I had the privilege of caring for pregnant mothers for over 20 years (delivering over 1500 babies). During that tenure, I would tell moms, “I do NOT want you to experience ANY morning sickness during your pregnancy.”And, following the advice below, the vast majority did not!
Only about one-third of “morning sickness” occurs in the morning. About 1/3 occurs in the afternoon or evening. And, about 1/3 of women have is all day! No matter when nausea and vomiting of pregnancy occurs, using my recommendations, I found I seldom had to use any prescription remedies. So what did I recommend?
Before I tell you, let me recount for you the very sad story of a medication called “Bendectin.”
Bendectin (known as Debendox in the United Kingdom and Diclectin in Canada) was a mixture of pyridoxine (Vitamin B6) and doxylamine (an antihistamine) that was prescribed to treat nausea and vomiting associated with morning sickness. It was nearly 100% effective. So why is it no longer available?
The manufacturer, Merrell Dow Pharmaceuticals, spent more than $100 million defending the subsequent personal injury lawsuits, winning courtroom victories in the virtually all of their cases. Nevertheless, to reduce litigation expenses, the company voluntarily removed the drug from the U.S. market in 1983.
Not only did an FDA panel conclude there was no association between Bendectin and birth defects, over 30 epidemiologic studies have concluded that Bendectin was safe for use in pregnancy. Also, the World Health Organization and the March of Dimes have exonerated the drug. The Centers for Disease Control and Prevention hasn’t found any reduction in birth defects nationally since Bendectin was pulled from the market.
The most famous case involving the drug is Daubert v. Merrell Dow Pharmaceuticals (1993). These suits were led by flamboyant plaintiff attorney Melvin Belli. The star witness for the case against Bendectin, William McBride, was later found to have falsified research on teratogenic effects of the drug, and was disbarred in Australia.
The drug continues to be used around the world (not only in Canada and the UK, but also across Europe) and no subsequent epidemiological studies have found any teratogenic effect.
Bendectin consisted of 10 mg of pyridoxine (vitamin B6) and 10 mg of the antihistamine, doxylamine, combined in a single tablet. It could be taken up to four times per day.
To create a “do-it-yourself” Bendectin, you can either purchase pyridoxine in 10 mg tablets, or purchase scored 25 mg tablets and pop them in half.
Since a 10mg dose of doxylamine is not (to my knowledge) available in the United States, the closest American patients can get to Bendectin is to take one-half of a 25-mg tablet of doxylamine in the form of Unisom Sleep Tabs. But, be careful, as one form of Unisom (Unisom Sleep Gels) contains NOT doxylamine, but another antihistamine, diphenhydramine (Benadryl).
Since doxylamine is sleep inducing, I had my patients do this:
- Start with 10-12.5 mg of pyridoxine (vitamin B6) three times a day for 2 days. If not fully effective,
- Increase to 12.5 mg of pyridoxine four times a day for 2 days. If not fully effective,
- Increase to 25 mg of pyridoxine three times a day for 2 days. If not fully effective,
- Continue 25 mg pyridoxine 3 times a day, and add 12.5 mg of doxylamine before bedtime each day for 2 days. If not fully effective,
- Continue 25 mg pyridoxine 3 times a day, and take 12.5 mg of doxylamine twice a day. If not fully effective,
- Continue 25 mg pyridoxine 3 times a day, and take 12.5 mg of doxylamine three times a day. If not fully effective,
- Continue 25 mg pyridoxine 3 times a day, and 12.5 mg of doxylamine 3 times a day, while adding Emetrol, one to two tablespoons (15-30 cc) taken once or twice a day as needed. (Emetrol is an over-the-counter mixture of sugar syrups and phosphoric acid [phosphorylated carbohydrate solution]) that acts by soothing the actual wall of the gastrointestinal tract). If not fully effective,
- Consult with your doctor.
Once you find your effective dose, continue it for a week or two and then “walk back down the dosing ladder” to find the lowest effective dose of medication to keep your nausea away. After a few weeks, you may be able to discontinue the treatment completely.
I do not recommend more than 25 mg of pyridoxine three times a day. Why? A total daily dose of pyridoxine of more than 75 mg a day in pregnancy may cause problems with the nerves (neurotoxicity).
But, what if my recipe does not work?
I used to recommend oral ginger capsules. But, now new reports are questioning the use of ginger during pregnancy. The newest report, from the Finnish government, is warning pregnant women not to consume ginger supplements, drinks, or teas.
Why? Ginger contains chemicals that are cytotoxic in vitro. The concern is that these chemicals MIGHT be harmful to the unborn baby if consumed in large quantities.
So far, no obvious problems have been seen in pregnant women taking ginger supplements in doses of about one gram daily. But, I think it’s better to be safe than sorry.
So what is your doctor left with if the OTC meds do not work for you? A number of prescription medicines. Fortunately, I have rarely had to use any of these:
- Metoclopramide (Reglan), even though in the U.S. it only has FDA approval for use as a treatment for patients suffering heartburn and esophagitis due to acid reflux. Nevertheless, it’s often recommended as a treatment for morning sickness if other therapies have failed and appears to be a safe and effective treatment for morning sickness. HAS MOVED TO #1 ON THE LIST IN 2014. READ UPDATE BELOW.
- Prochlorperazine (Compazine).
- Promethazine (Phenergan).
- Tigan (Trimethobenzamide) is an actual antiemetic (anti-nausea medication), probably related to anesthetics.
- Zofran (Ondansetron) is a very powerful antiemetic. Its exact mechanism of action unknown. But it has MOVED FROM #2 to #5 in 2014. READ UPDATE BELOW.
If you give my recipe a try, leave a note for me and our other readers about what dose worked for you.
OCTOBER 2013 UPDATE: I happy to let my readers know that (1) this is by far the most popular (and, I hope, helpful) blog I’ve written, and (2) the U.S. Food and Drug Administration just approved Diclegis® (doxylamine succinate 10mg, pyridoxine hydrochloride 10mg) delayed-release tablets, the first prescription treatment for nausea and vomiting of pregnancy (NVP) when conservative management fails in more than 30 years. However, it’s not cheap. In our area (Colorado Springs), the least expensive price for 30 tablets is about $155.00. For some women it can cost over $500/month. But, for those with insurance, it may well be worth considering.
JANUARY 2014 UPDATE: This, just out from the experts at the Prescriber’s Letter (2014(Jan); 21(1): 5:
Questions will come up about using ondansetron for morning sickness. It was thought to be relatively safe … but now there are concerns. Ondansetron use in the first trimester is linked to a two-fold increase in the risk of congenital heart defects and cleft palate. Plus ondansetron prolongs the QT interval … and electrolyte disturbances due to vomiting can increase the risk of torsades.
When drug therapy is needed for morning sickness, recommend OTC pyridoxine AND doxylamine 12.5 to 25 mg up to TID … or use the Rx combo product, Diclegis. But point out that Diclegis can cost over $500/month. If pyridoxine and doxylamine are not enough, try metoclopramide or a phenothiazine (prochlorperazine, etc). Save ondansetron for when other options aren’t enough. Monitor ECG and electrolytes for women with significant vomiting.