FDA Approves Morning Sickness Drug

Wednesday, April 10th, 2013

The Food and Drug Administration has approved the return of a drug that was widely used to treat morning sickness until it came off the market 30 years ago.  Bendectin, now called Diclegis, will return to the market in early July after extensive study has shown it is safe and effective.  Time.com has more:

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.

For all the names, the main ingredients are the same: Vitamin B6 plus the over-the-counter antihistamine doxylamine, found in the sleep aid Unisom. U.S. obstetricians have long told nauseated pregnant women how to mix up the right dose themselves.

In fact, in 2004 the American College of Obstetricians and Gynecologists issued guidelines calling the combination a first-line therapy.

The difference that prescription-only Diclegis would offer: Combining both ingredients with a delayed-release coating designed to help women take a daily dose before their nausea sets in.

This news follows a Danish study last month that showed that Zofran, another morning sickness medication, is also safe.

Image: Woman suffering from nausea, via Shutterstock

Premature Birth Rate Drops for 5th Consecutive Year

Wednesday, November 14th, 2012

The number of premature births in the United States has dropped to 11.7 percent of all births, the lowest number in a decade, and the 5th consecutive year the number has fallen. This news from the March of Dimes in its annual Premature Birth Rate Report Card. Though the U.S. as a whole earned a “C” grade from the report card, four states–Vermont, Oregon, New Hampshire, and Maine–earned “A” grades for their excellent prenatal health education programs and other measures, including smoking cessation programs, that help reduce preterm birth rates.

The March of Dimes has set a goal of reducing the total number of premature births to 9.6 by the year 2020, as the organization’s president, Dr. Jennifer L. Howse, discusses in this video about the report card:

March of Dimes: Fewer Premature Babies in the U.S.

Tuesday, November 1st, 2011

A new report from the March of Dimes has upgraded the United States to a “C” grade for premature births, an improvement from its previous rating of “D.”  The announcement was made to coincide with November as Prematurity Awareness Month.

CNN.com reports on the new findings:

Each year, the March of Dimes compares each state’s pre-term birth rate with the goal birth rate. The report says 40,000  fewer babies were born prematurely in the U.S. between 2006 and 2009.

“We set a goal of 9.6 % by 2020, and it’s a realistic goal we can get to and it would be a tremendous accomplishment,” says Douglas A. Staples,  senior vice president of strategic marketing and communications for the   March of Dimes. This year the state of Vermont was the only state to achieve that goal. The current nationwide rate is 12.2 percent.

…

A baby born before 37 weeks is considered premature and at serious health risk.  Being born earlier than 37 weeks is the leading cause of newborn death in the United States, costing more than $26 billion each year, according to the report. While the U.S. ranks first in health care spending, it is 39th in infant mortality, according to a 2006 report.

(image via: http://www.healthjockey.com/)