A medication to prevent preterm birth was subjected to vote by the Food and Drug Administration (FDA) last week. The medication’s removal from the market was strongly recommended as advisers decided that there was not enough evidence to suggest that it works.
However, there are a few leading OB-GYNs that hope the FDA won’t agree to take the medication, named Makena, which is an artificial type of hormone progesterone, out of use. The vote panel was constructed of 16 people, containing physicians of numerous specialties and statisticians. They all agreed that the evidence collected on the medication does not show its effectiveness for its intended use. Some advisers hoped to leave it on the market for the moment to conduct more studies, while others believed it should be taken out of use.
Does it Actually Function?
By only two votes, the panel recommended the medication to be removed from the market. Makena was first approved by FDA for sale back in 2011, mostly based on discoveries of a 2003 research sponsored by the National Institutes of Health.
The research was comprised of 463 pregnant women who previously had a spontaneous preterm birth and were at a higher risk of having a second delivery of this type. The women were separated into two groups. A group was given progesterone, and the other received a placebo.
Women taking the medication were injected weekly, starting at 16 to 20 weeks of pregnancy and up to 36 weeks. The research showed that the treatment reduced the risk of preterm delivery at a significant rate.
“There was a 66% drop in the rate of recurrent preterm birth among women taking progesterone,” says Dr. Eva Pressman, chief of obstetrics and gynecology at the University of Rochester. “We think that progesterone acts as a uterine muscle relaxant, which seems to decrease the ability of the uterus to contract.”
Having the beneficial discoveries of the research, the medication’s approval process was accelerated, but it was given a major monition: Makena’s manufacturer was demanded to conduct wider research to confirm the medication’s benefit.
The follow-up research, published in October, discovered that Makena did not reduce repeated preterm deliveries.
The FDA’s advisory board was requested to review the proof and decide whether the benefits of the medication compensated any risks. The agency doesn’t have to do as the board advises, but, usually, it does.
Dr. Christopher Zahn, vice president for practice for the American College of Obstetricians and Gynecologists, believes the removal of Makena from the market would be wrong. He says that even though the follow-up research was made to be a supporting trial, there were some things that made it hard to clarify. The study was conducted on much more cases, but it included a way higher volume of women who were at low risk of preterm birth.
This makes clear comparisons of contradictory findings from two studies difficult and emphasizes a need for additional research.
Makena is the only drug available at the moment, which can prevent preterm delivery, Zahn explains and is now the regular medication administered to women who are at high risk of having a preterm birth.
“It’s one thing to have concern raised because of conflicting data,” he says, “but if that particular medication isn’t available, it no longer becomes an option,” he said.
Zahn worries that taking off the medication from the market could end up in an increase in premature births, which, in turn, creates numerous severe problems for babies.