• 07
  • February
    2011

Premature delivery-delivery before 37 full weeks of gestation- occurs in one in eight babies born in United States. It increases risk of infant complications at birth, permanent disabilities and death. Over last 25 years, the rate of premature birth has increased 35%, and three-quarters of such births are late preterm births-born at 34 to 36 weeks.

Last week, the FDA approved the first drug for the prevention of premature delivery under its accelerated approval regulations. The drug is a reissue of an older version, and will be marketed under the name Makena (hydroxyprogesterone caproate).

Makena reduces the risk of premature delivery before 37 full weeks of pregnancy for women with history of at least one premature delivery. The FDA approved the drug only for women carrying one baby who previously gave premature birth to one baby. The drug is not approved for women carrying twins or who have other risk factors for premature delivery.

According to March of Dimes a spokesman, the most common risk factor for preterm birth is recurrence. The new drug is expected to dramatically lower the rate of premature delivery for these women

The new drug is chemically the same as the older Delalutin, which had been approved by the FDA in 1956 and later removed from the market in 2008 for financial reasons. The drug had been used to treat female hormone disturbances and cancer. Because the new drug will be manufactured by a drug company and not individual pharmacies, the consistency of quality will be much better and doctors will be more comfortable in prescribing it.

Makena is given an injection once per week from 16th to 37th week of pregnancy. Side effects are usually inconsequential, but some women may experience more serious ones, such as blood clotting in lungs and infections at the injection site.

The drug has reportedly been used for years for women at risk for preterm labor, and has almost come to be considered a standard of care in the last 6 years.

The FDA's terms of approval require the manufacturers to demonstrate though studies that Makena has a clinical benefit. The confirmatory study found that, out of 463 pregnant women, there were 18% fewer premature deliveries among those who took the drug compared to those who did not. The drug was not found to affect child development. Studies are ongoing.

Source: Bloomberg, "FDA Approves First Drug to Prevent Premature Births" Steven Reinberg," 4 Feb 2011.