A few weeks ago I posted an article from Drug Watch telling women of the dangers of Transvaginal Mesh, used to treat urinary incontinence. As we were planning that post, I asked them their opinion on the drug Diclegis, a medication that had been recently re-released/approved by the FDA to treat morning sickness. According to what I was reading, the drug had been wrongly accused of increasing the risk of birth defects. I was a little suspicious as I often am LOL, and I didn’t have a lot of time to research the medication. Fortunately, the folk over at DrugWatch.com love sharing truth about medications. Below is their input on Diclegis. Are you experiencing nausea and vomiting in pregnancy. Learn more… and always remember… No. Matter. What… Ask before you say yes.
Diclegis Approved by FDA for Morning Sickness
A drug that was pulled from shelves 30 years ago in response to lawsuits alleging that it caused birth defects is back on the market.
Diclegis, a combination of vitamin B6 and the over-the-counter antihistamine doxylamine, is prescribed for pregnant women whose morning sickness does not respond to lifestyle changes such as small, bland meals, acupressure wrist bands and meditation.
Doctors have prescribed the two ingredients in the drug as a combination treatment for morning sickness for years, but Diclegis will be the first single-capsule, time-release version of the medicine in three decades.
A Long Journey Back
Diclegis was first sold under the name Bendectin in 1956, and an estimated 33 million women were prescribed the drug. Bendectin was removed from the market in 1983 when its manufacturer decided it could not afford to continue to defend the drug from lawsuits.
Much of the controversy and legal trouble for the drug stemmed from the hysteria surrounding thalidomide, a drug marketed as a safe sleeping pill for pregnant women that resulted in the horrible disfiguration of newborns. After the terrible results of thalidomide, women were much quicker to blame birth defects on medication.
Since then, studies have concluded that Bendectin had no effect on the baseline risk for birth defects, which is 1 in 33 babies. According to Dr. Keith Eddelman, the director of obstetrics at the Mount Sinai Medical Center in New York City, “This new FDA medication is a great option for pregnant women suffering from morning sickness,” and the data are very convincing that the drug poses no risk and should never have been taken off the market.
The FDA agrees, saying in a press release that observational studies have shown that the combination of active ingredients in Diclegis does not pose an increased risk of harm to the fetus. Side effects of the drug do include severe drowsiness, however, so the FDA recommends that patients taking Diclegis avoid using heavy machinery such as cars until they know how it affects them.
Always Be Cautious
As always, use of prescription drugs in pregnant women should be a last resort. In most cases, morning sickness is not serious enough for a prescription medication. If someone is vomiting hourly, however, the benefits of Diclegis greatly outweigh its risks.
It’s important for women to do their research before taking any medication during pregnancy. While Diclegis does not have serious documented side effects, certain antidepressants like Zoloft, Paxil and Prozac have been linked to birth defects, along with risky behaviors such as alcohol consumption and smoking. Women need to make sure their doctor knows about any and all medications they are on if they are pregnant or planning to become pregnant.
Linda Grayling is a writer for Drugwatch.com, a consumer advocacy website. She stays up to speed on the latest medical news, including recalls and clinical trials.