25-05-2025
Popular Over-the-Counter Drug Phenazopyridine Linked to Possible Cancer
Over-the-counter medicine may seem harmless because a prescription from a doctor isn't needed to get it. But over-the-counter drugs are still medicine, and it's always important to check with a doctor before taking any meds.
"Over-the-counter medicine is also known as OTC or nonprescription medicine," the Food and Drug Administration states on the agency's website. "All these terms refer to medicine that you can buy without a prescription. They are safe and effective when you follow the directions on the label and as directed by your health care professional."
Now, a drug that has been available for decades is being singled out as having a possible link to cancer and other health issues.
According to a May 19 report in Bloomberg, phenazopyridine is a drug used to control pain from urinary tract infections. "Sold under such brand names as Azo and Uristat, it's available in most U.S. pharmacies or groceries with a well-stocked health aisle and doesn't require a prescription," Anna Edney of Bloomberg states in the piece.
"Phenazopyridine is used to relieve the pain, burning, and discomfort caused by infection or irritation of the urinary tract," the Mayo Clinic says of the medicine.
According to Bloomberg, "Phenazopyridine belongs to a vast pool of widely available drugs for which the FDA has never adopted formal rules." Edney adds that these medicines are "grandfathered in." The medicine is also not available in Canada or major European countries without a prescription, according to the report.
So, what's the issue with the drug? Bloomberg states that it "has been faulted for masking serious infections that require medical attention and antibiotics," and "in high enough doses or if taken too long, it can slow breathing and lead to death, according to multiple physician accounts in medical journals and adverse event reports filed to the FDA."
The report adds that "phenazopyridine may also cause cancer" and that "a National Cancer Institute study in 1978 showed it caused tumors in lab rats and mice, and the National Toxicology Program describes it as 'reasonably anticipated to be a human carcinogen.'"