According to a US Food and Drug Administration advisory committee, a drug used to reduce the danger of a mother experiencing a preterm birth should be removed from the market. This drug, Makena, supposedly isn’t effective. The committee voted 9-7 to have the drug withdrawn.
Risks May Outweigh Effectiveness
The FDA isn’t required to follow the committee’s advice, but it often does so. Makena was approved by the FDA back in 2011. This medication is a progestin hormone, which is given by injection. It is usually prescribed to women who have a history of preterm birth to reduce the risk. However, it doesn’t work for women who have already begun premature labor or for women who are pregnant with twins, triplets or more.
Makena is one of the few treatment options for women with a history of preterm births. The active ingredient is the only treatment approved by the FDA for women who have had at least one previous preterm birth.
This medication does come with many restrictions. It shouldn’t be given to pregnant women who have had breast cancer, liver issues, unusual vaginal bleeding, a history of clots or uncontrolled high blood pressure. One study showed an indication of more miscarriages in women who were taking Makena. There were also more stillbirths, gestational diabetes, preeclampsia and oligohydramnios (low levels of amniotic fluid).
Pregnancy complications are considered a common side effect with Makena. This means up to 10 percent of people taking the drug could experience these complications.
Other common side effects include pain and swelling at the injection site. Patients have also experienced urinary tract infection, a shortened cervix and cervical dilation. Nausea and diarrhea are common as well.
Preterm birth is also known as premature birth. It can be caused by a long list of risk factors, including the following:
- Previous preterm birth
- Pregnant with multiple children
- Age of pregnant mother is below 17 or above 35
- Diabetes or high blood pressure
- Multiple miscarriages
- In vitro fertilization
- Less than six months between pregnancies
- Cigarette smoking
- Drinking alcohol
- Birth defects in baby
- Trauma
- Prolonged stress
- Issues with the placenta, cervix or uterus
- Infection of amniotic fluid
Preterm Risks
Preterm birth is defined as a baby that is born more than three weeks early. This condition occurs in 1 of 10 births in the US, according to the Centers for Disease Control and Prevention (CDC). The numbers are declining from statistics in the early 2000s. However, they have been rising since 2014.
The rate of preterm births is higher for certain ethnicities than for others. Babies that are born preterm haven’t had the chance for their lungs, liver and brain to develop, which usually happens in the final weeks of pregnancy. A preterm baby is at a higher risk for breathing issues, developmental delays and problems with vision. They may also be at a greater risk for cerebral palsy and other health conditions.
Preterm labor often begins unexpectedly, so it is difficult to prevent. However, doctors will monitor closely for anyone who has known risks for early birth.