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

Drug industry’s self-regulatory body criticises Theramex, producer of Evorel and Intrarosa, for ‘alarming’ breaches

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.