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Makena Pregnancy Drug Approval Withdrawn by FDA

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Drug found to be ineffective, risks outweigh benefits

Tuesday, October 6, 2020 - inside courtroom

The acting director of the U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER), Patrizia Cavazzoni, M.D., has issued withdrawal of FDA approval for Makena, a drug used to prevent pre-term labor. According to a letter issued to AMAG Pharma USA, Inc., aftermarket studies show that the drug is not effective, and that the risks outweigh the benefits.

Makena was originally fast-tracked for approval in 2011 based on a limited study. Since then, additional studies found that it is no more effective than a placebo, and that it carries risks of thromboembolic disorders, lowered glucose tolerance, allergic reactions, and fluid retention that may worsen pre-eclampsia, depression, and adverse reactions at injection sites.

According to the letter, "The risk of exposing treated pregnant women to these harms, in addition to false hopes, costs, and additional healthcare utilization outweighs Makena's unproven benefit."

Several other withdrawals were issued to pharmaceutical companies Eugia Pharma Specialties Limited, Slayback Pharma LLC, Aspen Pharma USA Inc., American Regent, Inc, and Sun Pharmaceuticals Industries Ltd for their products containing hydroxyprogesterone caproate, the active ingredient in Makena. Drug approvals for their medications were pre-empted on AMAG Pharma USA, Inc.'s approval for Makena and based on the pre-approval study.

The letter reads, "First, and most important, an approved drug product should only be permitted to remain on the market if the benefits of its continued availability outweigh its risks. When a post-market clinical study fails to verify clinical benefit, the benefit/risk assessment that supported initial approval of the product changes significantly; when this occurs, expedited withdrawal is generally in the public interest."

AMAG Pharma USA, Inc. and the other pharmaceutical companies with drugs containing hydroxyprogesterone caproate will have an opportunity to submit requests for hearings regarding their approval status. CDER then has the option of granting or denying a hearing. If no further action is taken, the drugs will be recalled.

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