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FDA slams Kardashian West's Instagram drug promotion

Morning-sickness drug firm Duchesnay criticised over social media marketing

Kardashian  

The FDA has found an unlikely target in its policing of drug advertising - US reality TV star Kim Kardashian West.

Kardashian West's use of the picture sharing social media site Instagram to promote morning-sickness pill Diclegis (doxylamine succinate and pyridoxine hydrochloride) to her 42 million followers prompted the FDA's Office of Prescription Drug Promotion to write to the drug's manufacturer Duchesnay.

The warning letter, sent to Duchesnay's executive vice president Eric Gervais on 7 August, described Kardashian's actions as “false and misleading” and stressed her failure to mention the potential risks associated with Diclegis.

The letter continued: “The social media post is 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.”

Kardashian West's post did however acknowledge that she was working with Duchesnay, and included a link to the safety information website for Diclegis.

The ODPD judged, however, that the link failed to “mitigate the misleading omission of risk information”. Kardashian West also failed to mention that Diclegis has not yet been studied in women with the severe pregnancy sickness condition hyperemesis gravidarum.

The ODPD stressed that the violations highlighted did not necessarily constitute an exhaustive list, and that failure to address them could lead to regulatory action without further notice.

The offending post was removed from Kardashian West's Instagram feed on 11 August.

Since then, Duchesnay has acknowledged that its communications, including in social media, “need to be in accordance with all applicable rules and regulations”.

The Canadian company said in a statement: “We are taking quick action in responding to the Food & Drug Administration's warning letter and immediately and effectively address any issues.

“We appreciate and fully support the FDA's objective of ensuring that promotions remain consistent with approved labelling."

Doxylamine succinate and pyridoxine hydrochloride was originally marketed as Bendectin in the US from 1956, but was pulled from the market in 1983 after its makers Merrell Dow faced several legal battles from people claiming the drug caused birth defects.

But in 2013 the FDA has said that Duchesnay could once again market a new version of the drug under a new name - Diclegis.

Jump in morning sickness conversations

But despite the letter, Kardashian West's role as a spokesperson for the morning sickness pill - coming as she is pregnant with her second child - has seen online conversations about the brand jump by more than 500%, according to patient data firm Treato, which monitors online exchanges on medicines and health.

Treato's analysis also found that 29% of all online conversations in July about Diclegis included Kim Kardashian, and that she was the second most discussed topic with Diclegis, after morning sickness.

Data also shows that on the day Kim Kardashian West became a spokesperson for Diclegis, online conversations happening about the medication increased more than 6.3 times what it had previously been the day before.

Treato said that in the month of July, Diclegis was discussed online more than three times more frequently than Phenergan (promethazine), the second most popularly discussed medication to treat morning sickness.

Article by
Tara Craig

20th August 2015

From: Marketing

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