Popular over-the-counter drugs used to treat uncomfortable urinary tract infections may come with a potential cancer risk.
The drug is called phenazopyridine hydrochloride and is found in many pills - both generic and name-brand - that are used to treat a urinary tract infection. Women are typically at a higher risk than men for those kinds of infections. The pill, many of which sell for less than $15, are used to help reduce pain, burning and irritation associated with the infections. They promise relief in as little as 20 minutes.
Phenazopyridine hydrochloride has been used for decades and is not approved by the U.S. Food and Drug Administration. Now, recent studies have raised questions about its use.
“There is no need for this drug,” Rita Jew, who serves as the president of the Institute for Safe Medication Practices, told Bloomberg.
“The data available from epidemiological studies are inadequate to evaluate the relationship between human cancer and exposure specifically to phenazopyridine hydrochloride,” the report said.
There are more than 8 million related visits to healthcare providers in the U.S. each year to treat a UTI, according to the American Urological Association. Many people experience repeat infections, and around 60 percent of women and 12 percent of men will have at least one UTI during their lifetimes.
But, even the labels on the drugs recognize that there is risk associated with the products.
“This product contains Phenazopyridine hydrochloride, known to the State of California to cause cancer,” the AZO label says.
“Long-term administration of phenazopyridine HCl has induced neoplasia in rats (large intestine) and mice (liver). Although no association between phenazopyridine HCl and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted,” the URISTAT Pain Relief Tablet box notes. Neoplasia is the abnormal growth of cells.
It was also listed by the New Jersey Department of Health and Senior Service as a hazardous substance in 2001.
Bloomberg also flagged that Phenazopyridine hydrochloride has been blamed for masking serious infections, slowing breathing, upset stomach and reddish-orange urine One adverse effect, known as methaemoglobinaemia, is rare but can be life-threatening.
Still, even physicians may not have heard about the ties to cancer.
“It's the first time I'm even hearing about this. I'm totally unaware,” New York-based gynecologist Steven Goldstein told Bloomberg.
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