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Morning Sickness Pill Gets FDA  Approval

 

In a few weeks, my sister is having another baby, and she can’t wait for it to be over. For some reason during this pregnancy she experienced morning sickness well into her 6th month.  During my pregnancy, I can’t remember ever having to deal with it, but I feel the pain for all of my family member and girlfriends who have.  Years ago there was a treatment for morning sickness, called Bendectin, but it  was taken off the market after a false-alarm scare that claimed it caused birth defects. On Monday, the FDA approved a new version of the drug, and gave it a new name, Diclegis.

My grandmother would scoff at such drugs, and then hand a pregnant woman some saltine crackers.

The New York Daily News reports:

Monday’s FDA decision means a new version of the pill once called Bendectin is set to return to U.S. pharmacies under a different name — Diclegis — as a safe and effective treatment for this pregnancy rite of passage.

In the intervening decades, the treatment is widely believed to have undergone more scrutiny for safety than any other drug used during pregnancy.

“There’s been a lot of buzz about this. Nothing better has come along” to treat morning sickness in those 30 years, said Dr. Edward McCabe, medical director for the March of Dimes, who welcomed the step.

“We know safety-wise, there’s zero question,” said Dr. Gary Hankins of the University of Texas Medical Branch in Galveston, who headed one of the company-financed studies of Diclegis that led to its approval.

U.S. sales of Diclegis are expected to begin in early June, according to Canada-based manufacturer Duchesnay Inc. The company has long sold a generic version of the pill in Canada under yet another name, Diclectin.

The ingredients in Diclegis are pretty much common drugs you can find over the counter, vitamin B6, plus an antihistamine doxylamine, found in the sleep aid Unisom. Apparently doctors have been giving women advice on how to properly mix the two drugs to relieve themselves of nausea.

Once again, my grandmother would say, “Get you some saltines”.

Of course with any drug, there were case studies done and noted side effects, which the FDA covered in their short press release:

Diclegis was studied in 261 women experiencing nausea and vomiting due to pregnancy. Study participants in the clinical trial were at least 18 years old and had been pregnant for at least 7 weeks and up to 14 weeks. Women were randomly assigned to receive two weeks of treatment with Diclegis or a placebo. The study results showed that women taking Diclegis experienced greater improvement in nausea and vomiting than those taking placebo. Additionally, observational (epidemiological) studies have shown that the combination of active ingredients in Diclegis does not pose an increased risk of harm to the fetus.

 

Diclegis is taken daily. Tablets must be taken whole on an empty stomach. The recommended starting dose is two tablets taken at bedtime. If symptoms are not adequately controlled, the dose can be increased to a maximum recommended dose of four tablets daily (one in the morning, one mid-afternoon and two at bedtime).

 

Nausea and vomiting due to pregnancy usually improve after the first trimester. Health care professionals should reassess their patients for continued need for Diclegis as pregnancy progresses.

 

Drowsiness or sleepiness, which can be severe, is the most common side effect reported by women taking Diclegis. Women should avoid using Diclegis when engaging in activities requiring mental alertness, such as driving or operating heavy machinery, until cleared to do so by their health care provider.

Whatever the case may be, there’s a pill for everything nowadays. Lets just wait to see how long some new birth defects and lawsuits pop up.

 

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