Major HRT supplier sanctioned after whistleblowers raise concerns over patient safety
A group of employees from Theramex, which supplies HRT treatments to millions of patients in the UK, wrote a letter to the pharmaceutical regulator Association of the British Pharmaceutical Industry over allegations the company was not following regulatory standards and may 'jeopardise' patient safety.
The whistleblowers claimed some products featured inaccurate prescribing information and failed to highlight common side effects. They claimed they had been forced to contact the regulator after their attempts 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. In 2023-24, there were 2.8 million prescriptions of Evorel.
One employee wrote the complaint on behalf of a group, according to the complaint published by the Prescription Medicines Code of Practice Authority, which is part of the ABPI.
The complaint, filed in October 2024, said: 'We are a group of employees from various cross-functional teams at Theramex, and we are writing to express our growing concerns regarding the company's adherence to regulatory standards and the accountability of its leadership.
'While we have attempted to escalate these issues internally on numerous occasions, there has been a consistent lack of action or meaningful response, which leaves us with no choice but to seek external guidance and support.'
The complaint alleged that some of Theramex's products, such as Intrarosa and Evorel, had not had their prescribing information updated. In the case of Evorel, information for health professionals 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.
Finally, the letter alleged the company has a 'blame culture' that was 'deeply concerning.'
In response to the complaint, Theramex UK said it took its obligations under the ABPI code of practice 'very seriously' and launched an internal investigation.
It said that, although it had a process to update prescribing information, this was not sufficiently robust to ensure prescribing information was immediately updated.
The pharma company acknowledged it did not meet standards concerning this allegation and admitted 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 the case.
Theramex UK said it 'absolutely acknowledges' the recent ruling and 'respects the [regulator's] decision'. 'Of course, we remain fully committed to ensuring our practices align with the highest ethical standards and necessary steps and corrective measures have been taken,' it said.
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