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Everything Old is New Again when it comes to Morning Sickness

Thursday, December 19th, 2013

Back in the 60s, and 70s, when I was a medical student, resident and perinatal Fellow, the drug of choice of morning sickness was Bendectin.  Bendectin, Bendectin, Bendectin.  It was prescribed like jellybeans to pregnant women in their first trimester to treat nausea and vomiting of pregnancy (morning sickness). It worked!!  I don’t think I would have gotten through my certification Boards without Bendectin when I was eight weeks pregnant with my daughter.

Then, all of a sudden, its was unceremoniously removed from the market and was unobtainable in 1983.  Why? Because the original manufacturer, Merrell Dow, could not continue to defend the lawsuits brought against the drug for supposedly causing birth defects.   After numerous horrific episodes of birth defects due to Thalidomide (which was not FDA approved in this country), women were quicker to blame medications taken during pregnancy for complications and birth defects.  Unfortunately, attorneys set their sights on Bendectin, which became the “whipping boy” for medications taken during early pregnancy and soon the mounting lawsuits (which were unfounded) resulted in its removal from the market.  In other words, this very effective medication was removed totally based on fear.

However, those of us who knew that the ingredients were just an antihistamine (doxylamine) and Vitamin B6 (pyridoxine), continued to direct our patients to the over-the-counter combination of Unisom and Vitamin B6.  In 2004, the American College of Obstetricians and Gynecologists sanctioned this jerry-rigged, improvised approach to “homemade” Bendectin as a first-line treatment for nausea and vomiting of pregnancy (morning sickness).

Well, thirty years later, a “new” drug, under a new manufacturer, called Diclegis (the brand name for doxylamine succinate and pyridoxine hydrochloride) was approved by the FDA earlier this year for use in pregnant women for the treatment of nausea and vomiting.  The drug is exactly the same as Bendectin.  However, this time, it has been categorized as Class A by the FDA, which means that there is no evidence that the drug causes birth defects in the human fetus.  With this FDA category of Class A, hopefully, it will reduce the threat of lawsuits.

As you are probably aware if you are or have been pregnant, so-called “morning” sickness can actually strike at any time of day, even lasting all day long in some cases. There are simple self-care strategies to try that are effective in many cases: avoiding fatty foods, eating smaller, more frequent meals, and avoiding smells that seem to trigger nausea. However, more often than not, these measures are not enough. Diclegis offers a welcome solution for many women.

Studies have shown Diclegis to be effective and safe. 261 women who had been pregnant for anywhere from seven to 14 weeks, were all 18 years old or older, and were all experiencing nausea or vomiting, were evaluated. In the study, there was more of a decrease in nausea and vomiting seen in women who took Diclegis than in women who took a placebo. The drug was also found to be completely safe for the fetus.

Women whose doctors prescribe Diclegis can expect to take two pills at night to start with. If this does not improve symptoms, the dose can be increased to a total of four pills per day (one in the morning, one in the afternoon, and two at night). Drowsiness is among the possible side effects (because of the antihistamine), so women who take the drug should not drive. If you have questions about Diclegis or need further information on morning sickness, see my book, Inside Information for Women, and talk to your doctor. He or she can help you decide if Diclegis is the right choice for you.

Pregnant women who suffer from morning sickness may be worried that their babies aren’t getting enough nutrition, but in most cases, there is no cause for concern. The caloric needs of a fetus are tiny, especially in the first trimester, when the majority of morning sickness occurs. Occasionally a woman develops hyperemesis gravidarum, which is a very severe form of morning sickness in which she may not even be able to keep water down and may need to be hospitalized. Diclegis has not been tested on women with this form of severe nausea and vomiting.

– Yvonne S. Thornton, M. D., M. P. H.