Theramex Censured by UK Regulator for Systemic Failures in HRT Drug Safety, Including Outdated Prescribing Information and Pregnancy Risk Omissions

One of the UK’s largest producers of hormone replacement therapy (HRT) has been publicly censured by the pharmaceutical industry’s self-regulatory body for systemic failures that jeopardised patient safety.

The Prescription Medicines Code of Practice Authority (PMCPA) issued a public reprimand against Theramex after identifying multiple breaches of fundamental compliance standards, including failure to update crucial prescribing information for several years and not making it clear that certain drugs must not be used during pregnancy.

The action followed whistleblowing by Theramex employees who raised concerns internally before being forced to contact the regulator when their attempts were ignored. Employees reported that products such as Evorel and Intrarosa featured inaccurate prescribing information and failed to highlight common side effects.

Evorel patches, which contain estradiol, are among the most prescribed forms of transdermal HRT in the UK, with more than 250,000 items issued in the last financial year according to NHS Business Services Authority figures. Nearly 10 million items of estradiol, including gels, were prescribed in the 2024/25 financial year.

The PMCPA found that Theramex had not updated Intrarosa’s product information since 2019 and failed to provide comprehensive side-effect information in Evorel’s prescribing details. The regulator stated that these failures brought discredit upon and reduced confidence in the pharmaceutical industry.

Theramex, a global pharmaceutical company specialising in women’s health products including HRT and fertility treatments, admitted to breaching regulatory codes. The company’s UK arm supplies common HRT therapies such as Evorel, Bijuve and Intrarosa to millions of patients.

From April to June 2025, there were 760,000 prescriptions of Evorel and 2,748 prescriptions of Bijuve according to NHS data, while in 2023-24 there were 2.8 million prescriptions of Evorel. The whistleblowers’ complaint, filed in October 2024, described their growing concerns about the company’s adherence to regulatory standards and leadership accountability.