| When you walk into a pharmacy or retailer with a health and wellness aisle, it would make sense that you’d assume any drug you pick up would have been thoroughly vetted by the Food and Drug Administration. But this isn’t always the case. And for a nonprescription drug called Azo that falls into this grandfathered category, the potential dangers are many. Azo is meant to help treat pain associated with urinary tract infections. The small reddish brown pills are sold by a Dutch company called DSM-Firmenich, and stores like Walmart and Target sell their own generic versions that go by the active ingredient, phenazopyridine. None of these versions of Azo have been approved by the FDA. The agency, which is chronically underfunded and understaffed particularly when it comes to nonprescription drugs, hasn't completed work on many older medications that it started in the 1970s, including phenazopyridine. Yet in 2003, the agency questioned the safety of phenazopyridine given a study showed it caused tumors in lab rats and mice. The FDA asked for public comments on whether phenazopyridine should have a stronger cancer warning or potentially be limited to prescription-only status. And that wasn’t all. The FDA also questioned, in the same 2003 document, the drug’s usefulness given it doesn’t cure urinary tract infections, only masks the pain and can delay people from getting needed antibiotics. DSM-Firmenich and Target said they both prioritize safety. Walmart declined to comment. The FDA never acted on its own concerns. When asked about the cancer risk recently, an agency spokesperson said the drug should only be taken for two days. Case reports and anecdotes I found online indicate many women are taking it for much longer and sometimes in higher doses than recommended. In these scenarios, the drug can cause people to stop breathing and die if left untreated, according to adverse event reports submitted to the FDA. University of Virginia toxicologists found phenazopyridine has been used in 200 suspected teen suicide attempts over the last 20 years for this reason. My story dives into the system that has led the FDA to be so lax. It might make you think twice the next time you pick up a nonprescription drug. — Anna Edney | 
