The U.S. Food and Drug Administration (FDA) has announced the voluntary withdrawal of Makena, a medication used to reduce the risk of preterm birth in certain pregnant women. This decision comes after a review of clinical data showed that the drug’s benefits did not outweigh its risks.
Makena, also known as hydroxyprogesterone caproate, was approved by the FDA in 2011 as a treatment for women with a history of preterm birth. It was the only drug of its kind on the market at the time, and it quickly became a standard of care for high-risk pregnancies. However, since its approval, there has been ongoing debate over its efficacy and safety.
The FDA’s review of data from several clinical trials found that Makena did not significantly reduce the risk of preterm birth in women with a history of the condition. Additionally, the drug was associated with a higher risk of side effects, including injection site reactions, nausea, and vomiting. There was also concern about the drug’s impact on fetal development and the potential for long-term harm.
The announcement has sparked concern among healthcare providers and patient advocacy groups, who worry that the withdrawal of Makena will leave high-risk pregnant women with limited options. However, some experts argue that there are alternative treatments available that may be more effective and safer.
Dr. Uma Reddy, a maternal-fetal medicine specialist at the University of Michigan, said, “We have been concerned about the lack of evidence supporting the use of Makena for many years. While it is important to have options for preventing preterm birth, we need to ensure that those options are based on sound science.”
The FDA’s decision to withdraw Makena from the market highlights the need for continued research and development of safe and effective treatments for preterm birth. It also underscores the importance of evidence-based medicine and the need to carefully weigh the benefits and risks of any medication before it is approved for use.
As for now, the withdrawal of Makena will take effect after a six-month period, during which the drug’s manufacturer will have the opportunity to submit any data or information that might persuade the FDA to reconsider its decision. In the meantime, healthcare providers and patients are advised to discuss alternative treatment options with their doctors.