UK’s MHRA cracks down on substitution of some epilepsy drugs

In what is seen as an exception to conventional international rulings, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has issued new guidance to prescribers, pharmacists and patients in relation to anti-epileptic drugs (AEDs).

This follows a review by the Commission on Human Medicines (CHM) which looked at the evidence on patients switching between different manufacturers’ products of particular AEDs. The CHM concluded that, while there was no clear evidence of harm associated with switching products, an effect in some patients, for some drugs, could not be completely ruled out.

The potential effects of switching may include a loss of seizure control or the occurrence of side effects, or both. These risks can be associated with switching between a branded originator and a generic product, and between different generic products.