Over-the-counter drugs: A prescription for confusion
At Able Care Pharmacy & Medical Supplies in Enfield, Conn., Ashraf Moustafa often tries to avert disasters involving drugs displayed on his store’s shelves.
Moustafa, the pharmacy manager, recently spoke to an elderly woman seeking ways to treat dark blue patches on her arms. Instead of suggesting any remedies, he asked the woman what medicines she was taking and discovered that she was dangerously mixing over-the-counter anti-inflammatory drugs with aspirin and the prescription blood thinner, Plavix. He sent the woman to the hospital, fearing that she was suffering from internal bleeding.
“People have the impression that if a drug is approved for over-the-counter use, then it must be much safer than prescription medicine,” Moustafa says. “That’s when trouble happens.”
Many consumers mistakenly assume that OTC drugs can do no harm. But when improperly used, these medicines are lethal, killing hundreds of Americans and causing tens of thousands of hospitalizations every year, federal data show.
Greatest risk for elders
Possible risks can easily be overlooked, given aggressive drug marketing and limited patient safeguards. With OTC treatments proliferating and multiple products containing the same potentially dangerous ingredients, searching drug store aisles for appropriate medical remedies can be a prescription for confusion.
Problems with OTC drugs could get worse, as the United States population ages. While people of all ages have been harmed by these medications, elders are at greater risk, because they take more medicine, experience more adverse reactions and have more difficulty understanding health information.
Last year, the Gerontological Society of America and Consumer Healthcare Products Association convened a national summit, calling for research into ways to improve these drug labels and how to better educate patients about these medicines’ potential risks.
Also, the federal government is considering lowering the maximum dose of one potentially dangerous ingredient found in hundreds of OTC drugs: acetaminophen. In January, the government mandated that pharmaceutical companies drop the maximum dose of acetaminophen in prescription drugs to 325 milligrams per tablet.
There’s also growing interest in figuring out how to track what OTC medicines people actually use.
It’s hard to monitor what non-prescription drugs patients buy — let alone take, given that these medications can be purchased in so many stores and online. Many consumers don’t seem to consider these drugs as medicine, pharmacists say. More than half of patients, meanwhile, don’t even tell their doctors what OTC drugs they take, surveys show.
“It’s under everybody’s radar,” says Beverly Schaefer, a Seattle pharmacist and leader in the National Community Pharmacists Association.
Acetaminophen poisoning — and deaths
Acetaminophen, the active ingredient in Tylenol, can be safe and effective when used as directed. When people take just one or two extra tablets a day, though, they can severely damage their livers.
“An elderly person taking large doses of Tylenol for a week can be at risk,” says Dr. Rockman Ferrigno, who chairs Bridgeport Hospital’s emergency medicine department.
Acetaminophen poisoning is the leading cause of acute liver failure in the United States and about half of these liver failures are due to accidental overdoses, medical experts say.
About 150 Americans die from accidental acetaminophen poisoning every year, according to the U.S. Centers for Disease Control and Prevention. Last year, one was a Niantic, Conn., woman, age 51, who suffered from chronic alcohol abuse and had cirrhosis of the liver, according to state medical examiner’s office records.
For acetaminophen, part of the hazard is that it is in so many medications. The most commonly-used drug in America, it is contained in more than 600 OTC and prescription products, including various formulations of Robitussin, Midol, Percocet, Vicodin, Excedrin and Alka-Seltzer Plus.
With the maximum recommended acetaminophen dose set at 4,000 grams a day, the equivalent of eight extra-strength Tylenols, patients could put their health in jeopardy by simply combining the daily allotment of an OTC painkiller with just one prescription medicine.
“If you’re not sitting there with a calculator, adding this up, you can take too much,” says Joan Baird, the American Society of Consultant Pharmacist’s director of clinical affairs. “It’s really easy to do.”
Even some doctors get confused about how much acetaminophen is contained in various prescription drugs, she says.
For the general public, there’s surprisingly little awareness of acetaminophen’s potential danger. Only 31 percent of adults surveyed knew that Tylenol contained the drug, according to a Northwestern University medical school study. Almost everyone was surprised that acetaminophen could cause liver damage, it discovered.
Shopping for medicine can become bewildering, as pharmaceutical companies extend their most popular brands often by varying an original brand name when creating drugs to treat different health problems. For instance, Alka-Seltzer, best known for treating indigestion, contains no acetaminophen. Alka-Seltzer Plus, however, does.
Even consumers who diligently read labels can be misled. Acetaminophen is sometimes abbreviated as “apap” on prescription drug labels. Efforts to stop using the abbreviation are currently underway.
The federal government has begun implementing additional safety measures for acetaminophen. Besides lowering the maximum prescription dose last month, it has mandated stronger liver-damage warnings on all medicines containing acetaminophen and required that the ingredient be more prominently identified on over-the-counter labels.
McNeil Consumer Healthcare, the unit of Johnson & Johnson that produces Tylenol, has made a series of safety changes. It has reduced the recommended maximum dose of 500-milligram Extra Strength Tylenol from eight to six pills a day and launched an interactive website, getreliefresponsibly.com, which allows consumers to type in a drug’s name to see if it contains acetaminophen. Last fall, it began putting warnings on Extra Strength Tylenol bottle caps in red capital letters that said: “CONTAINS ACETAMINOPHEN. ALWAYS READ THE LABEL.”
The changes come against the backdrop more than 125 lawsuits against the company, with many plaintiffs claiming they suffered liver failure from taking Tylenol.
Despite the focus on acetaminophen, public health experts see safety problems with other OTC medicines as well. Sleep aids are a big concern, especially among elders. Many of these drugs, like Nytol, Sominex and Unisom SleepGels contain diphenhydramine, a sedating antihistamine that can cause confusion, dizziness, and increase the risk of falls. Diphenhydramine is on the widely respected list developed by the late Dr. Mark Beers of 53 medications that medical experts contend seniors should not use.
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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