- Federal regulators are currently debating whether to take the pregnancy drug Makena off the market.
- A panel of scientific advisors has recommended the drug be removed because they say it isn’t effective in preventing preterm birth.
- Makena was granted accelerated approval in 2011, but there have been discussions since then about its effectiveness.
The Center for Drug Evaluation and Research has
The FDA has granted a hearing on the matter that will discuss whether Makena effectively reduces preterm births and whether it should remain on the market for the completion of additional studies.
A panel of 15 federal advisors recommended in a 14-1 decision earlier this month that hydroxyprogesterone caproate (Makena) be taken off the market because it isn’t effective in preventing preterm birth. The panel indicated they could not identify women or groups of women helped by the drug.
The FDA granted accelerated approval for Makena in 2011. This
The FDA based its 2011 approval on a small study that appeared to reduce the rate of premature birth in women with a history of the problem. The approval was conditioned on a large follow-up study of around 1,700 women examining whether the drug resulted in healthier infant outcomes.
A more extensive study was completed in 2019. It reported that Makena did not reduce premature births or result in healthier outcomes. In 2020, the FDA deemed the medication ineffective and called for removing it from the market.
Covis Pharma, the manufacturer, isn’t ready to pull the drug. It challenged the 2020 decision, suggesting that its removal would leave women at the highest risk of early delivery without choices and called for additional research. This challenge led to the latest hearing, where the panel recommended removal from the market.
According to the manufacturer, around 350,000 women have used Makena in the past decade.
Some experts argued that removing the drug would worsen racial disparities in prenatal care. Covis Pharma suggested narrowing approval to those who would most benefit from the drug.
“Makena is one brand of progestin (synthetic progesterone) that has been offered over the last decade,” said Dr. Jessica Daigle, a pediatric hospitalist and the founder and chief executive officer of Mom & Me MD, an in-home and virtual concierge practice in Atlanta.
“It has been used to reduce the risk of premature births and while some women may have benefited (I believe it helped me in my pregnancy), recent studies show it may not be as effective at preventing preterm birth as previously hoped,” Daigle told Healthline.
Some doctors may continue prescribing the key ingredient through compounding pharmacies, which offer formulations of the drug. Both Makena and the compounding pharmacies contain progestin, which helps the uterus grow to maintain a pregnancy.
“I have prescribed this medication sparingly,” said Dr. Darren Salinger, an obstetrician-gynecologist specializing in routine and high-risk obstetrics and gynecology at Kidz Medical Services in Florida. “But, I didn’t feel it had much medical value. It wasn’t dangerous, but the research did not support it working.”
“That said, I am not sure it should come off the market. If there is a chance to help people have a healthy birth, we should use all available resources,” Salinger told Healthline.
“Preterm or premature birth is defined as a birth under 37 weeks gestation, with a full-term birth being 37 to 40 weeks gestation,” said Daigle.
In 2020, the preterm rate in the United States was 10 percent, according to the
However, there are differences along racial lines. Among Black women, the rate was 14 percent. Among white women, the rate was 9 percent. Among Hispanic women, the rate was almost 10 percent.
“A preterm infant (depending on how premature) can be born with all organ systems underdeveloped,” said Daigle. “Premature infants are at risk for issues with the brain, heart, lungs, gastrointestinal tract, blood (anemia), and immune system (infection).”
“There can be associated defects from being born early and malfunction of organ systems leading to breathing problems, feeding difficulties, temperature control issues, and growth concerns. There is also a risk of developmental delay and a small risk of cerebral palsy,” she added.
Experts say there are numerous ways to reduce or prevent preterm birth.
“The first step is to determine if someone is actively in preterm labor or if there is a risk because of their health history,” said Salinger. “This requires a physical exam and a discussion about their health history and previous pregnancies.”
Risk factors for preterm birth include:
- Incompetent cervix
- Anatomical differences with the uterus
- Multiple pregnancies
- Chronic conditions, such as diabetes and high blood pressure
Once the reason is understood, steps such as treating an infection or increasing fetal monitoring can be taken.
“There are some ways to maximize positive outcomes. For example, someone might benefit from additional rest, limiting work activities, such as not lifting, bending down, or standing for long periods,” said Salinger. “Some women might benefit from better nutrition. Some might need antibiotics. If the baby isn’t developing, steroids might help.”
“Another tool is a fetal fibronectin test. A negative result indicates a low chance of delivery within the next two weeks. A positive result indicates a high risk of delivery within the next two weeks. This test is very helpful in monitoring potential early deliveries,” he added.