It’s hard for the Food and Drug Administration to admit that it might have made a mistake. When the agency approved NSAID pain relievers like ibuprofen and naproxen for over-the-counter use, these drugs were perceived as very safe.
The problem is that the risks of medications may not always be obvious. Even before they became available without a prescription, doctors worried about the drugs’ potential to cause bleeding ulcers.
Other consequences of NSAID use appeared more gradually. Evidence has accumulated that such medications increase the risk of heart attacks, high blood pressure, stroke, heart failure and atrial fibrillation (Expert Review of Cardiovascular Therapy, October 2014).
Unfortunately, these problems are more likely to be troublesome among older people, the very folks who are prone to aches and pains. Recently, researchers have found that NSAIDs also seem to increase the chance of falls among elderly individuals (Consultant Pharmacist, 2015).
If the FDA had known all of this up front, perhaps these drugs would not be available in supermarkets and gas stations all over America. But it may be too late to put the genie back in the bottle and restrict ibuprofen and naproxen to prescription use only.
This pattern has been repeated in the case of the popular acid-suppressing drugs called proton-pump inhibitors (PPIs). Drugs like omeprazole (Prilosec) and lansoprazole (Prevacid) were initially available by prescription only for serious gastrointestinal problems such healing ulcers, treating erosive esophagitis and easing a rare condition called Zollinger-Ellison syndrome.
Before long, though, doctors were using them to treat heartburn symptoms. PPIs have become among the most widely prescribed drugs in the world. In the U.S., it is estimated that more than 20 million people receive prescriptions for powerful acid-suppressing drugs every year.
Once these powerful medicines went off patent, the manufacturers requested OTC status as Prilosec OTC, Prevacid 24HR and Nexium 24HR. The FDA approved the switch on the grounds that these drugs were very safe. Now, however, the dark sides of PPIs are coming to light.
The most recent research shows that these medications boost the chance of a heart attack by about 20 percent (PLOS One, June 10, 2015). This may not sound like much, but when you consider how many millions of folks take these medications, it adds up to a lot of additional heart attacks.
This is not the only problem that has been linked to PPI use. These drugs also are associated with an elevated possibility of broken bones, especially hip fractures (Annals of Epidemiology, April 2014).
People taking acid-suppressing drugs also are more susceptible to pneumonia, with a 50 percent increase in risk (PLOS One, June 4, 2014).
Nor are lung infections the only problem. People taking PPI medicines are more likely to contract Clostridium difficile, an intestinal infection that can cause life-threatening diarrhea (American Journal of Gastroenterology, July 2012).
People like having access to powerful medications for symptom relief. But they need to inform themselves carefully about possible risks. OTC drugs sometimes trigger serious or even life-threatening complications.
Joe Graedon is a pharmacologist. Teresa Graedon holds a doctorate in medical anthropology and is a nutrition expert. Their syndicated radio show can be heard on public radio. In their column, Joe and Teresa Graedon answer letters from readers. Write to them at PeoplesPharmacy.com.