February 22, 2019
OTC Drug Safety

OTC Drug Safety

by Berkeley Wellness  

It’s often surprising to hear the litany of warnings and potential side effects at the end of TV ads for prescription drugs. Similar information appears in print and Internet ads, albeit in tiny type. You can imagine that drug companies would prefer to skip the warnings, which can make people think twice about asking their doctors for prescriptions. But the Food and Drug Administration (FDA) requires direct-to-consumer ads to present a “fair balance” of benefits and risks.

A funny thing happens, however, on the way to drugstore shelves. When those same drugs become available over the counter (OTC), the warnings usually disappear or become marginalized. That’s because oversight of OTC drug ads (though not of the drugs themselves) is handled by another federal agency, the Federal Trade Commission (FTC), which doesn’t require that information about risks be routinely included in ads.

This was the focus of a study by Harvard researchers, supported by CVS Caremark and reported in the Journal of the American Medical Association. It looked at ads for four drugs that went OTC in the last decade: Claritin (generic name loratidine), Prilosec (omeprazole), Xenical/Alli (orlistat) and Zyrtec (cetirizine). After the drugs made the transition, only 11 percent of ads mentioned adverse effects.

OTC drugs usually come in lower dosages than their prescription counterparts, so the risks are reduced, but they still exist. For instance, omeprazole, a proton pump inhibitor (PPI) used for reflux disease, carries a host of potentially serious side effects, especially when used long-term. Notably, it can block the absorption of calcium and thus worsen bone density, as well as interfere with certain drugs and increase the risk of pneumonia. Even common pain relievers such as acetaminophen and ibuprofen (both available only by prescription a few decades ago), as well as aspirin, can have serious side effects.

OTC drugs are a reasonable, convenient and inexpensive way to manage minor, self-limiting problems. But all drugs have risks. Incorrect use of OTC drugs sends thousands of people to the hospital every year and can be deadly. So read the small print on labels and package inserts, where the FDA requires warnings to be listed. Heed warnings about possible side effects and interactions with other drugs, and follow dosage instructions. Don’t take a drug for longer than recommended unless your doctor has okayed it. When in doubt, ask your pharmacist or doctor.