Medicines and Healthcare products Regulatory Agency (MHRA)

Safety review launched into anti-epileptic medicine topiramate over fears of harm to unborn children

The review was prompted by study results that showed there was a two- to four-fold increased risk of developmental disorders or learning difficulties in children exposed to topiramate before birth.…

MHRA to consider evidence on transgenerational effects of sodium valproate

The regulator has asked the Commission on Human Medicines to look at data showing the transgenerational effects of sodium valproate in mice.…

First monoclonal antibody treatment approved for prevention of COVID-19

Evusheld is the first monoclonal antibody treatment to be approved as a 'pre-exposure prophylaxis' treatment.…

More than 15,000 falsified medicines found in UK supply chain over past two years

Exclusive: The Medicines and Healthcare products Regulatory Agency has identified 15,000 falsified medicine packs since the UK left the European Union in January 2020.…

Dual action ibuprofen and paracetamol tablets should not be moved to general sale, RPS says

In its response to a public consultation, the Royal Pharmaceutical Society says moving painkiller Nuromol to the general sales list may lead to patients confusing it with paracetamol and taking a higher dose than instructed.…

Some antiepileptic drugs are safer than others for use during pregnancy, MHRA review concludes

Two antiepileptic drugs, lamotrigine and levetiracetam, are safer to take in pregnancy than others, a safety review by the Medicines and Healthcare products Regulatory Agency has found.…

Hayfever medicine made available over the counter

The allergy and hayfever medicine Allevia (fexofenadine hydrochloride) 120mg tablets have been moved from a prescription-only medicine to the General Sales List.…

Narcolepsy medicine linked to increased risk of birth defects, warns medicines regulator

Narcolepsy medicine modafinil should not be taken during pregnancy owing to an increased risk of congenital malformations.…

Falsified Medicines Directive will close in Great Britain at the end of 2020

Pharmacies in Great Britain should ensure that their systems are no longer connected to the UK Medicines Verification System at the end of 2020, the UK FMD Working Group for Community Pharmacy has said.…

Valproate for treatment of bipolar disorder to be ‘reconsidered’ by MHRA

The use of valproate in the treatment of bipolar disorder in women who can have children is to be “reconsidered” by the Medicines and Healthcare products Regulatory Agency.…