Makena Recall Urged By Public Citizen Due To Lack of Effectiveness Preventing Preterm Births

A consumer watchdog group is calling for federal regulators to recall Makena, after clinical trials found that the medication is not effective at preventing preterm births, which may result in unnecessary side effects.

In a Makena recall petition (PDF) filed with the FDA earlier this month, the advocacy group Public Citizen indicated the agency should withdraw approval for the medication. The request comes ahead of an FDA regulatory meeting scheduled for October 29, where Makena’s effectiveness will be reviewed.

Makena (hydroxyprogesterone) is an AMAG Pharmaceuticals drug, which was approved by the FDA in 2011 for prevention of preterm birth in women who had a prior spontaneous preterm birth. It is the only medication approved for this use, but a post-marketing clinical trial previously required by the regulatory agency has shown that the drug is not effective for its intended purpose.

The Public Citizen petition indicates that an FDA-mandated postmarket clinical trial for Makena failed to show the drug provided clinical benefits. Public Citizen states the clinical trial not only failed to show a reduction in the risk of preterm births, but it also failed to show a decreased risk of fetal and neonatal morbidity or mortality. Public Citizen claims the initial clinical trial which led to FDA approval was also “seriously flawed.”

“I counsel pregnant women every day on the issue of preterm birth and have lots of experience delivering very premature babies,” Dr. Adam C. Urato, chief of maternal-fetal medicine at MetroWest Medical Center in Framingham, Mass., and a co-petitioner with Public Citizen said in a press release. “It makes no sense to inject women with a synthetic hormone that carries risks – including injection site reactions, possibly increased rates of gestational diabetes and the unknown long-term adverse effects to the baby – but offers no meaningful benefits. The FDA must pull this product off the market.”

Late last month, the FDA issued a federal register notice (PDF) announcing a meeting of the agency’s Bone, Reproductive and Urologic Drugs Advisory Committee Meeting to discuss the ramifications of the failed clinical trial.

“AMAG Pharmaceuticals has disclosed that this completed confirmatory trial did not demonstrate a statistically significant difference between the treatment and placebo arms for the co-primary endpoints of reducing the risk of recurrent preterm birth or improving neonatal mortality and morbidity,” the FDA notice indicates.

The FDA is not required to heed the advisory committee’s recommendations, however they do weigh heavily in the agency’s final rule decisions.