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The Government's over-the-counter drive has been thrown into confusion after its drug watchdog appeared to rule out two new applications over 'safety concerns' ­ but then performed a dramatic U-turn.

Published minutes originally revealed the Committee on Safety of Medicines had rejected applications for an ophthalmic antibiotic and a drug for primary dysmenorrhoea to switch to OTC.

The products are among the first to seek a switch to OTC since the Government published its wish-list of products, including chloramphenicol and dysmenorrhoea drug mefenamic acid in 2002.

After being approached by Pulse to explain the rejection, the Department of Health first stalled and then said there had been a 'drafting error' and that no decision had been made. It withdrew the minutes and said it would post a revised version (see box).

A source within the committee told Pulse members had been 'anxious' about making antibiotics available OTC. The department admitted the original minutes had been signed off by all members

of the committee but claimed no one had spotted the error.

Last week experts warned a loosening of restrictions on antibiotics could cause a surge in microbial resistance after Pulse learned Aventis Pharma had applied for OTC status for chloramphenicol eyedrops.

Dr Peter Fellows, GPC prescribing sub-committee chair, said antibiotics were 'a particular cause for concern' in the sale of drugs OTC because of fears over resistance.

But Dr John Blenkinsopp, an adviser to the pharmaceutical industry on 13 OTC applications, said the moves had the 'highest level of authorisation'.

Other than chloramphenicol there are three ophthalmic antibiotics on the OTC wish-list, although the manufacturer of one of these said it had not filed an application.

The department was unable to provide a CSM spokesperson or explain how the error was made.

The committee assessed a request for a change of legal status from 'prescription' to 'pharmacy' for drugs to be used in the treatment of primary dysmenorrhoea....and an ophthalmic antibiotic. In both cases the committee agreed that these changes cannot be recommended because of safety concerns.

Minutes of CSM's September 30 meeting until withdrawn on November 10

The committee is still considering the applications for reclassification of these drugs.

Department of Health press office, November 11

By Cato Pedder

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