August 13, 2015

Food and Drug Administration: reality T.V. star violated federal drug marketing guidelines

reality TV star Kim Kardashian warned by FDA over marketing morning sickness drug  Diclegis® on Instagram

FDA warns Kim Kardashian over marketing morning sickness drug on Instagram.

Kim Kardashian’s endorsement of the morning sickness drug Diclegis on social media has drug maker Duchesnay USA under pressure from the Food and Drug Administration. In an Instagram post gathering almost half a million “likes,” Kim Kardashian claimed the morning sickness medication made her feel “a lot better and most importantly, it’s been studied and there was no increased risk to the baby.”

According to the FDA, Kardashian’s messages failed to properly inform consumers about the risks associated with the morning sickness drug. Duchesnay admits Kardashian is a paid spokesperson for the company. In her post, Kardashian discloses that she’s “partnering” with Duchesnay USA to “raise awareness” about treating morning sickness.

The FDA’s letter to Duchesnay asks the company to publish a revised message about Diclegis over the same media to the same audience, meaning Kardashian may have to take to social media to correct her misleading statements. Kardashian has more than 40 million followers on Instagram, which is owned by Facebook.

Diclegis is the only medication approved by the FDA to treat morning sickness symptoms. Known side effects include sleepiness and drowsiness but Diclegis has not been studied on women with hyperemesis gravidarum, a condition of extreme and persistent nausea during pregnancy.

Duchesnay said in a statement that it contacted the reality TV star Kardashian after the company found out she was experiencing morning sickness and using Diclegis to treat the symptoms. Duchesnay has not revealed how much Kardashin is being compensated or if the drug maker had any part in crafting the social media posts under scrutiny by federal regulators.

The FDA is struggling to sift through the massive volume of social media endorsements by celebrities which may violate federal regulations. The Federal Trade Commission also has its own guidelines for celebrity drug endorsements, requiring those endorsing the drug to be actual users and to disclose any financial arrangements.

The FDA was alerted to Kardashian’s problematic Instagram post through its “Bad Ad” program – a program that enlists the help of healthcare providers to report misleading or false prescription drug ads. Under federal regulations, prescription drug ads must be consistent with FDA-approved prescribing information, only contain information supported by evidence, balance risks and benefits, and be accurate. Common legal violations include misleading comparisons to other drugs, overstating a drug’s efficacy, promoting “off-label” drug uses, and downplaying a drug’s side effects and risks.