Kim Kardashian's first trimester nausea: The truth behind Diclegis

It was only a matter of time before Kim Kardashian posted a picture on her Instagram account with a bottle of Diclegis, basically announcing her brand partnership with Duchesnay, the manufacturer of the prescription medication for nausea and vomiting in pregnancy. Duchesnay had been tweeting for ages that they were so relieved Kim had found help with Diclegis — so much so that I was wondering if Ms. Kardashian was possibly having the longest first trimester known to womankind.

While the FDA was all over the Instagram post, I suppose they didn’t jump on the promoted tweets (which sure looked like advertising to me), because the link in the tweet took you to a page that actually listed side effects and contraindications. Although I think promoted tweets with a celebrity name is a pretty sly way around the rules. How many people really click through and read the fine print versus bring up a screen shot of the promoted tweet and ask their doctor for the medication that helped Kim?

But the FDA aside, I find Ms. Kardashian’s claim that she found the drug on her own somewhat surprising. She has an OB, and honestly I have a hard time imagining her doctor not bringing it up if she mentioned an issue with nausea and or vomiting. The cynic in me wonders if her doctor only mentioned the over-the-counter (OTC) option.

Yes, while you can buy Diclegis as a prescription it is just a combination of two readily over-the-counter (OTC) medications — vitamin B6 and doxylamine (an antihistamine) with slightly different dosing. When taken together doxylamine and vitamin B6 are mildly to moderately effective for nausea and vomiting in pregnancy. The difference between the prescription and the OTC is a minor variation in dose, and the prescription is delayed-release so it is only taken once a day. However, there has been no head to head comparison between the OTC and prescription, so we have no idea if the delayed-release offers any advantage beyond the convenience of once daily dosing.

The big difference between the OTC option and Diclegis is price. You can buy 100 doxylamine 25 mg tablets for $12.79 and 100 vitamin B6 tablets 25 mg for $7.29 (see below), and you can bet the manufacturers are still making a profit. Diclegis, if you have a coupon, is $345 for 60 tablets. The dose is two tablets a day, but some women need four tablets so the cost for could be $690 a month (with a discount coupon!). Some may get it covered by insurance, but even then co-payments are likely to be $20 or more. You will pay at most $25.20 a month for OTC (less if you don’t need four pills a day and/or take advantage of the buy one get the other 50% off at Walgreens). The other advantage of the OTC route is you can start with vitamin B6 and if that doesn’t work then add in the doxylamine. After all, we recommend a step-wise approach to nausea and vomiting.

Let’s compare OTC doxylamine/vitamin B6 with Diclegis. The OTC dosing is not identical but close enough and before 2013 (when Diclegis wasn’t available) we managed just fine using these slightly different doses. Check out this table:

While doxylamine and vitamin B6 may help many pregnant women, for most Diclegis is an unnecessary medication. I’m not saying unnecessary to downplay nausea and vomiting — I suffered terribly in my pregnancy with nausea, so I am very empathetic. I’m saying unnecessary because at that price and without studies showing medical benefit of a delayed-release formulation the prescription should only be considered if the OTC version isn’t working, Perhaps for some women the delayed-release might be better and since there are more studies on doxylamine/vitamin B6 than other options it makes sense to step up to this after trying the OTC option and before other prescriptions are tried.

If your insurer pays for you to take Diclegis and you haven’t tried and failed the OTC combination that’s several hundred dollars that could have been spent elsewhere. Your insurer will make up the difference somewhere, typically by higher co-payments for delivery.

Every single OB/GYN and pharmacist I know believes Diclegis came out with the delayed-release formulation to break into the amazingly pharma-friendly U.S. health care market because they knew they could do minimal work and charge insurers a bazillion dollars. In fact, when I retire and no longer have to worry about conflicts of interest I will invest in big pharma because they literally get away with crippling the American health care system. OK, probably not because I want my kids to be able to afford health care, and I want to sleep at night, but you get the idea.

Diclegis is nothing special — it’s no brand new wonder drug. If it had been studied head to head with the OTC products and found to be clearly superior, that would be different. It’s hard to make sense of a regulatory agency that is primed for this kind of manipulation.

Meanwhile, I’m just waiting to see what birth control pill or IUD Ms. Kardashian is going to talk about once her seemingly eternal pregnancy comes to fruition I’m sure she has learned a marketing lesson and instead of an Instagram photo shoot complete with full makeup and fake eyelashes (because that is exactly how Diclegis makes you feel, right?! ) it will be casually dropped in conversation on her show or in an interview. Hey, maybe you will be able to buy a digital version in her game!

I wonder how many Birkin Bags the insurance companies (and hence your dollars) are buying for Ms. Kardashian through the middlemen at Duchesnay. And remember, no matter how much they are paying Ms. Kardashian the folks at Duchesnay are making exponentially more. Remember, $5.75 for a pill that makes a profit at $0.21.