Policy responses and statements
Background: The MHRA wrote to the College inviting views on the reclassification from POM to P of Naproxen 250mg Tablets, which are indicated for primary dysmenorrhoea (period pain) in women aged between 15 and 50 years. Dysmennorrhoea or period pain is a common, chronic, recurring condition which afffects 40-70% of women of reproductive age. Naproxen has been licensed in the UK for over 30 years as a prescription medicine. Naproxen has also been available worldwide for a number of years. The commonest adverse reactions for NSAIDs including Naproxen are gastrointestinal reactions such as nausea, vomiting, diarrhoea, dyspepsia, abdominal pain and less frequently gastrointestinal ulceration and perforation. In addition, hypersensitivity reactions (including anaphylaxis, serious skin reactions and exacerbation of asthma), neurological reactions, bone marrow depression, nephrotoxicity, fluid retention and hepatic impairment may occur. The use of some NSAIDs may be associated with a small risk of arterial thrombotic events (for example, myocardial infarction or stroke). These serious adverse affects are usually associated with longer term, higher dose prescription use of naproxen in older patients. The nature of this application means that the use of naproxen will be limited to short periods of time at the lowest effective dose in otherwise health young females. This is emphasized in the product's labelling. Since the 1990's, Naproxen has also been available as a non-prescription medicine in Europe, the United States and Australia. A review of the Netherlands, German, Australian and American pharmacovigilance data did not detect any specific safety concern associated with non-prescription use. COMMENTS ON
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