There are plenty of health-related concerns for pregnant women to worry about over the course of nine months. Toward the end, the main concern is arguably preterm birth or delivering the baby more than three weeks before the due date. The effects of premature birth on a baby range from brain issues to bowel problems. The more preterm the baby is born, the more severe these complications may be. That being said, preventing such a situation from taking place is a high priority for both doctors and pregnant women alike.
Enter Makena, a drug designed to do exactly this. But is it too good to be true?
Vote for Makena withdrawal
Recently the US Food and Drug Administration (FDA) has called for the approval of this drug to be withdrawn. A 9-7 vote among the Bone, Reproductive and Urologic Drugs Advisory Committee is reflective of concerns that the drug is ineffective. Those who voted against its withdrawal all agreed to "leave Makena on the market under accelerated approval and require a new confirmatory trial." In other words, all committee members agree that something needs to be changed regarding Makena on the market, whether that be complete removal or more clinical testing.
Did approval pass too soon?
In 2011, the drug was approved by the FDA under “accelerated approval”, meaning that it was approved before there were actual proven benefits. The drug, which is an injection of progestin hormone, is geared toward women who have had a spontaneous preterm birth in the past and therefore are more likely to undergo one again.
Many people are advocating for the drug to be pulled from the market because of how it was approved, or more specifically, how little evidence was presented when it was. They are calling for more clinical trials to confirm the results and benefits of the drug. Those who are in favor of the drug point to the years of success it has had helping women prevent preterm labor. While these success stories are anecdotal and not backed by trial, they may raise difficulty when one is trying to take a firm stance on the drug.
When it comes to your health, especially while pregnant, it’s extremely important to do proper research and understand what your options are. Working closely with your doctor can help assure that you are up to date on the newest medical news and knowledge. Toward the end of pregnancy, you will definitely want to do everything you can to safely and successfully guarantee the delivery of a healthy, happy baby. Whether that calls for Makena or not, only time will tell.