This site is intended for health professionals only


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.