New Drug Reduces Preterm Birth
FDA Approves Makena to Reduce Risk in Women With History of Premature Delivery
The drug will be studied in follow-up research that will end in about 2018. That study is expected to include 580 to 750 infants.
The FDA originally approved hydroxyprogesterone caproate under the trade name Delalutin in 1956 for use in pregnant women with threatened miscarriage. The FDA says the original manufacturer requested that Delalutin be withdrawn from the market in 2000 for reasons not related to safety.
Alan Fleischman, MD, senior vice president and medical director of the March of Dimes, says in a news release that Makena will give hope to women who have delivered babies too soon that “their next child will have a better chance at a healthy start in life.”
He says women who have previously had a baby born prematurely should check with their doctors to see if Makena is appropriate for them, because it is “not for everyone.”
The statement says a study by the March of Dimes, the National Institutes of Health, and the CDC, using 2002 data, estimated that if all women eligible for the progesterone injections received them, about 10,000 spontaneous premature births might be prevented annually.
New Drug Lowers Preterm Birth Risk
FDA Approves Makena to Reduce Risk in Women With History of Premature Delivery
Makena: Weekly Injections continued...
The drug will be studied in follow-up research that will end in about 2018. That study is expected to include 580 to 750 infants.
The FDA originally approved hydroxyprogesterone caproate under the trade name Delalutin in 1956 for use in pregnant women with threatened miscarriage. The FDA says the original manufacturer requested that Delalutin be withdrawn from the market in 2000 for reasons not related to safety.
Alan Fleischman, MD, senior vice president and medical director of the March of Dimes, says in a news release that Makena will give hope to women who have delivered babies too soon that “their next child will have a better chance at a healthy start in life.”
He says women who have previously had a baby born prematurely should check with their doctors to see if Makena is appropriate for them, because it is “not for everyone.”
The statement says a study by the March of Dimes, the National Institutes of Health, and the CDC, using 2002 data, estimated that if all women eligible for the progesterone injections received them, about 10,000 spontaneous premature births might be prevented annually.