Warning as common over-the-counter drug taken by millions globally
While the finding has only been demonstrated in animals, some experts say there's 'no need' for the drug
Katrina Turrill
A COMMON over-the counter medication that's been available for decades and is taken by millions worldwide has been singled out for its possible cancer risk.
Phenazopyridine, typically sold under brand names like Pyridium or Safrel and generally available over-the-counter in pharmacies and some supermarkets, is used to relieve symptoms caused by urinary tract infections.
Close-up of a woman taking a pill with water.
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Phenazopyridine has been linked to liver and bowel tumours in animal studiesCredit: Getty
It works by numbing the lining of the urinary tract, decreasing burning, irritation and discomfort.
But over the years, experts have warned the drug could cause cancer based on early evidence from animal studies.
After a study published in 2021, the National Institutes for Health (NIH) warned dietary exposure to phenazopyridine caused tumours in two rodent species in two different tissue sites.
Benign and malignant liver tumours were found in female mice, while benign and malignant bowel tumours were discovered in both sexes.
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It was noted while animal studies don't prove a direct link between human cancer and exposure to phenazopyridine, it is "reasonably anticipated to be a human carcinogen".
Phenazopyridine is available over the counter in the UK, but also by prescription in higher strengths.
Potential side effects include chest tightness, dizziness, headache, and loss of appetite, according to the Mayo Clinic.
More severe adverse reactions may include seizures, trouble breathing, and unusual bleeding or bruising.
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Rita Jew, president of the Institute for Safe Medication Practices, said personally she wouldn't advise taking phenazopyridine.
She told Bloomberg: "There is no need for this drug."
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In the UK, it's estimated that up to 1.7 million women experience chronic UTIs, and a significant number of men and children also suffer.
UTIs are usually caused by bacteria from poo entering the urinary tract.
The bacteria enters through the tube that carries pee out of the body, known as the urethra.
Women are more susceptible due to their shorter urethra, which gives bacteria a shorter path to the bladder.
Several factors can increase your risk of UTIs, including sexual activity, certain birth control methods, and pre-existing conditions.
Hygiene practices, age, and certain medical conditions also play a role.
Woman holding her crotch, experiencing discomfort.
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Phenazopyridine is used to relieve the pain, burning, and discomfort caused by infection or irritation of the urinary tract, but antibiotics is the most common treatmentCredit: Getty
The most common treatment for UTIs is a short course of antibiotics.
Remedies containing a mix of methenamine and sodium salicylate are seen as an alternative to phenazopyridine.
New York-based gynecologist Steven Goldstein, who recommends the medication to patients while they're awaiting the results of urine tests, said he was unaware of the cancer links.
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"It's the first time I'm even hearing about this. I'm totally unaware," he told Bloomberg.
The Sun has reached out to the Medicines and Healthcare products Regulatory Agency on phenazopyridine and its safety as a UTI medication.
Do you have a UTI and how should you treat it?
Symptoms of a urinary tract infection (UTI) may include:
pain or a burning sensation when peeing (dysuria)
needing to pee more often than usual
needing to pee more often than usual during the night (nocturia)
needing to pee suddenly or more urgently than usual
pee that looks cloudy
blood in your pee
lower tummy pain or pain in your back, just under the ribs
a high temperature, or feeling hot and shivery
a very low temperature below 36C
Your pee may also be dark or smell. If this is your only symptom, it might be because you've not been drinking enough water.Children with UTIs may also:
have a high temperature – your child is feeling hotter than usual if you touch their neck, back or tummy
appear generally unwell – babies and young children may be irritable and not feed or eat properly
wet the bed or wet themselves
be sick
If you or your child experiences any of these symptoms, see your GP.If a GP thinks you may have a urinary tract infection (UTI), they may do a urine test, although this is not always needed.A GP may also:
offer self-care advice and recommend taking a painkiller
give you a prescription for a short course of antibiotics
give you a prescription for antibiotics, but suggest you wait for 48 hours before taking them in case your symptoms go away on their own
It's important to take all the medicine you're prescribed, even if you start to feel better.If UTIs keep coming back, your GP may:
prescribe a different antibiotic or prescribe a low-dose antibiotic to take for up to 6 months
prescribe a vaginal cream, gel, tablet, pessary or ring containing oestrogen, if you are in perimenopause or have gone through the menopause
prescribe tablets that treat the infection and stop it from coming back
refer you to a specialist for further tests and treatments
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