MedicinesRegulator Gives Go-Ahead For First Ever Oral Antibiotic to Be Made Available Without Prescription to Treat Chlamydia
LONDON, Aug. 6, 2008-The Medicines and Healthcare products Regulatory Agency (MHRA) has today given approval for a medicine to be made available from a pharmacist without a doctor’s prescription to treat chlamydia. The azithromycin pill, which will be called “Clamelle”, will be available to buy by people 16 years and over if they have tested positive for the infection and have no symptoms, and for their sexual partners.
Dr June Raine, Director of Vigilance and Risk Management of Medicines at the MHRA said, “Chlamydia is the most common sexually transmitted disease in the UK. 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. 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.
“The MHRA is keen to support the availability of more medicines over-the-counter (OTC), where it is safe to do so, and we wish to move on to new areas such as prevention and chronic disease management. We know many pharmacists are ready for this too. Making this medicine available from a pharmacy is a real example of how we are progressing, and enabling people to play an active role in taking charge of their own healthcare.”
The medicine is expected to hit pharmacy shelves later this year.
Notes to Editor
1. Actavis UK Ltd is working in conjunction with the National Pharmacy Association (NPA) on training materials for pharmacists and launch plans for this medicine as well as a Clamelle-branded chlamydia test kit.
2. Azithromycin is a generic medicine. However, only this branded product will be made available OTC from a pharmacist.
3. An approved standard test is when a diagnosis of chlamydia is confirmed by a laboratory Nucleic Acid Amplification Technique (NAAT) test, a simple urine test which detects the nucleic acid of the C. trachomatis bacterium. A NAAT test is the required gold standard test for detecting chlamydial infection in men and women.
4. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone –the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action. www.mhra.gov.uk
Contact: Press Office 020 7084 3535/3564 or press.office@mhra.gsi.gov.uk
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