August 5, 2008 / 11:05 PM / 11 years ago

Govt clears first oral antibiotic for OTC sale

LONDON (Reuters) - The government has given the green light for an oral antibiotic to be sold without prescription for the first time, in a move that pushes back the barriers to self-medication.

In this file photo a customer shops at a branch of Alliance Boots in central London April 20, 2007. The government has given the green light for an oral antibiotic to be sold without prescription for the first time, in a move that pushes back the barriers to self-medication. REUTERS/Toby Melville

Patients aged 16 years and over will be able to buy the azithromycin pill, sold as Clamelle by Icelandic drugmaker Actavis, to treat chlamydia, the Medicines and Healthcare products Regulatory Agency (MHRA) said on Wednesday.

It is designed for use by people who have tested positive for the sexually transmitted infection and have no symptoms. The drug will also be available on an over-the-counter (OTC) basis for their sexual partners.

Up to 70 percent of people who have chlamydia exhibit no symptoms but risk serious long-term health complications, including infertility and ectopic pregnancy.

“Today’s move means that symptom-free people diagnosed with chlamydia and their partner will be able to get convenient effective treatment from their local pharmacy,” said June Raine, MHRA director of vigilance and risk management of medicines.

The government has taken a lead in Europe in encouraging self-medication, as a way to increase patient choice and cut state healthcare bills.

The country already allows OTC sales of cholesterol-lowering and migraine drugs, as well as antibiotic eyedrops.

“The MHRA is keen to support the availability of more medicines over-the-counter, where it is safe to do so, and we wish to move on to new areas such as prevention and chronic disease management,” Raine said in a statement.

The increasing trend towards self-medication is expected to underpin future growth in the non-prescription medicines sector, which has seen a wave of consolidation.

Leading suppliers of OTC drugs include Johnson & Johnson, Reckitt Benckiser, Bayer, GlaxoSmithKline and Novartis.

Although azithromycin is a generic medicine, only Actavis’s branded product Clamelle will be made available OTC from pharmacists. Actavis, which was taken private last year, is working on launch plans for the medicine, as well as a Clamelle-branded chlamydia test kit.

Reporting by Ben Hirschler; Editing by David Holmes

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