Popular erection pills such as Viagra and Cialis have been linked to more than 200 deaths in Britain, MailOnline can reveal.
None of the fatalities — all of which have occurred since 1998 — are proven to have been caused directly by the drugs.
But the UK’s drugs watchdog is aware of the link.
However, experts insist the pills are safe and many incidents could actually reflect deaths linked to sex in men with heart issues instead.
Men can buy sildenafil, Viagra’s main ingredient, and other impotence pills over the counter for as little as £15 and tablets available online for as little as £1.30 per pill.
Any reported suspected side effects are logged under the Medicines and Healthcare products Regulatory Agency (MHRA) ‘Yellow Card’ scheme.
Officials use the same database, set-up in the wake of the 60s thalidomide scandal, to track the safety of Covid vaccines.
Although impossible to prove, it allows doctors, pharmacists and patients to report adverse reactions believed to be caused by drugs used in Britain.
This can lead to them being reviewed, having warnings added to the labels or being taken off the market completely.
MailOnline found 2,441 reports for sildenafil, tadalafil (branded as Cialis), vardenafil (Levitra) and avanafil (Spedra) in the MHRA database.
Of these, 1,600 were for serious reactions, but only sildenafil and tadalafil recorded any fatalities (205, in total).
Most of the reported deaths were linked to incidents involving the heart or the brain
Forty-five deaths were reported in women, even though they don’t gain the same sexual arousal benefits as men when taking the drugs.
Such medications also, less famously, treat pulmonary hypertension, a type of high blood pressure in the arteries that supply the lungs.
The same mechanism by which the drugs increase blood flow to the penis also relaxes blood vessels in the chest to treat pulmonary hypertension, hence why some women and children might take it.
Overall, people in their 60s accounted for the highest number of reported fatalities (66), nearly a third of the total.
For deaths with a stated cause, the majority related to disorders of the arteries that supply the heart, with 50 such deaths.
Most of these (31) were specifically linked to heart attacks.
Another large category for reported deaths was nervous system disorders, with 18 fatalities.
The majority of these related to cerebral haemorrhages — bleeds caused by blood vessels rupturing in the brain which can trigger strokes, a known rare potential side effect of the drugs.
Mental health issues were also reported in relation to the medications, including five cases of suicide.
Other less serious adverse reactions were also reported.
A total of 57 Brits reported suffering diarrhoea after taking the medications. Another eight reported an unusual level of flatulence.
Sildenafil, Viagra’s main ingredient, is used to treat both impotency as well pulmonary hypertension. Pictured here is the Viagra branded version
Cialis, the active ingredient of which is the drug tadalafil is another popular erectile dysfunction medication in the UK
Four reported hallucinations, with one experiencing an unusual state of euphoria.
Some (37) ironically reported having increased, spontaneous or painful erections as an unwanted side effect.
These are, most likely, people taking the medications for non-impotency related reasons and to whom the drugs’ other purpose may have come as a surprise.
However, some Brits found the opposite effect, with over a dozen reports that taking the pills decreased in their libido or ability to get erections.
Millions of British men now take drugs to help impotency.
The latest NHS backed data shows 22million prescriptions for these drugs were handed out by GPs in England between 2019 and 2023, at the cost of £91million.
This data doesn’t cover over the counter purchases, with many high street pharmacies, as well as online shops, now selling their own brand versions.
The drugs are already known by medics to be dangerous in some circumstances. For example, Brits with known heart problems are advised to avoid taking them.
Even leaflets handed out with sildenafil acknowledge cases of sudden death in men having taken the drug though it insists such cases are rare and mostly in men with heart problems.
‘It is not possible to determine whether these events were directly related to sildenafil,’ it also adds.
However, with many Brits unaware of the ‘Yellow Card’ system other side effects linked to impotency drugs may have been missed.
Professor Amr Raheem, a consultant andrologist at men’s health business Adam Health, said it was critical to remember the context in which people used impotency drugs when looking at the MHRA data.
‘It’s imperative to understand that sexual activity, akin to any form of physical exertion, carries a risk of cardiac events, especially in individuals with pre-existing cardiovascular conditions,’ he said.
‘The main issue, therefore, is the potential for cardiac events during the physical activity involved in sexual intercourse, rather than the direct effect of the ED (erectile dysfunction) medication.’
He added that while no drug was 100 per cent safe, medications like sildenafil and tadalafil have a very good track record.
‘Millions of men have benefitted from these drugs, which have been subject to extensive testing and research, affirming their safety and efficacy,’ he said.
But Professor Raheem added that, given the nuances in how these medications can interact with other conditions, supervision from a qualified health professional before taking the medication was critical.
Millions of British men now take drugs to help impotency. The latest NHS backed data shows 22million such prescriptions for these drugs were handed out by GPs in England between 2019 and 2023 to the cost of £91million (stock image)
‘This is especially pertinent now that Viagra and Cialis can be obtained without a prescription in the UK,’ he said.
An MHRA spokesperson said: ‘Sildenafil and tadalafil have been used for many years to treat erectile dysfunction without any serious safety concerns.
‘The side effects known to be associated with their use are listed in the information provided to healthcare professionals and patients.
‘This information also contains guidance on which patients cannot safely take these medicines and which other medicines and medical conditions increase the likelihood of experiencing side effects.’
The spokesperson added they continually review the safety of all medicines, including sildenafil and tadalafil, including Yellow Card reports.
They added: ‘The nature of Yellow Card reporting means that reported events are not always proven side effects and some events may have happened anyway.’
Every drug has to go through safety trials before being made available to the public.
But there is an unavoidable risk that rare reactions or interactions with other illnesses and conditions may have been missed.
Systems like MHRA’s Yellow Card reports allow experts to track potential side effects through active monitoring, though some MPs are concerned the system isn’t proactive enough.
Such reports cannot prove the product in question is to blame.
For example, a heart attack recorded in a patient taking an impotency drug may simply be a coincidence, and nothing to do with the medication.
Adverse reactions linked to impotency drugs have been reported before in medical literature.
MailOnline reported last month how a Brazilian man suffered a never-before-seen reaction which saw him break out in pustules across his body after taking tadalafil, sold as Cialis in the UK.
Other reports have linked taking sildenafil to eye problems, including vision loss.
No medication is risk free and erectile dysfunction pills are no exception.
The NHS says about one in 100 people will experience common side effects from taking sildenafil, the UK’s most prescribed erectile dysfunction drug.
These include headaches, nausea, hot flushes, indigestion, a stuffy nose and dizziness, according to the NHS.
The health service warns that people taking the pills for longer periods, such as for pulmonary hypertension, are more likely to experience these than those taking the pills for erectile dysfunction.
More serious side effects requiring urgent medical care are estimated to affect less than one in 1,000 people.
These include seizures, suffering a prolonged and potentially painful erection especially for over two hours, chest pain, and in very rare cases a life threatening allergic reaction to the medication called anaphylaxis.
