MHRA approves first OTC antibiotic in UK, Actavis’ Clamelle

by | 6th Aug 2008 | News

The body responsible for drug regulation in the UK has given the green light to the first ever oral antibiotic to be sold without a prescription in the country.

The body responsible for drug regulation in the UK has given the green light to the first ever oral antibiotic to be sold without a prescription in the country.

The Medicines and Healthcare products Regulatory Agency has given approval for Actavis’ chlamydia drug Clamelle (azithromycin) to be sold over-the-counter in the UK later this year. Actavis applied to switch azithromycin from prescription-only to pharmacy status and its version will soon be available to people aged 16 and older who have tested positive for the infection and have no symptoms. Their sexual partners will also be able to receive OTC Chamelle.

The move has been opposed in certain quarters amid fears that by-passing the doctor in such cases sets a dangerous precedent. However, the increase in the cases of chlamydia infection in the UK, where it is the most common sexually transmitted disease, has led the agency to explore other options to give people easier access to treatments.

June Raine, the MHRA’s director of vigilance and risk management of medicines, stated that up to 70% of people who have chlamydia have no symptoms and could therefore remain undiagnosed. “This means that they are at huge risk of serious long-term health complications, including infertility and ectopic pregnancy”, she said, so the move means that symptom–free people diagnosed with chlamydia and their partner will be able to get “convenient effective treatment from their local pharmacy”.

Ms Raine went on to say that the MHRA “is keen to support the availability of more medicines OTC, where it is safe to do so”. She added that “we wish to move on to new areas such as prevention and chronic disease management. We know many pharmacists are ready for this too”.

The move got the approval of the Royal Pharmaceutical Society of Great Britain. Howard Duff, RPSGB’s Director for England, said that pharmacists already play an important role in the provision of sexual health services, “and have done so for many years. Reclassifying azithromycin will expand on existing services and improve access to chlamydia screening and treatment”.

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