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Kim Kardashian's pregnancy sickness drug posts 'violate rules'

Published 11/08/2015

Kim Kardashian and Kanye West are expecting their second child
Kim Kardashian and Kanye West are expecting their second child

Reality TV star Kim Kardashian has found herself in hot water for her social media posts promoting a prescription pill to treat morning sickness.

The US Food and Drug Administration says the posts violate federal drug-promotion rules.

Kardashian, who is marrried to rapper Kanye West, has talked about her struggles with nausea due to pregnancy in posts to Instagram and Facebook.

The star, who is five months pregnant with her second child, said in one post: "I tried changing things about my lifestyle, like my diet, but nothing helped, so I talked to my doctor. He prescribed me Diclegis, and I felt a lot better and most importantly, it's been studied and there was no increased risk to the baby."

The posts link to a company website that includes the FDA-approved labelling information.

FDA regulators say the posts violate rules for promoting drugs because they don't mention the side effects of Diclegis, which include sleepiness that can make it dangerous to drive or perform other activities that require mental alertness. The drug label warns that Diclegis should not be combined with alcohol or other medications that cause drowsiness, such as sleeping aids or certain pain relievers.

The FDA posted its warning letter online, addressed to the CEO of Canadian drugmaker Duchesnay Inc., which markets the drug. The letter notes that the privately held company received a similar warning in 2013 for omitting risk information from a letter to doctors.

FDA regulators are "concerned that Duchesnay is continuing to promote Diclegis in a violative manner," states the letter.

The agency calls on the company to remove the social media posts immediately and outline a plan for preventing future violations by August 21.

Duchesnay said in a statement it "will take quick action in responding to the FDA's letter and immediately and effectively address any issues." The company is based in Blainville, Quebec.

The FDA approved Diclegis in 2013 to treat vomiting and nausea in pregnant women who do not respond to more traditional measures. It is the only prescription drug approved in the US for morning sickness.

Kardashian's publicist did not immediately respond to a request for comment.

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