FDA may withdraw the only medication to prevent preterm birth.

The only drug to prevent premature births may be pulled by the FDA.

The only drug to prevent premature births may be pulled by the FDA.

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The newborn baby inside the incubator in the hospital post-delivery room

The only medication is currently available to stop preterm births may soon be taken off the market because authorities believe it to be ineffective. Two years ago, the Swiss company Covis Pharma’s medicine Makena was deemed useless by the Food and Drug Administration (FDA).

The corporation is contesting the agency’s decision and is attempting to keep the medicine on the market; a three-day hearing is currently underway. In 2011, it was approved as part of the agency’s rapid approval procedure after a trial showed it helped stop preterm delivery in women with a history of it.

Since then, the medication has received greater attention. In recent years, the FDA discovered that Makena injections were ineffective in reducing the prevalence of preterm births. Its use did not result in lower rates of preterm birth or healthier outcomes for the baby, according to a 2019 study.

The FDA wants it removed because it can give some women false hope and divert funds from more productive uses onto a treatment that won’t work.

The main American obstetrics organization’s support for keeping the ten-year-old medication available while more study is conducted is complicating the Makena discussion. In the US, 10% of deliveries occur before 37 weeks, which increases the likelihood that the child will experience major health issues or perhaps pass away.

Makena, an injectable medication, might soon be taken from US shelves. This week, the FDA is holding hearings to evaluate the drug’s future after a 2019 research revealed that it had little effect on preventing preterm deliveries or improving the health of newborns.

The FDA officials and business scientists will present arguments for and against the medicine Makena in a setting like a judicial trial. A group of independent specialists will vote on the drug’s future on Wednesday.

Agency executives will eventually decide whether to issue a withdrawal order. The American College of Obstetricians and Gynecologists declares that “there is a considerable need for an effective treatment for preterm birth.”

To help prevent this problem, “Makena and its accompanying generics” are the only treatments currently accessible to obstetricians and gynaecologists.

The FDA issues a warning that mothers using the medication in the hopes that it may improve their pregnancy health may not receive any benefit. Makena is not demonstrated to be effective, according to the evidence presented today, said FDA’s drug chief Dr Patrizia Cavazzoni in her opening remarks on Monday.

It should be removed from the market because of its negative benefit and risk profile. In the US, about 10% of newborns are preterm. Makena, according to the FDA, “gives many expectant mothers false hopes.”

The risks that premature delivery presents to infants Premature labour, which is defined as a delivery before 37 weeks, occurs in about 10% of all pregnancies globally. The baby’s organs, such as the heart and lungs, won’t have fully formed by this time. They could also be undersized and underweight.

This may indicate that preemies “are not ready for life outside the womb,” according to Tommy’s, a charity in the UK.

According to statistics, the leading cause of infant mortality in the US and the UK is premature birth.


In the UK, premature birth accounts for about 1,500 deaths yearly. Premature birth and associated complications are responsible for 17% of infant deaths in the US. Prematurely born infants are frequently rushed to neonatal intensive care units, where they receive round-the-clock care.

How likely are you to survive?

  • Nearly little probability of life is possible in less than 22 weeks.
  • 22 weeks equals roughly 10%
  • 60% of the time is 24 weeks.
  • 27 weeks equals roughly 89%.
  • approximately 95% of the time is 31 weeks.
  • 34 weeks corresponds to a baby being born at full term.

The dispute is probably going to make people look more closely at the agency’s purported fast approval programme. In the meantime, more, typically larger studies are done, allowing medications like Makena to go on sale based on promising early results.

According to Washington University of St. Louis food and drug law expert Rachel Sachs, “Makena is being cited as an example of the many various objections of this programme.” Although it may not be fair to other medications, illnesses, or patient groups, we are compelled to act in the circumstances it creates.

In 2011, the FDA authorised Makena based on a short trial that suggested it decreased the incidence of premature delivery in women who had a history of early deliveries. The progesterone hormone, which promotes uterine growth and maintains pregnancy, is present in Makena in a synthetic form.

After 16 weeks of pregnancy, women can begin the shots. This month, the FDA issued briefing notes that stated that keeping Makena on the market “incurs false hopes, the hazards associated with treatment, and other burdens” like excessive medical expenses.

A new federal investigation states that since 2018, Makena has cost the US $700 million through various government programmes like Medicaid and Veterans Affairs. Numerous generic versions of the injection are likewise covered by the FDA’s ruling.

The pharmaceutical company contends that Makena is efficient and that the 2019 study’s shortcomings disguised its advantages.

The business notes that although Black women have a higher risk of giving birth prematurely, they only represented 7% of women in the international study, compared to 59% in the initial U.S. study that was utilised for approval. It needs more time to conduct new research on higher-risk individuals, especially Black Americans.

Similar points have been made in letters to the FDA by the Preterm Birth Prevention Alliance, a patient organisation that Covis funded. The business said in an email statement that “we think there is no reasonable public health justification” to deny patients and doctors access to Makena.

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