In a significant blow to patient safety, the UK’s Prescription Medicines Code of Practice Authority (PMCPA) has publicly reprimanded Theramex, a leading producer of hormone replacement therapy (HRT) medications including Evorel and Intrarosa. The regulator cited “systemic failures” within the company, highlighting alarming breaches in compliance that have gone unchecked for years, including the failure to update vital prescribing information and a lack of clarity regarding the use of these drugs during pregnancy.
Serious Compliance Breaches Exposed
The PMCPA’s investigation was prompted by whistleblower reports from within Theramex, which revealed critical lapses in the company’s adherence to safety standards. Notably, the prescribing documentation for Evorel, a transdermal patch containing estradiol, had not been adequately updated for several years, raising concerns about the potential risks to patients.
Evorel patches are among the most commonly prescribed forms of HRT in the UK, with over 250,000 prescriptions issued in the most recent financial year. Across all forms of estradiol, nearly 10 million prescriptions were recorded in the 2024/25 period, underscoring the widespread reliance on these medications. The PMCPA found that Theramex had failed to provide comprehensive information about possible side effects and had not amended Intrarosa’s product information since 2019.
PMCPA’s Findings and Broader Implications
The PMCPA’s findings were damning, with the authority identifying 21 instances of non-compliance with the Association of the British Pharmaceutical Industry (ABPI) code of practice. These breaches not only jeopardise patient safety but also undermine public confidence in the pharmaceutical sector as a whole.
The authority specifically called out Theramex for not clarifying in its promotional materials that Yselty, a medication for uterine fibroids, should not be taken during pregnancy. This oversight is particularly concerning given the potential risks involved for expectant mothers and their unborn children.
In a further critique, the PMCPA condemned Theramex’s decision to withdraw from the self-regulatory framework, which would have provided additional oversight and accountability. “By leaving the self-regulatory framework and requiring the Medicines and Healthcare products Regulatory Agency (MHRA) to assume full responsibility for regulating it, Theramex has inevitably delayed any regulatory action and oversight,” the PMCPA noted.
Industry Reactions and Future Oversight
Dr. Amit Aggarwal, medical director of the ABPI, expressed disappointment over Theramex’s actions, stating that the company had fallen short of expected standards. He welcomed the PMCPA’s decision to take action, emphasising the importance of maintaining rigorous compliance within the pharmaceutical industry.
Meanwhile, Julian Beach, executive director of the MHRA, echoed these sentiments, asserting that the agency would remain vigilant in ensuring patient safety. He clarified that Theramex’s departure from the PMCPA jurisdiction would not shield the company from scrutiny, as the MHRA possesses the legal authority to investigate potential breaches that could endanger public health.
In response to the allegations, Theramex issued a statement asserting its commitment to ethical practices and patient safety. The company indicated that it had initiated a comprehensive review of its compliance processes and commissioned an independent audit to enhance its regulatory framework. In January 2026, Theramex opted to align itself with the MHRA rather than the PMCPA, a move the company believes will allow for a more focused approach to maintaining high ethical standards.
Why it Matters
The PMCPA’s reprimand of Theramex serves as a stark reminder of the critical need for accountability in the pharmaceutical industry. With millions of patients relying on HRT products, ensuring that companies adhere to strict safety guidelines is paramount. This incident not only exposes significant lapses in regulatory compliance but also highlights the vital role of whistleblowers in safeguarding public health. It is imperative that the industry, regulators, and patients remain vigilant to prevent such oversights from jeopardising patient safety in the future.
