FDA makes it clear: drug side effects must be disclosed in social media posts

by Mandy Hicks

Recently, the U.S. Food and Drug Administration sent a not-so-friendly letter to to a drug manufacturer concerning a certain reality star’s social media post about a medication she is allegedly taking to help her deal with morning sickness during her pregnancy.

While it may seem like just another nugget of celebrity gossip, the FDA’s letter is important because it brings to light the influence that so-called “celebrity endorsers” can have on their massive fan base.  The FDA calls the celebrity endorsers and the drugs’ manufacturers to task for not mentioning drug side effects as required by federal law.

Why the FDA Got Involved

At first glance, it may seem odd that a governmental entity sent a letter to someone about a social media post. The opinions that people express on social media would not seem to be subject to government regulation, right? Sometimes, perhaps. But definitely not when the person expressing the opinion is “partnering” with a drug company and touting the benefits of a drug to millions of followers but skips describing the drug’s side effects, as clearly required by federal regulations.

Therefore, when Kim Kardashian posted on Instagram about the benefits of her morning sickness medicine, Diclegis (even going so far as to say that studies showed “no increased risk to the baby”), the FDA was quick to step in and warn the manufacturer (Duchesnay, Inc.) that its celebrity endorser had stepped over the line by not including drug side effects in her post.

The Drug’s Side Effects

The FDA informed the manufacturer that Kardashian’s post was “false or misleading” under the Federal Food, Drug, and Cosmetic Act in that it presented efficacy claims without communicating risk information. The FDA reminded the manufacturer that Diclegis is contraindicated in certain women, can affect mental alertness, and has been reported to cause somnolence.

The FDA letter also mentioned a prior communication with the manufacturer concerning the same medication and stated that the fact that Kardashian included links to the manufacturer’s website at the end of her post was not enough. It did not mitigate her omission of risk information and drug side effects that should have been included in the body of the post.

Although the post was reportedly taken down after the FDA’s letter, no doubt millions of people saw the post and may be under the false impression that the endorsed drug comes with no side effects.  It can, like any drug, have numerous side effects and can be particularly dangerous when interacting with certain other medicines.

If You Have Concerns About a Possible Pharmaceutical Injury

While the FDA was swift in its response to this situation, letters and warnings can only go so far in safeguarding the public against dangerous medications. If you or a family member has been hurt because of a drug, you owe it to yourself to seek legal counsel about your case as soon as possible. To schedule a free initial consultation with one of our Bowling Green pharmaceutical injury lawyers, call English, Lucas, Priest and Owsley at 270-781-6500. We represent people injured by dangerous drugs, car accidents, tractor trailer accidents and much more throughout south central Kentucky and beyond.

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