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Naproxen painkillers available OTC

The Medicines and Healthcare products Regulatory Agency (MHRA) announced on April 1 that naproxen painkillers have been approved as over-the-counter (OTC) medicines.
The Medicines and Healthcare products Regulatory Agency (MHRA) announced on April 1 that naproxen painkillers have been approved as over-the-counter (OTC) medicines.

Naproxen tablets, which have been used for the treatment of rheumatic diseases and other musculoskeletal illnesses in the UK for over 30 years, are to be offered for sale as a painkiller for period pain (primary dysmenorrhoea). Manufactured by Bayer Healthcare, naproxen tablets are known by the brand name of Feminax Ultra.

Period pains affect an estimated 40 to 70 per cent of women of reproductive age and can interfere with the daily routine of 10 per cent of females. Hitherto the only painkillers women could buy for primary dysmenorrhoea were ibuprofen tablets.

Dr Julie Raine, director of vigilance and risk management of medicines at the MHRA, said: "Period pain is a condition which can be successfully managed by women themselves. OTC naproxen will expand the choice of treatments available for this common condition from pharmacies."

The Commission on Human Medicines (CHM) determined that the benefits of women taking Feminax Ultra to relieve period pains outweighed the risks presented by offering it as an OTC medication.

The MHRA said: "This approval ties in with a wider MHRA initiative of widening availability of medicines for women's health."

The Royal Pharmaceutical Society of Great Britain (RPSGB) has given its support behind pharmacists to dispense OTC medicines despite concerns raised in an article by the British Medical Journal.

Sadia Khan, the RPSGB's lead pharmacist for self care, said: "The society welcomes the reclassification of naproxen 250mg tablets and believes that this switch will provide women with more choice, convenience and better access to medicines for relief from period pain. It also enables pharmacists to use their skills and expertise in medicines."

2nd April 2008

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