OTC antibiotic switch halted 'after Government opposition'
By Lilian Anekwe
Exclusive: The controversial switch of the antibiotic trimethoprim to over the counter status has been halted, after the manufacturer withdrew its application following concerns over a rise in antibiotic resistance to the treatment.
According to experts, the Government has stepped in to halt the change in a massive blow to the Medicines and Healthcare products Regulatory Agency's (MHRA) drive to make more treatments for self-limiting conditions available over the counter.
Pulse has learnt Actavis and Goldshields, the manufacturers of Cysticlear and Cystobid, have withdrawn their applications for OTC status following staunch opposition from the highest level within the Department of Health.
Pulse first revealed in August 2008 that the MHRA intended to recommend to the Commission for Human Medicines that the licensing for the antibiotic trimethoprim should be changed from a prescription only medicine to one available at pharmacies, along with nitrofurantoin, for the treatment of uncomplicated urinary tract infections in women.
The MHRA had sought to phase-in the introduction of trimethoprim availability through pharmacies, but the plans drew a furious response from the MHRA's own advisors, who criticised the agency for making decision that were ‘determined commercially and not on the basis of medical need'.
GPs and infectious disease experts were also outraged, including the British Society for Antimicrobial Chemotherapy (BSAC).
Senior members of the BSAC committee, who counted several Government advisors amongst their ranks, wrote a fiercely-worded letter to former health secretary Alan Johnson and the health ministers in the other three UK countries, warning them the MHRA were poised to make a ‘potentially disastrous' decision.
Professor Peter Davey, professor of infectious disease and vice president of the BSAC, told Pulse he was ‘delighted' by the climbdown.
‘We are hoping that this will be the end of it but we are already worried that it won't be. They need to say that this whole process of making more drugs available over the counter should not be applied to antibacterials. Otherwise there's still the opportunity for people to appeal in the future.
‘The Department of Health was unusually explicit about their opposition to the reclassification, and really forthright about the Chief Medical Officer being dead against it. He felt it went completely against what the European Parliament said: that no country should be issuing OTC reclassifications for systemic antibiotics.'OTC antibiotic switch halted after concerns over antibiotic resistance