How safe are over-the-counter drugs? Many Americans assume that any bottle of pills you can buy without a prescription must not have side effects. After all, the FDA wouldn’t allow easy access to a medication unless it were super safe.
This assumption can get people into serious trouble. Surveys show that some folks using over-the-counter pain relievers like ibuprofen or naproxen think they are safer than prescription pills. Only about 20 percent bother to read the label. Fewer than 30 percent pay attention to dosing instructions. That may explain why nearly a fourth take more than the recommended dose (Journal of Rheumatology, Nov. 2005).
The trouble with such nonsteroidal anti-inflammatory drugs (NSAIDs) is that they do not lose their side effects when they become available on the other side of the drug counter. NSAIDs can cause life-threatening bleeding ulcers, sometimes without advance warning. They have also been linked to an increased risk of heart attacks and strokes.
Even acetaminophen (Tylenol), which is perceived as far safer than aspirin or other NSAIDs, can cause mischief. Some people are especially susceptible to liver or kidney damage. Alcohol magnifies the risk. Some less well-recognized hazards include life-threatening skin reactions, asthma in children and hearing loss in older people.
Pain relievers are not the only pills that can cause problems. When the FDA cleared acid-suppressing drugs like Prilosec (omeprazole) and Prevacid (lansoprazole) for OTC status there was a perception that such heartburn medications were also extremely safe.
These proton pump inhibitors (PPIs) are quite good at shutting down acid production in the stomach. They can ease symptoms of reflux and help heal ulcers. But in recent years there have been reports that people taking PPIs are more prone to pneumonia and intestinal infections (C. diff) because stomach acid helps protect the body against invaders.
Some experts worry that prolonged use of a PPI could lead to weakened bones because of reduced calcium and magnesium absorption. These drugs may also reduce the flexibility of blood vessels, leading to cardiovascular complications. Vitamin B12 deficiency may also be more common if people take PPIs for long periods of time. This can lead to neurological deficits.
The label on such drugs states that people shouldn’t take PPIs for more than two weeks without a doctor’s supervision. But if patients ignore this warning, they may find that stopping such medications can be tricky. That’s because sudden withdrawal may trigger excess acid production as a rebound effect.
The latest development in the OTC sweepstakes could be Lipitor (atorvastatin). There is speculation that Pfizer is preparing to ask the FDA for permission to sell Lipitor without prescription. Will people realize that statins can cause muscle pain, weakness, joint pain, digestive upset, nerve pain, cataracts, diabetes and sexual problems?
We’re not opposed to OTC drugs. We worry, however, that too many people take them for granted. Even over-the-counter drugs can have serious or life-threatening side effects. People need to be well informed of the dangers of all medicines–prescription or OTC–before using them.
