A major British supplier of menopausal HRT treatments has been sanctioned after whistle-blowers claimed patients were being put at risk, and alleging, among other things, that some products featured inaccurate prescribing information, reports The Independent.
The group of employees from Theramex, which supplies HRT treatments to millions of patients in the UK, wrote to the pharmaceutical regulator Association of the British Pharmaceutical Industry over allegations the company was not following regulatory standards and may “jeopardise” patient safety. They also said common side effects were not highlighted on product information, and their efforts to raise issues internally were brushed off.
The company has now admitted it breached regulatory codes, amounting to “bringing discredit upon, and reducing confidence in the pharmaceutical industry”, according to an interim case report from the ABPI. It also failed to maintain high standards and provide accurate and up-to-date prescribing information, the report said.
Theramex is a global pharmaceutical company specialising in women’s health products, such as hormone replacement therapy (HRT) and fertility treatments. Theramex UK is its London-based arm.
It supplies common HRT therapies including Evorel, Bijuve and Intrarosa. From April to June 2025, there were 760 000 prescriptions of Evorel and 2 748 prescriptions of Bijuve, according to data from the NHS Business Services Authority.
The complaint, filed in October 2024, alleged that some of Theramex’s products, like Intrarosa and Evorel, had not had their prescribing information updated. In the case of Evorel, information was “incomplete” and did not include information on common side effects such as uterine spasms and vaginal infection, the letter claimed.
For another drug, the letter alleged that prescribing information had not been updated for five years.
The complaint warned: “This oversight can lead to healthcare professionals (HCPs) not being fully informed of potential risks, which could jeopardise patient safety.”
The PMCPA panel found Theramix’s “failure to provide accurate and complete prescribing information was unacceptable”.
The employees also alleged the company failed to comply with regulators for clinical trial compliance warning. “The lack of resources within Theramex’s global headquarters to ensure compliance with these standards is alarming,” it said.
In response, Theramex UK said it took its obligations “very seriously” and had launched an internal investigation. It acknowledged that at the time of the complaint, it did not have a process in place for clinical studies.
The employees’ letter claimed it had tried to escalate matters to senior leaders within Theramex. The company claimed it was not aware of any of the matters having been escalated internally prior to them being reported to the regulator.
As part of the sanction, Theramex must provide written confirmation that it will cease practices that breach codes, pay a charge and advertise details of Theramex UK said it “absolutely acknowledges” the ruling and “respects the (regulator’s) decision”.