10 Apr 2023 • The US Food and Drug Administration announced its final decision to withdraw its approval of Makena, a drug approved more than a decade ago to reduce the risk of preterm birth that had been the only medication approved for the condition. The FDA says that the drug is not effective and that the benefits of taking it do not outweigh the risks.

The medication was approved in 2011 to reduce the risk for preterm birth in women with a previous spontaneous preterm birth. A postmarketing study did not show clinical benefit, however, and the agency proposed withdrawing the drug, hydroxyprogesterone caproate injection, in 2020.

Risks associated with the drug include thromboembolic disorders, allergic reactions, decreased glucose tolerance, and fluid retention, regulators have noted. "Effective today, Makena and its generics are no longer approved and cannot lawfully be distributed in commerce," the agency said.

"It is tragic that the scientific research and medical communities have not yet found a treatment shown to be effective in preventing preterm birth and improving neonatal outcomes" FDA Commissioner Robert M. Califf, MD, said in a statement about the decision.

Source: CNN Health | Read full article