On Wednesday, the federal health advisers concluded that the injectable drug Makena should be withdrawn from the market despite the manufacturer’s appeal to use it on a drug requiring additional research criteria. The agency noted that the drug was intended to prevent premature births. However, they deemed the drug ineffective and called for its removal.

In 2011, Makena was granted FDA approval based on one small study that showed a reduction in the rate of premature birth in women with a history of the problem. But in 2019, the findings of an international study that included 1,700 patients showed the drug neither reduced premature births nor resulted in healthier outcomes for infants.

Dr. Yolanda Lawson, an obstetrics specialist at Baylor University, sided with the FDA panel but urged them to do what is best for the patients, which is to keep the medication available for doctors who manage such high-risk patients every day.

According to Covis Pharma, more than 350,000 women have used the drug in the last decade. The pharmaceutical company added that even though the drug has been removed from the market, several doctors may prescribe the key compound of the drug as a specialty medication. Since both Makena and the compounded medications contain a synthetic form of progesterone, which helps the uterus grow and maintain a pregnancy,