Consultation on POM to P naproxen switch launched
Women with period pain could soon be able to purchase naproxen over
the counter |
The number of medicines that women can buy over the counter to treat period pain may soon increase with the launch last week of a consultation on naproxen's switch from POM to P status.
The Medicines and Healthcare products Regulatory Agency is consulting on
whether naproxen should be made available from pharmacies for the treatment
of primary dysmenorrhoea for women aged between 15 and 50 years.
It is estimated that 40 to 70 per cent of women of reproductive age suffer
from dysmenorrhoea and in 10 per cent of cases it can interfere with
daily life.
Ibuprofen is currently the only non-prescription non-steroidal anti-inflammatory
drug that is licensed to treat dysmenorrhoea. Naproxen has been licensed
as a prescription-only medicine in the UK for over 30 years; it has been
available as a non-prescription medicine in Europe, the US and Australia
since the 1990s.
Galpharm International is proposing that naproxen tablets 250mg are made
available in a maximum pack size of nine tablets (three days’ supply
at a maximum daily dose of 750mg). In terms of its gastrointestinal safety,
Galpharm says that ulcer disease is infrequent in women less than 50
years old, and that this, along with limiting the pack size and emphasising
that women should titrate to the lowest effective dose, should result
in a low risk of gastrointestinal adverse events.
A consultation on the POM
to P switch of tranexamic acid for the treatment
of heavy menstrual bleeding is currently under way (PJ, 10 February,
p153). These proposed switches tie in with a wider MHRA initiative of
increasing availability of medicines for women’s health.
Comments should be sent to Veronica Popo, Room 14–138, Market Towers,
1 Nine Elms Lane, London SW8 5NQ (e-mail veronica.popo@mhra.gsi.gov.uk)
by 23 May. The consultation
document is available on the MHRA website.
|
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