A sildenafil 50mg product - Viagra Connect - could be available in the UK from spring 2018 without a prescription for men aged over 18 who have erectile dysfunction.
The MHRA announced its decision to reclassify the drug from a prescription-only medicine to one available over the counter this week, citing results of a public consultation, advice from the Commission on Human Medicines and a 'reassuring' safety assessment on the drug to support the move.
But GPC prescribing lead Dr Andrew Green told GPonline: 'There is no doubt that sildenafil is a safe and effective drug, but unfortunately the development of erectile dysfunction can be a warning sign of the presence of significant other disease. Diabetes, alcohol misuse and prostate cancer may all present with difficulties sustaining an erection, and erectile dysfunction in itself is a risk factor for cardiovascular disease.
Erectile dysfunction
'I would therefore expect patients who see GPs with this problem to have investigations to exclude these conditions. I do have some concerns that these regulatory changes may mean that an opportunity to diagnose patients with significant disease, or to address the lifestyle factors that may be contributing to their problems, may be missed.'
An MHRA statement said the medicine 'will be sold from pharmacies following a discussion with the pharmacist'. It adds: 'Pharmacists will be able to determine whether treatment is appropriate for the patient and can give advice on erectile dysfunction, usage of the medicine, potential side effects, and if further consultation with a general practitioner is required.
'Viagra Connect will not be sold to those with severe cardiovascular disorders, at high cardiovascular risk, liver failure, severe kidney failure, or taking certain interacting medicines. Use of Viagra Connect in these groups of men must continue to be under the supervision of a doctor.'
Counterfeit medicines
The MHRA says that the decision to make the drug available over the counter could 'help direct men who might not otherwise seek help into the healthcare system and away from the risks that come with buying medicines from websites operating illegally'.
Dr Berkeley Phillips, UK medical director for Pfizer - which makes Viagra - said: 'The availability of Viagra Connect in pharmacies from next year will offer men who are eligible for the product a new and convenient way to access sildenafil, a commonly prescribed treatment for erectile dysfunction.
'We understand some men may avoid seeking support and treatment for this condition, so we believe giving them the option to talk to a pharmacist and buy Viagra Connect could be a real step forward in encouraging more men into the healthcare system. As erectile dysfunction may be a sign of an underlying condition such as diabetes, high blood pressure, or heart disease, there could also be a wider benefit to public health in the long term.'
