The FDA is mad at Kim Kardashian.
Why? She broke their drug advertising rules.
She wanted to let her 40 million Instagram followers know how excited she was about her new drug - Diclegis. She said her morning sickness was pretty bad but with the drug she feels "a lot better". Her great excitement led her to become a paid celebrity spokesperson for the drug company.
Her Instagram post - a kind of stealth direct-to-consumer ad - crossed the line. She made a claim about the drug's benefit that broke the rules because she didn't mention the drug's side effects. The FDA wrote an angry letter to the company and Kardashian took down the post.
How can the millions of women with morning sickness decide whether or not to try the drug? They could take Kim's paid word for it - or should they get the facts?
To get the facts, we at Informulary went to the best source - the FDA's reviews. These reviews - unfiltered by drug companies - explain how FDA judged the drug's benefits and harms seen in the clinical trials.
So how well does the drug work? Not much. The FDA review team leader concluded the benefit was "small".
The 1 trial randomly assigned 261 women with morning sickness to either Diclegis (which must be taken every day- not “as needed”) or placebo. Morning sickness symptoms of nausea, dry heaves and vomiting were measured on the PUQE scale (yes pronounced puke). Women who took Diclegis got better by 4.6 points. But women who took placebo got better by 3.9 points. So Diclegis made women only 0.7 points better than placebo on the 13-point scale.
What about the side effects? Kardashian is right that FDA feels the drug is not dangerous to the baby. But it does have a few bothersome side effects - most importantly it can make women feel drowsy (15% of women taking Diclegis felt drowsy versus 12% taking placebo). That may not sound like a lot but FDA warns women not to take the drug if they need to be doing activities that require "mental alertness" like driving. And FDA says mixing Diclegis with alcohol, antihistamines or other drugs that can make you drowsy is dangerous. The combination can make you so drowsy that you might fall or get into an accident.
The bottom line: Most women who take Diclegis will not "feel a lot better" - they might feel a little better. The FDA is not worried about harm to the baby. But they are worried about the drug making women feel sleepy - especially if they mix it with alcohol or other drugs that make you sleepy. With the facts in hand, now you can decide whether you want to keep up with a Kardashian.
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