Makena, Proluton Exposure Before Birth May Increase Cancer Risks Later In Life: Study

New research suggests the side effects of Makena, Proluton and other similar drugs previously used to prevent miscarriages, may increase the risk children exposed before birth may face an increased risk of cancer later in life.

Preliminary findings of a study were presented last week at the annual meeting of The Endocrine Society, indicating children born to women who received miscarriage-prevention drugs which contain hydroxyprogesterone caproate, also known as OHPC or 17-OHPC, had upward of five times the risk of developing colon and rectal cancers when compared to the children of mothers who did not take the drug.

Hydroxyprogesterone Caproate is a man-made endocrine-disruptor prescribed to mothers during the 1950’s and 1960’s to reduce the chances of miscarriage. While the drug is no longer prescribed to specifically prevent miscarriages, it is currently sold under the brand names Makena and Proluton and advertised to help the uterus grow and prevent preterm contractions.

According to the findings presented at the annual conference, researchers reviewed prenatal care records collected by the Kaiser Foundation Health Plan between June 1959 and June 1967 and cross referenced those records with the California Cancer Registry, which tracked cancer diagnosis in children up through 2018.

The findings indicate the offspring of the 181 women given drugs like Makena or Proluton during pregnancy faced an increased risk of developing all cancer types, and were overall twice as likely to be diagnosed with at least one type of cancer in adulthood when compared to children whose mothers did not take the drug.

Researchers indicate the children exposed to the man-made hormone had nearly five times the risk of specifically developing colon and rectal cancers and upwards of four times the risk of developing prostate cancer during younger stages of adulthood when compared to the children of mothers not prescribed OHPC.

While the study was not designed to offer a theory on why the drug may increase the risk of children developing cancer later on in life, researchers noted there is significant statistical association with an increased risk of cancer diagnosis. The findings are considered preliminary until published in a peer-reviewed journal.

Makena Efficacy Worries

Makena (hydroxyprogesterone) was introduced in 2011, and is the only medication approved for prevention of preterm birth in women who had a prior spontaneous preterm birth. However, recent studies have raised questions about whether the drug actually works.

This latest study was presented just months after the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) sent a Notice of Opportunity for Hearing to the manufacturers of Makena and its generic equivalents on October 5, proposing to withdraw approval of the drug after postmarketing studies have failed to show a clinical benefit.

In addition to lacking any tangible benefit, the FDA warned Makena side effects may increase the risk of pulmonary embolism, blood clots, allergic reactions, decreased glucose intolerance, fluid retention, and could worsen some conditions commonly experienced by pregnant women, including preeclampsia and depression.

Concerns about Makena problems arose following the results of a clinical trial, Progestin’s Role in Optimizing Neonatal Gestation (PROLONG), which found that the drug simply does not work; failing to show any clinical benefits.

In early October 2019, the consumer watchdog group Public Citizen called for a Makena recall in a petition to the agency, saying it did not make sense for the synthetic hormone to remain on the market to be injected into pregnant women, who would then face the risk of side effects without any apparent benefits.

That same month, the FDA convened an advisory committee meeting, which voted unanimously that Makena appeared ineffective, and nine of its 16 members voted for the drug to be pulled from the market.

A year later, in October 2020, the FDA’s Center for Drug Evaluation and Research (CDER) called for Makena to be removed from the market. However, it is currently still available.