It’s hard for the FDA to admit it might have made a mistake. But when it comes to OTC pain relievers and heartburn pills, that seems to be the case. 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 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, Oct., 2014).
Are Older People at Higher Risk Of NSAID Injury?
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.
PPI Problems
This pattern has been repeated in the case of the popular acid-suppressing drugs called proton pump inhibitors (PPIs). Drugs like omeprazole (Prilosec) or 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 over 20 million people receive prescriptions for powerful acid-suppressing drugs every year.
PPIs Are OTC
Once these powerful medicines went off patent, the manufacturers requested OTC status as Prilosec OTC, Prevacid24HR and Nexium 24HR. The FDA approved the switch on the grounds that these drugs were very safe.
Serious Side Effects of PPIs
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 are also associated with an elevated possibility of broken bones, especially hip fractures (Annals of Epidemiology, Apr., 2014).
People taking acid-suppressing drugs are also 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).
Many people take a PPI to protect their digestive tract from the damage that an NSAID pain reliever can do. As we have written, that may not achieve the desired effect. Although PPIs can help protect the stomach, they leave the small intestine vulnerable to injury (Mayo Clinic Proceedings, Dec., 2014). No one knows if the excess risk of heart attack from this combination might be greater than the danger from either drug alone.
Using Over the Counter Medicines Wisely
People like having access to powerful medications for symptom relief. But they need to inform themselves carefully about possible risks. OTC pain relievers and heartburn pills sometimes trigger serious or even life-threatening complications.
