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Expert warning on OTC drug safety

By Lilian Anekwe

Drug safety experts have warned that patient safety risks being compromised by the drive to increase the availability of over the counter medicines.

Researchers have argued that the risks of increasing people's access to OTC medicines may outweigh the benefits, and are urging UK drug regulators to balance the decision to make a drug OTC ‘against the potential harm from unsupervised or inappropriate use.'

Hard-pressed GPs could benefit if drugs are made available OTC by having fewer consultations and writing fewer prescriptions for minor ailments. But Professor Robin Ferner, director of the West Midlands Centre for Adverse Drug Reactions, said there is ‘always residual uncertainty' about the safety of OTC medicines, and counts statins and antibiotics available without prescription as potential public health risks.

The call comes just a day after the MHRA announced that six cough remedies aimed at very young children are to be removed from shelves amid fears of accidental overdose.

The analysis, published today in the BMJ, concludes: The safety of over the counter medicines has to be continually reviewed [and] regulators should ask for clearer evidence of benefit at the over the counter dose if this is lower than the dose usually prescribed.

‘Given the concerns, it would be wise to avoid any wholesale rush to reclassify medicines', he added.

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