Whoopi Goldberg thanking Kardashian for being on the show to talk about migraine, asks her to repeat the drug name once more and then ends the segment saying, “We’ll be right back.” The segment is still available on the show's YouTube channel.

The untitled letter maintains that “the overall effect of disclosing risk information in this manner undermines the communication of risk information and thereby misleadingly minimizes the risks associated with the use of Nurtec ODT."

The watchdog further dinged Nurtec for failing to file the required Form FDA-2253 before the segment aired. The form and promotion submission is a required FDA filing for any drug advertising or promotion before its use. The OPDP said it reviewed the video interview on its own but also received one complaint through the FDA’s Bad Ad snitch program.

RELATED: Biohaven accelerates DTC campaign timing for migraine med Nurtec

Khloe Kardashian joins sister Kim Kardashian in the bad ad doghouse in what's likely a first for family members receiving FDA promo reprimands. Kim was warned back in 2015 when she served as a spokesperson for Duchesnay morning sickness drug Diclegis. She posted an Instagram rave without an #ad label and with few risk details, but included a link to the drug’s website. Her post was captioned “OMG. Have you heard about this?” The FDA forced Duchesnay and Kim Kardashian to run another post listing all the risks.

The FDA did not delineate what if any action it may require Biohaven to take, only warning the pharma that it has 15 days to detail its response and explain its plans to discontinue the video’s use.

Khloe Kardashian, a social media star with more than 133 million followers on Instagram, signed on as a Biohaven Nurtec ambassador in July—and "The View" was one stop on her media day introductory tour. Khloe is currently featured in Nurtec branded TV ads running nationally and on the Nurtec website as part of Biohaven’s Take Back Today campaign.