MHRA: sildenafil reclassified from POM to P

  • International Medical Press
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The UK Medicines and Health Regulatory Agency (MHRA) has reclassified the erectile dysfunction medication sildenafil, making it available over-the-counter.

Following a public consultation, sildenafil 50 mg – which until now was a prescription-only medicine – can be sold to men over the age of 18 with erectile dysfunction under the clinical judgement of a pharmacist.

Experts said improving accessibility to the drug may help men who do not feel comfortable speaking about impotence to their GP, and may also prevent people from buying unlicensed and counterfeit versions of the medication. Over the last 5 years, the MHRA has seized counterfeit erectile dysfunction medicines worth more than £50 million.

In order to ensure safe sales of sildenafil, pharmacists will offer full counselling to patients, including information on the condition, appropriate use of the medication, side-effects and whether GP referral is required.

The MHRA has outlined that sildenafil will not be sold to people with:

  • severe cardiovascular disorders
  • high cardiovascular risk
  • liver failure
  • severe kidney failure
  • medicines which interact with sildenafil.

Dr David Edwards, GP and Former President of the British Society of Sexual Medicine, said the condition can leave many men with a ‘sense of isolation’.

‘A new initiative that enables men to go to a pharmacy to get help for their erectile dysfunction is welcome,’ he said.

Similarly, Mick Foy, Group Manager in Vigilance and Risk Management of Medicines at MHRA, explained that the decision was ‘good news for men’s health’. He said that making sildenafil more widely accessible ‘will encourage men to seek help within the healthcare system and increase awareness of erectile dysfunction’.

However, of the 47 responses received at MHRA’s consultation, 8 pharmacists highlighted that they did not support the reclassification. Many were concerned that patients may withhold key medical information from them in order to obtain the drug, and also that wider accessibility may increase the risk of it being abused.  

Sildenafil 50 mg is planned to be in UK pharmacies with its new classification status by spring 2018.