A new study led by a team of researchers from the University of Texas Southwestern Medical Center revealed that makena, the only drug the U.S. Food and Drug Administration (FDA) has approved for staving off recurring premature births, may not be effective.
The FDA approved makena in 2011 and 17-alpha-hydroxyprogresterone caproate (17P) is its chemical compound name.
Since the drug was approved, it has been endorsed nationwide by the Society for Maternal-Fetal Medicine and American Congress of Obstetricians.
In January, it was deemed an effective drug by the Society for Maternal-Fetal Medicine, whom continued to recommend it even though 17P was under utilized.
The recent study lasted over a four-year-span beginning in January 2012 and ending in March 2016. Over the course of the trial, 430 women who had previous premature births were administered 17P.
The women began a 17P drug regimen at 16 weeks of gestation and received weekly injections through 20 weeks of gestation.
The average recurrent preterm birth rate is 16.8 percent at the Parkland Hospital. To compare preterm birth rates, the researchers matched the participants’ preterm birth profiles with similar profiles in the historical cohort. A total of 430 participants were matched with 1,290 mothers in the historical control, based on the demographic factors, including body mass index, pregnancy history and race.
The researchers discovered that 17P did not considerably decrease the recurrent preterm birth rates, even after the researchers controlled for those demographic factors. In fact, the rate of reoccurrence was actually higher for the study group, which was treated with 17P injections at 25 percent.
The research team noticed similar or higher recurrence preterm birth rates in the 17P study group when compared to the mothers in the historical control for all the specific pregnancy history. The recurrence rate was 31 percent for mothers with a single prior preterm birth in the 17P group when compared to the historical control at 18 percent.
The recurrence rates were statistically similar for both the historical cohort and the 17P study group among mothers with three or more preterm births.
The researchers analyzed blood draws from the women who received 17P injections and discovered that 13.4 percent of the women were diagnosed with gestational diabetes compared to eight percent in the historical control. The findings revealed that 17P is ineffective at worst or at best and could be associated with a higher likelihood of birth complications.
A 2003 study conducted by professor Paul J. Meis at Wake Forest University helped to push Makena (17P) through the FDA approval process, allowing the drug to receive an accelerated approval.
The paper’s publication has also raised questions, which did not contain the findings of the first phase, even though the study was completed in two phases. It was later reported that the preterm birth recurrence rate was reported at 36 percent in the control group.
The second phase results revealed a recurrence rate of a much higher 55 percent, which lead to speculation that the way the preterm birth recurrence rates were compared determined the outcome of the study. This gave the impression that 17P was effective in preventing recurrent preterm births.
The mechanisms of progestogens like 17P are still unclear. It was once believed that progestogens were capable of preventing inflammation in the uterine cervix. However, this has recently been disproven and in fact, progestogens are not associated with decreasing the likelihood of uterine contraction.
Lumara Health, a pharmaceutical company formerly known as KV Pharmaceutical, purchased the rights to market and manufacturer 17P under the Makena brand on the basis of the 2003 study.
In February 2011, Lumara Health announced it would increase the price of the drug from $20 to $1,500 per injection, since it faced no competition. Later the same year, the company decreased the price of the drug to $690 per injection. According to reliable resources, the company is currently selling the drug at $767.98 per injection. However, 17P can be purchased from various pharmacies in America for $10 to $25, despite the company’s price gouging.
The FDA continues to recommend Makena for prevention of reoccurring preterm births except in cases when the patient has a medical condition or allergy that prevents consumption.
The study was published in the American Journal of Obstetrics and Gynecology in March 2017.