Medicines Regulator Approves A New Over-the-counter Medicine For The Treatment Of Period Pain, UK

Main Category: Pain / Anesthetics
Also Included In: Women's Health / Gynecology;  Regulatory Affairs / Drug Approvals
Article Date: 02 Apr 2008 - 1:00 PDT

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The Medicines and Healthcare products Regulatory Agency (MHRA) announces approval of naproxen 250mg tablets to be made available from pharmacies under the brand name Feminax Ultra for the treatment of period pain (primary dysmenorrhoea) for women aged between 15 and 50 years. Medicines containing naproxen are currently available on prescription only.

It is estimated that 40-70% of women of reproductive age experience period pain during their menstrual cycles. For up to 10% of women period pain can interfere with their daily activities.

Over-the-counter (OTC) naproxen provides an alternative to ibuprofen, which is the only non-steroidal anti-inflammatory drug (NSAID) currently available OTC for the treatment of primary dysmenorrhoea.

The Commission on Human Medicines (CHM) carefully considered the safety issues before recommending approval and concluded that in these women the benefits outweigh the risks. Pharmacists may check age and symptoms with the individual to make sure it is safe to supply this medicine.

Dr June 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."

This approval ties in with a wider MHRA initiative of widening availability of medicines for Women's Health.

Notes

1. Naproxen is a non-steroidal anti-inflammatory drug (NSAID). It inhibits the synthesis of prostaglandins, which are thought to be responsible for the development of period pain. Clinical guidelines recommend OTC analgesics including NSAIDs for the treatment of primary dysmenorrhoea.

2. Naproxen has been licensed in the UK for over 30 years as a prescription medicine for the treatment of rheumatic disease and other musculoskeletal disorders, dysmenorrhoea, and acute gout. Based on data from the Prescription Pricing Division in England approximately 1 million naproxen prescriptions are issued every year for all licensed indications.

3. Details of the consultation for naproxen 250mg tablets are published on our web site http://www.mhra.gov.uk

4. A seminar in 2007, hosted by the MHRA, involved key stakeholders from professional bodies, the pharmaceutical industry and government to discuss the access and choice of medicines for Women's Health. The discussions also centred on the question how to move medicines from prescription only status (POM) to pharmacy availability (P).

5. The MHRA supports the reclassification of medicines to widen their availability where it is safe to do so. A consultation exercise on the switch of the antibiotic nitrofurantoin (Cystobid) from prescription only to pharmacy availability for the treatment of acute urinary tract infection in women began on 8 March and will end on 14 April 2008.

6. 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.

Medicines and Healthcare products Regulatory Agency