The Oldest, the Newest, and the Only FDA Approved Drug for Severe Nausea and Vomiting during Pregnancy
In 1956, the FDA approved a medication called Bendectin for nausea and vomiting in pregnancy. The same drug was known as Diclectin in Canada, Debendox in the UK and Australia and Lenotan in many other countries. It consisted of a combination of the vitamin pyridoxine and doxylamine succinate, an antihistamine. In short, a B vitamin and an over-the-counter sleeping medication. That’s it.
Diclegis® is a prescription medicine used to treat nausea and vomiting of pregnancy in women who have not improved with change in diet or other non-medicine treatments.
LIMITATIONS OF USE
It is not known if Diclegis® is safe and effective in women with severe nausea and vomiting of pregnancy, a condition called hyperemesis gravidarum. Women with this condition may need to be hospitalized.
At the time, it also contained a third ingredient called dicyclomine hydrochloride. (For those curious, the 2nd part of the drug name is the salt that the active ingredient is mixed so it can be formed into a oral tablet or capsule.) Dicyclomine was removed after the FDA passed the Food, Drug and cosmetic Act in 1975. This act required the testing of medications to be found efficacious, and dicyclomine did not pass this test so it was removed soon after.
While American women were taking Bendectin, Europeans at the same time were given Thalidomide, which resulted in a rash of babies being born with severe birth defects. (Thanks to one amazing woman at the FDA, Thalidomide was never approved in the US https://en.wikipedia.org/wiki/Frances_Oldham_Kelsey). A side effect of this resulted in women whose babies were born with birth defects in the US blaming it on Bendectin. The first lawsuit was in 1977, and women believed the National Enquirer magazine when it published an article saying it may cause birth defects in 1979. Lawsuits continued into 1980s, despite large studies in the US, Canada and abroad, showing it does not cause an increased risk of birth defects. In 1980, the FDA said it was safe. Regardless, the Merrell Dow Corporation took it off the market in 1983 due to the large cost of liability insurance along with exorbitant legal fees.
Since that time, women suffering from nausea and vomiting in pregnancy bought the two ingredients separately over the counter in drug stores, pyridoxine from the vitamin section and doxylamine from the allergy or sleep section, and the studies continued. In fact, it’s now considered one of the most studied medication regimens, and in 1999, the FDA changed the rating of the combination to a category A. Very few medications ever get this rating, which means it’s been clinically proven as not to increase a risk of birth defects; the safest rating possible https://www.bendectin.com/en/
In 2013, the ingredients in Bendectin were were FDA approved under the name Diclegis, manufactured by Duchesney, which from what I can tell is the exact company that had been making it in Canada for decades. The thing about pharmaceutical companies that we see over and over is unnecessary astronomical pricing. Despite being basically the same drug, Diclegis retails for $570 for a one month supply, and it’s often not covered by insurance. When I see this prescribed to pregnant women, yet their insurance doesn’t cover it, I happily walk them to the vitamin and sleep section, and show them the OTC equivalent for a total of around $10. While the dose is not exact, it is close enough. https://abcnews.go.com/Health/fda-approves-morning-sickness-pill-pulled-market/story?id=18914496
In 2016, the FDA approved a long acting version of the same medication under the name Bonjesta, manufactured by Duchesney, the same company that manufactures Diclegis. The only difference is that it has a multilayered coating. This makes it so that it releases a bit of the medication over time instead of making you swallow 3-4 tablets in a day.
“Bonjesta® has not been studied in women with hyperemesis gravidarum.” This disclaimer is on the packaging of both Diclegis and Bonjesta. Of course it wasn’t studied in HG patients, because when all the studies were done back in those earlier decades, nausea and vomiting in pregnancy did not differentiate between morning sickness and HG. The good news is, at least the pharmaceutical companies today are acknowledging HG which is a big change from decades past.
Today, Diclegis and Bonjesta are the only medications that are FDA approved for morning sickness, and Vitamin B6 (pyridoxine) with doxylamine (Unisom) is the first line in the treatment guidelines. The only difference is the dose. Do you think it helps with HG? Tell me your experiences with these two ingredients at firstname.lastname@example.org, and I’ll share the feedback.