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HRT Giant Theramex Censured for Patient Safety Failures
22 Apr
Summary
- Theramex failed to update critical HRT drug prescribing information for years.
- Employees reported alarming compliance issues and incomplete patient safety data.
- The company breached the pharmaceutical code of practice 21 times.
The UK drug industry's self-regulatory body has publicly reprimanded Theramex, a significant producer of hormone replacement therapy (HRT) drugs, for systemic failures that endangered patient safety. The Prescription Medicines Code of Practice Authority (PMCPA) cited "alarming" compliance issues discovered by whistleblowing employees.
Theramex, responsible for HRT medications Evorel and Intrarosa, failed to update vital prescribing information, in some instances for several years. Critical omissions included not clearly specifying that a drug must not be used during pregnancy, and inadequate side-effect information for Evorel.
Furthermore, the company was reprimanded for not clarifying that Yselty, used for uterine fibroids, should not be taken during pregnancy, as specified in its advertising. In total, Theramex breached the Association of the British Pharmaceutical Industry's (ABPI) code of practice 21 times.
These breaches not only jeopardized patient safety but also "brought discredit upon, and reduced confidence in, the pharmaceutical industry," according to the PMCPA. Theramex's decision to leave the PMCPA's jurisdiction was also condemned, as it delayed regulatory action by necessitating MHRA involvement.
Theramex stated it has addressed these historical matters promptly and conducted a comprehensive review of its compliance framework. The company withdrew from PMCPA's jurisdiction in January 2026, opting for direct regulation by the MHRA to focus resources on maintaining high ethical and compliant behavior.
