Over-the-counter drugs: A prescription for confusion
2/6/2014, 6 a.m.
There’s little evidence showing these OTC pills actually improve sleep, the Gerontological Society of America says. At its National Summit on Sleep Aids and Sleep Health in Older Adults last year, experts pointed out that neither diphenhydramine nor doxylamine, another key ingredient in these pills, has been put through the rigorous clinical trials that the government now requires. That’s because these drugs started being marketed before 1972, when the Food and Drug Administration launched its current regulations of over-the-counter medicines.
Many believe that OTC medications are safe simply because they don’t require a prescription. The illusion of safety is hard to change, given the marketplace and government regulation. Advertising rules for prescription and OTC drugs, for instance, are completely different.
Over-the-counter ads, which are regulated by the Federal Trade Commission, cannot include fraudulent or deceptive statements. That’s a far lower hurdle than the FDA’s rules for prescription drugs, which require company ads to have a fair balance of risks and benefits. As a result, death must be mentioned as a risk in ads for prescription drugs with acetaminophen, but not in ads for OTC acetaminophen products.
There are about 300,000 OTC drugs currently on the market, the Consumer Healthcare Products Association says, and more than 700 prescription drugs have become OTC products since 1976, such as Benadryl, Prilosec and Zantac.
There’s also a move underway to consider making some drugs available without a prescription. The FDA convened a meeting in 2012 to examine the possibility of selling prescription drugs OTC under certain so-called “conditions of safe use.” The prospect of opening the floodgates to even more OTC drugs makes some consumer advocates queasy.
Michael Carome, director of Public Citizen’s Health Research Group in Washington, D.C., worries that some patients are substituting OTC pills for needed medical exams. His group, as well as an FDA medical advisory panel, opposed the FDA’s decision last year to let Oxytrol for Women be sold over-the-counter to treat overactive bladder, which can be a symptom of bladder cancer or diabetes, he says.
Some pharmacists are also warning the public of potential dangers. “You see a lot of strange things,” says Able Care’s Moustafa, who also visits senior centers, where residents bring all their drugs in a bag for him to examine.
For instance, Moustafa has found people who incorrectly assume it is okay to take prescription Nexium along with OTC omeprazole – both designed to treat acid reflux. And he’s discovered many consumers mistakenly taking too many blood thinners simultaneously.
Over and over, consumer advocates offer the same advice to keep patients safe: More is not better, always read drug labels, and don’t self-medicate for too long.
“If you’re taking an over-the-counter medication and things are not improving after a few days, you should have a discussion with your doctor,” Bridgeport Hospital’s Ferrigno says.
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