FDA lashes out at drug company for promoting Canadian morning-sickness pill on Kardashian Instagram feed

American authorities have sharply rebuked a Canadian drug company over its part in an unusual melding of celebrity culture, social media and pharmaceutical marketing.

An post by extoling the benefits of the firm’s morning-sickness drug was false or misleading and “misbranded” the pills, said the U.S. Food and Drug Administration in a warning letter disclosed Tuesday.

The post – which mentioned that Kardashian was partnering with Quebec-based Duchesnay Inc. – focused on the benefits of Diclectin and mentioned nothing of its risks, the FDA noted.

The infraction is “particularly troubling,” given Duchesnay was chastized for similar problems in a promotional letter it sent doctors in late 2013, the caution said.

The agency demanded the firm find a way to convey risk information to the same, huge audience that had access to the reality-TV star’s original message. Kardashian boasts 47 million Instagram followers, and more than 460,000 likes for her post on the drug, known as Diclegis in the U.S.

‘OMG. Have you heard about this?’

“Because the violations described … are serious and repeated, we request further that your submission include a comprehensive plan of action to disseminate truthful, non-misleading and complete corrective messages,” the warning said. “These violations are concerning from a public perspective because they suggest that Diclegis is safer than has been demonstrated.”

The Kardashian post on the drug appeared to have been removed from Instagram on Tuesday.

Laney Landsman, a spokesman for Duchesnay USA, said the firm will work with the regulator to come up with a way to meet its requests.

“We will take quick action in responding to the FDA’s letter and immediately and effectively address any issues,” he said in an email response to questions. “We appreciate the FDA’s objective of ensuring that promotions remain consistent with approved labeling.”

Kardashian, carrying her second child with husband Kanye West, said three weeks ago on the photo-sharing site that she had tried changing her diet and lifestyle to deal with persistent nausea and vomiting. But nothing worked until her doctor prescribed Diclegis.

THE CANADIAN PRESS/Mark BlinchTHE CANADIAN PRESS/Mark BlinchKanye West performs during the closing ceremony at the Pan Am Games in Toronto, Sunday July 26, 2015.

“OMG. Have you heard about this?” she wrote in text accompanying a picture of her holding up a bottle of the pills. “I felt a lot better and most importantly, it’s been studied and there was no increased risk to the baby.”

Diclectin is a time-release pill that combines the vitamin B-6 and antihistamine doxylamine.

The FDA says any marketing of the drug should mention that it has been approved only for pregnant women who do not respond to conservative treatment, and has never been studied in women with hyperemesis gravidarum – an extreme version of nausea and vomiting in pregnancy.

Promotion must also mention side effects such as drowsiness, and that women with hypersensitivity to doxylamine ought not to take it, the letter said.

While the FDA quickly took action on the incident – partly in response to a complaint it received under its “bad ad program,” Health has been silent on the issue.

Yet a post like Kardashian’s would seem, if anything, to be a more blatant breach of Canadian rules, which bar direct-to-consumer advertising of prescription drugs entirely.

The case points to a possible “Wild West” in pharmaceutical promotion on social media, and Canadian regulators should be taking it seriously, said Joel Lexchin, an emergency doctor and health-policy professor at York University.

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Studies suggest that any drug marketing to consumers unduly influences prescribing decisions, and social media has potential to be more far-reaching and long-lasting than traditional broadcast or print ads, he said.

“The same drug in different people can have vastly different effectiveness and different safety problems, and you just can’t get that kind of information from Tweets, Facebook or anything like that,” said Lexchin.

The FDA’s response made total sense, but could be troublesome for manufacturers, said Tim Caulfield, a health law and policy professor at the University of Alberta.

The suggestion that even a social media post would have to include information about medication side effects presents a significant barrier to companies interested in the strategy, he said.

“Embedding a bunch of risk information in Kim Kardashian (posts) may take away from the personal, product placement vibe that makes social media a potentially powerful advertising tool,” he said. “It will be interesting to see how the industry responds.”

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