Evaluating the safety of hydroxyprogesterone caproate is essential to ensure patient safety justifies its use. The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) recommended suspending the marketing authorizations for medicines containing 17-hydroxyprogesterone caproate (17-OHPC) in the EU. This decision stems from a review indicating potential cancer risks and lack of efficacy in preventing premature births.
The PRAC concluded that there is a possible but unconfirmed risk of cancer in individuals exposed to 17-OHPC in the womb. Additionally, new studies revealed that 17-OHPC is not effective in preventing premature births. The data on its effectiveness for other approved uses are also limited. In light of these concerns, the PRAC determined that the benefits of hydroxyprogesterone caproate do not outweigh its risks, leading to the recommendation to suspend its marketing authorizations.
In some EU countries, 17-OHPC medicines are approved as injections to prevent pregnancy loss or premature birth in pregnant women. They are also authorized to treat various gynecological and fertility disorders caused by a lack of the hormone progesterone. However, given the cancer risk and ineffectiveness, the PRAC’s suspension recommendation underscores the necessity of prioritizing patient safety.
PRAC Recommends Suspension of Hydroxyprogesterone Caproate Medicines and Issues DHPC to Healthcare Professionals
The PRAC also discussed direct healthcare professional communication (DHPC) regarding hydroxyprogesterone caproate medicines. The DHPC aims to inform healthcare professionals about the suspension recommendation and advise them to consider alternative treatment options. Once approved, the DHPC will be disseminated by the marketing authorization holders to healthcare professionals across the EU, ensuring widespread awareness and adherence to the new guidance.
The suspension of 17-OHPC medicines emphasizes the importance of continuous monitoring and evaluation of medical products to protect patient health. This proactive measure by the PRAC reflects the commitment to maintaining high safety standards in the EU healthcare system.
The agenda of the PRAC meeting held from May 13-16, 2024, included various discussions on the safety and efficacy of different medical products. The PRAC statistics for May 2024 highlight the scope and scale of the committee’s activities in monitoring and assessing drug safety. The glossary provided in the PRAC’s documentation explains key terms and procedures used in their assessments, such as safety signal assessments, periodic safety update reports (PSURs), risk management plans (RMPs), post-authorization safety studies (PASSs), and referral procedures.
PRAC Suspends Hydroxyprogesterone Caproate Medicines to Ensure Safety and Efficacy in the EU
The PRAC’s decision to suspend 17-OHPC medicines is one of many steps taken to ensure that all medical products available in the EU meet stringent safety and efficacy standards. This decision is based on thorough scientific evaluations and underscores the necessity of evidence-based medicine in regulatory practices. The EMA will continue to monitor the safety of hydroxyprogesterone caproate and other medical products through its established pharmacovigilance processes. Healthcare professionals and patients are encouraged to report any adverse effects or concerns with medications to ensure that potential risks are identified and managed promptly. The PRAC’s actions demonstrate the importance of rigorous oversight in the pharmaceutical industry to safeguard public health.
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The continuous assessment and reevaluation of medical products like hydroxyprogesterone caproate are crucial for maintaining a safe and effective healthcare system. By prioritizing patient safety and ensuring that treatments provide real benefits, regulatory bodies like the PRAC play a vital role in protecting public health.
Resource: European Medicines Agency, May 17, 2024
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