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FDA Takes Issue with Celebrity Drug Endorsements

FDA Takes Issue with Celebrity Drug Endorsements

Social media is a part of everyday life for many people. Whether you use Facebook, Twitter, Instagram, or another service, it’s likely you have seen a celebrity tweet or Instagram post. Most adults recognize it as harmless entertainment.

In July, however, the Food and Drug Administration (FDA) sent a stern warning to the makers of Diclegis (doxylamine succinate and pyridoxine hydrochloride) after Kim Kardashian posted an Instagram “selfie” of herself holding the drug bottle with the label prominently displayed. Kardashian has publicly stated she suffers from morning sickness with her current pregnancy. The selfie contained a long statement praising Diclegis as an effective treatment for morning sickness.

According to a New York Times report, Kardashian wrote, “it’s been studied and there was no increased risk to the baby.” She went on to encourage her followers – which number in the millions – to ask their physicians about Diclegis.

FDA Sends Warning Letter

Shortly after Kardashian’s post, the FDA issued a warning to Pennsylvania-based Diclegis maker, Duchesnay, Inc., instructing the company to stop misbranding the drug. In its letter, the FDA stated Kardashian’s social media post was “false or misleading in that it presents efficacy claims for Diclegis, but fails to communicate any risk information associated with its use and it omits material facts.”

Specifically, Kardashian completely omitted the warnings associated with Diclegis. The drug has not been studied in patients with a form of severe morning sickness known as “hyperemesis gravidarum.” It is also not advised for consumption in women who have a known sensitivity to doxylamine succinate, which is a type of antihistamine. Furthermore, women who take monoamine oxidase inhibitors (MAOIs) are not advised to take the drug.

Although the FDA generally has no authority to regulate what a third party individual says about a particular drug, it can get involved when a third party is acting on behalf of the drug maker. Kardashian’s Instagram post explicitly stated she is “partnering” with Diclegis to allegedly “raise awareness about treating morning sickness.” The post also linked to the manufacturer’s website. Neither Kardashian nor Duchesnay would release how much Kardashian was paid to promote the drug. The New York Times reports Kardashian’s post was later removed.