Pregnancy drug maker in big trouble over Kim Kardashian 'partnership'
The FDA wasn't pleased with Kim Kardashian's recent Instagram post about how she adores her morning sickness drug, and they've sent a letter to the medication's manufacturer outlining what needs to be done ASAP.
The FDA has homed in on Duchesnay, Inc., the company behind Diclegis, a morning sickness medication that Kim K apparently loves and that has a controversial past. The reality star was apparently paid to promote Diclegis, but in her now-deleted Instagram post, she failed to mention any risk factors associated with the drug itself, which is a big no-no.
The FDA's warning letter itself spells out what the trouble is, including this: "These violations are concerning from a public health perspective because they suggest that DICLEGIS is safer than has been demonstrated." The FDA required Duchesnay to respond to the letter by August 21, and the company should supply the FDA with a plan to send out corrective messages (via the same media) and/or cease producing and distributing Diclegis.
Advertising for pharmaceutical drugs is a very specific endeavor, and the FDA has rules in place so consumers know indications and possible side effects. In the early days of advertising drugs on TV, for example, there was virtually no medical information given — the result was a baffling commercial that didn't make a lot of sense. Now, prescription medication ads must include a number of elements, including the biggest potential side effects and where people can find more information on the drug.
The biggest takeaway for moms in light of this debacle: Always be wary of advertisements or recommendations that come without risk warnings or side effect information. The Kardashian situation highlights the liberties some high-profile folks take when being paid to promote something. Risks and side effect information are both quite vital when researching a medication, and as the FDA points out, a link at the bottom of Kim K's post about Diclegis that points to a website with more info isn't good enough (The main point of contention? "DICLEGIS has not been studied in women with hyperemesis gravidarum").
For many celebs, accepting compensation to promote a product or service is part of their regular work. But with something as important as medication (particularly medication that is prescribed for pregnant women), the rules need to be followed, and celebs need to look past the money and consider the health and well-being of their audience. While this may be a pipe dream, it's a sobering wake-up call for those who look up to celebs for inspiration and even guidance — and, yes, even medical advice.