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March of Dimes urges FDA drug approval
Filed under: Your Pregnancy, Places To Go, Development/Milestones: Babies
In a news release today, the March of Dimes urged Food and Drug Administration officials to promptly approve a commercial progesterone therapy that appears to prevent some premature births. Dr. Nancy Green, March of Dimes medical director, testified before the FDA Advisory Committee for Reproductive Health Drugs, which met to discuss "Gestiva," also known as 17 alpha-hydroxyprogesterone or 17-P. "Studies of progesterone injections offer promise that the risk of recurrent preterm births will be reduced in a select group of women who already had a baby born too soon," said Dr. Green. "We hope the FDA will approve the licensing of this drug so those women can be helped by this treatment." Nationwide, nearly a half million babies are born too soon each year and babies who survive face risks of lifelong developmental challenges, such as cerebral palsy, mental retardation, chronic lung disease, and vision and hearing loss. The Institute of Medicine estimates the national cost of premature birth in 2005 exceeded $26 billion. Progesterone is given as weekly injections during the second half of pregnancy. FDA approval is needed before the drug can be widely available in pharmacies and covered by Medicaid.
A large study found that for women who had a previous premature baby 17-P reduced the preterm birth rate by 33 percent compared to a control group. The March of Dimes estimated that if all women eligible for the progesterone therapy had received it, nearly 10,000 premature births might have been prevented in 2003. While there is no evidence that 17-P has an adverse effect on infants, the March of Dimes remains cautious about its use and is concerned that women without a previous premature baby are receiving the injections. This may be of special interest to those mothers who want to have more children, but are reluctant because they had a premature child in the past.
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ReaderComments (Page 1 of 1)
9-01-2006 @ 5:45PM
Michelle said...What a wonderful advancement. March of Dimes is a worthwhile organization, without which my son, and many other babies would not be here today! I'm glad they are being cautious with this newfound *vaccine*. I just wish they could have come up with it a little sooner. My hubby went to the vet to get fixed 2 days after our preemie came home so we wouldn't have to go through the same heart-wrenching experience all over again. (You should have seen him when we had a pregnancy scare about 6 mos ago. Can you say panicked?)
Anyway, I'm happy that the research has been done to try to find a *cure* for recurring premature births. Hopefully, one day premature babies will be something we discuss in the past-tense. It would be wonderful if my daughter wouldn't ever have to worry about her baby being born too early. ( In, at least another 20 years, when her daddy finally puts the shotgun away and lets her date!)
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9-01-2006 @ 6:36PM
Ethel said...Good golly the use of progesterone to prevent early labor is not a new technique - first used in race horses and then in women. Actually, the first trials of birth control pills in the US were purportedly for maintaining pregnancy (since birth control was too radical, but thank God for Margaret Sanger). Check out "Napoleon's Button's", one of the chapters talks about steroids and spends some time on progesterone and estrogene.
The biggest issue with this is not many companies want to even think about producing artificial hormones to prolong pregnancy - just not cost efficient (as in, no big buck like Viagra).
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9-02-2006 @ 9:24AM
Anne said...I know many women who have used this to prevent early births, and PROM pregnancies. it works, and saved many families from the heartache of a baby born too soon. Many PROM moms lose their child at birth. This helps subsequent pregnancies end on a happy note- with a live baby. www.kanalan.org/prom
Anne
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9-03-2006 @ 9:29AM
Brenda said...I just wanted to add that in some cases PROM can be prevented through nutrition. But because eating right and basic vitamins do not have large lobby groups this message doesn't seem to be getting out.
http://www.findarticles.com/p/articles/mi_m0887/is_5_24/ai_n13795376
I am glad that more research is being done though, because both my aunts children were premature so I know the heartbreak. Luckily my first was 41week + 1day.
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