Kim Kardashian's social media posts for morning-sickness pill 'contravenes Canadian ban,' health lawyer says
FDA says Kardashian's paid endorsements suggest drug is safer than has been demonstrated
Reality TV star Kim Kardashian's social media posts about a Canadian pharmaceutical company's morning sickness treatment has raised questions about drug promotions online.
Kardashian posted on Instagram, Facebook and Twitter about how a prescription drug to treat morning sickness helped her overcome nausea during pregnancy.
Kardashian posted the paid endorsement, including a photo showing her holding a bottle of Diclegis.
"I felt a lot better and most importantly, it's been studied and there was no increased risk to the baby," the caption, now deleted, read.
The posts linked to a company website that includes the U.S. Food and Drug Administration-approved labelling information.
On Tuesday, the FDA said Kardashian's posts on social media violate drug promotion rules in the U.S. because they suggest "that it is safer than has been demonstrated."
Direct-to-consumer ads for prescription drugs are generally prohibited under Canada's drugs regulations. A loophole in its interpretation allows reminder ads that name a product but not its use. For example, TV ads for the erectile dysfunction drug Viagra don't name its purpose.
- 7 morning sickness prevention and treatment suggestions
- Kim Kardashian's social media posts for morning-sickness violate drug promotion rules: FDA
- Prescription drug ad law notable for 'lack of teeth'
"This social media strategy clearly contravenes the Canadian ban," health law Prof. Timothy Caufield of the University of Alberta said from Helsinki.
CBC News asked Health Canada what actions it was taking in regard to Kardashian's promotion of the drug. "Health Canada has contacted the manufacturer of Diclectin, also known as Diclegis in the United States, and directed the company to refrain from engaging in subsequent advertising practices of a similar nature," a spokesman responded in an email.
Dr. Nav Persaud, a family physician in Toronto, said he has stopped prescribing Diclectin, because he is not convinced about its safety and effectiveness.
"I'm very concerned about women being misled. I think this is a huge step backwards away from studying how effective medications are in trials to basing decisions on the experience of one person, in this case a very influential person," Persaud said.
Diclectin's Quebec-based manufacturer, Duchesnay Inc., markets the drug.
"Duchesnay USA takes our regulatory responsibilities very seriously, and acknowledges that our communications, including in social media, need to be in accordance with all applicable rules and regulations," a spokeswoman said in an email.
"We are taking quick action in responding to the [U.S.] Food and 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.
Duchesnay USA stands by its product and notes the FDA's warning letter does not question the safety or efficacy of the product. The company said the issues raised relate to omission of risk information, limitations of use, and safety information."
Kardashian's representative, Ina Treciokas, said the social media posts were written together with the drug company.
Persaud is concerned a new era of celebrity drug ads has just begun on social media and the proper warnings about potential side-effects won't be posted.
With files from CBC's Vik Adhopia, Thomas Daigle and The Associated Press