UK's MHRA consults on P status naproxen

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced a consultation on whether naproxen 250mg tablets, should be made available from pharmacies for the treatment of period pain (primary dysmenorrhea) for women aged between 15 and 50 years. In the UK 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. In up to 10% of women, this can interfere with daily activities, notes the MHRA. If naproxen becomes available over-the-counter, it would be an alternative to ibuprofen, which is the only non-steroidal anti-inflammatory drug currently available OTC for the treatment of primary dysmenorrhea. This proposal is in line with a larger MHRA initiative of widening the availability of medicines for women's health.

June Raine, Director of Vigilance and Risk Management of Medicines at the MHRA, commented: "period pain is a condition which can be successfully managed by women themselves. OTC naproxen would expand the choice of treatments available for this common condition from pharmacies."