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Viagra to become over-the-counter medicine, MHRA rules

Viagra (sildenafil) will become available in pharmacies without a prescription, the Medicines and Healthcare Products Regulatory Agency (MHRA) has announced.

Previously classified as a prescription-only medicine (POM), sildenafil is now a pharmacy medicine (P), available to men over 18 who have erectile dysfunction (ED).

The decision came after the Commission on Human Medicines conducted an assessment of the product’s safety and a public consultation in March.

The MHRA’s report said that the drug ‘does not present a direct or indirect danger to human health if used, even correctly, without the supervision of a doctor'.

It said: ‘Overall, there are no identified concerns related to how it works, interactions with other medicines and side effects that are not already well documented.’

However, pharmacists will only be able to sell the product once they have determined whether treatment is appropriate for the patient.

It won’t be made available to men suffering severe cardiovascular disorders, such as liver failure and severe kidney failure, or at high cardiovascular risk.

When MHRA's consultation was launched earlier this year, the BMA's GP Committee had warned that could the move to make it a pharmacy medicine could end up denying men proper assessment and treatment for ED.

And the GPC’s prescribing policy lead Dr Andrew Green warned the move not only posed safety concerns but could also prove to be ‘a Trojan horse’ for pushing through restrictions on its availabilityon the NHS.

ED is a very common condition affecting one in 10 men in the world, with more than 20 million who have used or are using Viagra.

But counterfeited medicines treating ED are popular. Since 2012, investigators from the MHRA have seized more than £350m worth of unlicensed and counterfeit ED drugs.

Mick Foy, the MHRA’s group manager in vigilance and risk management of medicines, said: ‘This decision is good news for men’s health. The move to make Viagra Connect more widely accessible will encourage men to seek help within the healthcare system and increase awareness of erectile dysfunction.’

He added: ‘Erectile dysfunction can be a debilitating condition, so it’s important men feel they have fast access to quality and legitimate care, and do not feel they need to turn to counterfeit online supplies which could have potentially serious side effects.

 

Readers' comments (4)

  • Ten years late. But better late than never.

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  • Great idea. 50 mg Sildenafil enough to work in many cases. Generally a very safe medicine. Should be taken on an empty stomach with water. Allow 40-80 minutes to work. Men work better in the morning as testosterone levels rise. Does require sexual stimulation. Best way to work- use it in the morning.

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  • Safe medication - yes - but shame we'll miss out on cases where it's a first presentation of undiagnosed peripheral vascular disease, diabetes, etc. They say they won't give to those with high CVRA risk - this depends on this having been calculated, requiring info from primary care. Erectile Dysfunction also increasing in incidence in younger men due to psychosocial issues, unrealistic expectations etc which need a whole different type of management - framing ED as a simple condition with one unifying panacea of a small blue pill seems narrow-minded.
    My view is that first assessment - doctor - subsequent prescribing etc - pharmacist.

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  • What you say is correct, but you underestimate our pharmacy friends. Sudden onset especially in a young person usually means psychological. They can easily decline prescribing sildenafil until after investigated. Giving 1 packet of 4 x 50mg sildenafil is unlikely to do too mach harm. I used to always recommend fasting lipids & glucose check and anyone over 50 a PSA. It is far better for a qualified pharmacist to prescribe than someone to buy on the internet a totally unknown product with little or no guidance.

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