FDA withdraws approval of Makena

The Food and Drug Administration has decided to withdraw approval of Makena and generic versions of the drug, the agency announced April 6.

The medication was approved in 2011 to reduce the risk for preterm birth in women who had previously experienced spontaneous preterm birth. The treatment had been approved under an accelerated pathway that required another trial to confirm clinical benefit.

A postmarketing study did not show clinical benefit, however, and the agency proposed withdrawing the drug, hydroxyprogesterone caproate injection, in 2020. The drug’s sponsor requested a hearing on the decision, and that meeting was held in October 2022.

The FDA commissioner and chief scientist subsequently reviewed submitted reports, comments, and transcripts, and made the decision to withdraw the drug.

“Effective today, Makena and its generics are no longer approved and cannot lawfully be distributed in interstate 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 – particularly in light of the fact that this serious condition has a disparate impact on communities of color, especially Black women,” FDA Commissioner Robert M. Califf, MD, said in a statement.

Risks associated with the drug include thromboembolic disorders, allergic reactions, decreased glucose tolerance, and fluid retention, regulators have noted. The agency acknowledged that some supplies of the product have already been distributed. Patients with questions should talk to their health care provider, the FDA advised.

The Food and Drug Administration has decided to withdraw approval of Makena and generic versions of the drug, the agency announced April 6.

The medication was approved in 2011 to reduce the risk for preterm birth in women who had previously experienced spontaneous preterm birth. The treatment had been approved under an accelerated pathway that required another trial to confirm clinical benefit.

A postmarketing study did not show clinical benefit, however, and the agency proposed withdrawing the drug, hydroxyprogesterone caproate injection, in 2020. The drug’s sponsor requested a hearing on the decision, and that meeting was held in October 2022.

The FDA commissioner and chief scientist subsequently reviewed submitted reports, comments, and transcripts, and made the decision to withdraw the drug.

“Effective today, Makena and its generics are no longer approved and cannot lawfully be distributed in interstate 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 – particularly in light of the fact that this serious condition has a disparate impact on communities of color, especially Black women,” FDA Commissioner Robert M. Califf, MD, said in a statement.

Risks associated with the drug include thromboembolic disorders, allergic reactions, decreased glucose tolerance, and fluid retention, regulators have noted. The agency acknowledged that some supplies of the product have already been distributed. Patients with questions should talk to their health care provider, the FDA advised.

The Food and Drug Administration has decided to withdraw approval of Makena and generic versions of the drug, the agency announced April 6.

The medication was approved in 2011 to reduce the risk for preterm birth in women who had previously experienced spontaneous preterm birth. The treatment had been approved under an accelerated pathway that required another trial to confirm clinical benefit.

A postmarketing study did not show clinical benefit, however, and the agency proposed withdrawing the drug, hydroxyprogesterone caproate injection, in 2020. The drug’s sponsor requested a hearing on the decision, and that meeting was held in October 2022.

The FDA commissioner and chief scientist subsequently reviewed submitted reports, comments, and transcripts, and made the decision to withdraw the drug.

“Effective today, Makena and its generics are no longer approved and cannot lawfully be distributed in interstate 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 – particularly in light of the fact that this serious condition has a disparate impact on communities of color, especially Black women,” FDA Commissioner Robert M. Califf, MD, said in a statement.

Risks associated with the drug include thromboembolic disorders, allergic reactions, decreased glucose tolerance, and fluid retention, regulators have noted. The agency acknowledged that some supplies of the product have already been distributed. Patients with questions should talk to their health care provider, the FDA advised.