UK's MHRA advice on immunosuppressant ciclosporin highlights risk of automatic substitution of generic drugs

A recent drug safety warning from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) on the dangers of switching immunosuppressants calls into question the safety of the Department of Health's proposal for Automatic Generic substitution.

Last December, commenting on the UK launch of Dexcel Pharma's Deximune (which contains ciclosporin), the MHRA said that the product has been show to be bioequivalent to Swiss drug major Novartis' Neoral. However, the Agency pointed out that the active ingredient is a 'critical dose' drug where small changes in bioavailability can compromise efficacy and risk loss of the graft, or may lead to drug toxicity, that could include renal impairment, hepatic dysfunction, hypertension and hyperlipidemia.

The Department of Health opened a full public consultation on January 5, 2010, on the arrangements for the implementation of Automatic Generic Substitution.

Timothy Statham, chief executive of the National Kidney Federation, said: 'Treating renal patients is extremely complicated - some take up to 24 medications per day. They have to take so many drugs that no substitution is safe; any changes to their treatment must be decided by the originating prescriber and no one else. We welcome the warning from the MHRA, and urge the Department of Health to exclude all renal patients if Automatic Generic Substitution is to go-ahead.'