HRT maker censured by UK regulator for ‘systemic failures’ that put patients at risk

One of the biggest producers of hormone replacement therapy has been censured by regulators for “systemic failures” that jeopardised patient safety.

Theramex, the UK producer of HRT drugs Evorel and Intrarosa, was found to have breached fundamental compliance standards including not updating crucial prescribing information – in some cases for several years – and not making it clear that a drug must not be used during pregnancy.

The Prescription Medicines Code of Practice Authority (PMCPA), the UK drug industry’s self-regulatory body, issued the public reprimand against Theramex after its own staff blew the whistle over “alarming” compliance issues and incomplete prescribing information for Evorel and Intrarosa that “jeopardise patient safety”.

Evorel patches – which contain estradiol – are among the most prescribed form of transdermal HRT, with more than 250,000 items issued in the last financial year, according to NHS Business Services Authority figures.

Overall, nearly 10m items of estradiol, including gels, were prescribed in the 2024/25 financial year.

The employees’ concerns included failing to provide comprehensive side-effect information in Evorel’s prescribing information, and not updating Intrarosa’s product information since 2019.

The PMCPA also reprimanded the company for failures to specify in its advertising at a reproduction and advertising conference that Yselty (linzagolix), used to treat uterine fibroids, should not be taken during pregnancy.

In all, PMCPA found that Theramex breached the Association of the British Pharmaceutical Industry (ABPI)’s code of practice 21 times.

The panel said these breaches not only jeopardised patient safety, but that Theramex has “brought discredit upon, and reduced confidence in, the pharmaceutical industry”.

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Source: The Guardian, 22 April 2026