Your nose is stuffed and you can’t breathe. Your cough is so bad it’s vibrating the windowpanes. And your head is pounding with hurricane force.
The answer to your problems, you hope, is at the local drugstore, where the shelves bulge with over-the-counter relief medications.
But before you grab a product, run home and slug down a dose every four hours, take time to check the label carefully, particularly the list of inactive ingredients and health warnings. There may be something lurking in those seemingly safe antacids and pain and cough relievers that could make you feel worse rather than better.
A survey conducted by the Yankelovich Monitor in August 1998 asked 1,000 consumers about non-prescription pain relievers and found that 50 percent of the population does not read the label, says Janet Engle, a member of the board of trustees for the American Pharmaceutical Association.
“The same survey showed that one-third of people believe there is no risk associated with over-the-counter pain relievers, so they don’t understand the benefits and risks,” she says.
“Over-the-counter drugs are safe, but they have to be treated with the same respect as prescription drugs. They’re only safe if taken as directed.”
Consumers must be aware of the potential side effects of OTC drugs, or the possibility that they can interact with other drugs or affect an existing medical condition.
Although much of this information is included on the medication package, it may be difficult to understand or hard to read because of the small print.
In addition, too many consumers have a lackadaisical attitude toward over-the-counter medicines, assuming that if they have been approved by the Federal Drug Administration they aren’t likely to be harmful.
That can be dangerous thinking.
“I had an elderly patient who was told to take acetaminophen for dental pain,” Engle says. “She bought a PM product and didn’t realize it contained a sleep aid. She took it every four to six hours, but it was too much for her and she ended up falling and breaking her hip.”
Currently, there are more than 300,000 OTC drugs on the market, according to information supplied by the Mayo Clinic. Over-the-counter status may be sought for medications when a drug manufacturer’s patent rights expire.
Although OTC drugs are safe and effective for the average person, their ingredients can be harmful.
Besides the active ingredients in over-the-counter medicines, these products teem with additives called non-medicinal ingredients, or NMIs. Some are fillers that bulk up the medicine, allowing it to be formed more easily into a capsule or a tablet.
Other drugs contain dyes, sweeteners to make them taste better, or binders. Many drugs have added alcohol, caffeine, aspirin and sodium — all of which potentially can cause adverse reactions.
If you select Excedrin Aspirin-Free for that late-evening head-banger, for example, don’t expect to get much sleep. That product contains caffeine.
The box lets you know this, but it’s written in tiny print.
“If you take it right before bedtime, it will keep you awake,” says Louise Parent-Stevens, assistant professor at the University of Illinois at Chicago College of Pharmacy. “It also could cause jitteriness if you’re sensitive to caffeine. Or it could cause withdrawal headaches if you take a lot of it and then stop suddenly.”
Engle tells of a patient who came into her pharmacy one day looking for a sleep aid because she was awake all night. After quizzing her about her medications, Engle learned that she had been taking a pain reliever that contained a large amount of caffeine, but the patient had failed to note that on the label.
“So the patient didn’t need a sleep aid, she just needed a pain reliever without caffeine. If she hadn’t talked to me, she would have been taking a drug she didn’t need to counteract a side effect of an additive.”
Hidden caffeine in OTC products also can exacerbate symptoms in women with premenstrual syndrome, says Parent-Stevens. “They may not be aware of what is making their symptoms worse.”
She notes that an Anacin tablet lists 32 mg of caffeine, which is close to the amount of caffeine you would get in a cup of tea or hot chocolate. (A cup of brewed coffee, by comparison, has 100 to 200 mg of caffeine, depending on how strong you make it.)
Following are other “hidden” ingredients you should watch for:
ALCOHOL
Don’t be tempted to dose your child with smaller amounts of the cough or cold syrups formulated for adults. Some products, such as Nyquil, list alcohol as their first inactive ingredient. Vicks 44D also lists alcohol, yet it gives recommended dosages for children as young as age 6. Neither product states the amounts of alcohol contained within, which is 10 percent for Nyquil and 5 percent for Vicks 44D.
Although the amount of alcohol in these syrups may not be enough to intoxicate an adult, if given to a child every four to six hours, the medicine could adversely affect him.
OTCs with alcohol also could be a problem for adults who struggle with alcoholism.
One emergency room physician reports seeing acetaminophen overdoses that result when people drink OTC products for their alcohol content, not realizing they are taking in other active ingredients. Such overdoses could adversely affect the liver.
ASPIRIN
Often listed as acetylsalicylic acid, hidden amounts of aspirin in OTC medicines can spell trouble for children and adults.
Most parents are well aware that children shouldn’t be given aspirin because of its connection with Reye’s syndrome, a life-threatening disorder affecting a child’s blood, liver and brain that is thought to be triggered by aspirin. A parent may not know, however, that products such as Pepto-Bismol contain as much as 30 mg of salicylate, an aspirin derivative.
“I have a friend who gave her daughter Pepto-Bismol while the child had chicken pox,” says Parent-Stevens. “She had no idea that it contained aspirin until she mentioned it to her doctor, and he told her not to use it.”
Aspirin also can be a problem for people with gout, a painful condition that occurs when uric acid crystals accumulate in the affected joint, often the big toe.
“Aspirin can increase uric acid levels, depending on the dosage taken,” says the professor.
OTC drug labels give long lists of warnings to avoid their products if you have heart disease, diabetes, gout and so on. Yet consumers find it all too easy to dismiss these cautions because the drugs are as accessible as tomatoes and zucchini.
DYES
Many manufacturers list the dyes used in their products, but consumers usually aren’t aware of those that may cause adverse reactions. One yellow dye, called tartrazine, can cause severe allergic reactions in some people, including a rash, tingling of the mouth, headache and even an asthmatic attack. If you have concerns about dyes, it is best to seek out OTCs that are clearly labeled “dye-free,” such as some Benadryl.
BINDERS
Binders are ingredients that hold the drugs together in tablets. One that is frequently used is lactose. It can be found in the multivitamin Centrum Jr., for example, and in Nytol, a sleep aid. People who are lactose-intolerant and take a large quantity of the product may suffer gastrointestinal distress, similar to the reaction they’d get if they drank milk.
SODIUM
Alka-Seltzer is the classic example mentioned in regard to sodium, Parent-Stevens says. “The antacid it contains is a sodium bicarbonate. That’s fine if you don’t have problems handling sodium. But it’s not a great antacid for someone with high blood pressure or heart disease.”
The Alka-Seltzer label lists 1,916 mg of sodium bicarbonate as well as 325 mg of aspirin.
Better antacids for sensitive consumers would be products containing calcium carbonate, such as Tums and Rolaids.
PRESERVATIVES
The preservative povidone, which is iodine, is added to many OTC tablets, as well as eye drops, to keep bacteria levels down. “People allergic to iodine can have a severe allergic reaction if they take anything with povidone in it,” says Wal-Mart pharmacy manager Edna Fusco. Povidone (as well as lactose) can be found in Tavist-1, an antihistamine.
SUGAR
Dentists have reported increased cavities among children who are given high doses of sugar-containing cough syrups.
“Sugar also can be an issue for some diabetics who are taking a lot of medications,” Parent-Stevens says. “It tends to be more of a problem in the liquids, which contain sugars such as glucose or corn syrup as sweetening agents.”
Triaminic DM, for example, contains sucrose but also gives a warning to diabetics not to use this product.
COMBINATION PRODUCTS
Another potential problem among over-the-counter medications lies in combination products that promise to treat a cough, cold, sore throat, headache and numerous other maladies. People may not realize that many contain an analgesic such as Tylenol. If they then give their child a lot of Tylenol on top of the other medication, it could endanger the liver.
Children’s Tylenol Cold Multi-Symptom Plus Cough contains 160 mg of acetaminophen. A standard tablet of Children’s Tylenol, by comparison, has 80 mg of acetaminophen per tablet and calls for four tablets for children ages 6-8.
“This is one of my biggest concerns,” says Engle, associate dean for academic affairs at the University of Illinois at Chicago College of Pharmacy. “If a parent uses a product such as Triaminic Sore Throat Formula combination and she doesn’t realize it has acetaminophen in it, she may end up double-dosing her kids.”
DRUG INTERACTIONS
If you are taking prescription anticoagulants, then ingest aspirin hidden in an OTC product, it may act as a blood thinner, affecting the platelets important in blood clotting.
Engle, who formerly ran an anticoagulation clinic, had a patient who bought Doan’s pills for back pain, not realizing they contained an aspirin derivative (magnesium salicylate tetrahydrate). Fortunately, Engle was able to warn him before he took too many.
Consumers who take medicines for high blood pressure may be at risk if they take decongestants containing pseudoephedrine or phenylpronanolamine, Fusco says. These ingredients could counteract the antihypertensive effects of some blood pressure medications.
Decongestants such as Sudafed can increase blood sugar levels.
“In December, I treated a woman who was taking Sudafed for congestion on a regular basis,” Parent-Stevens says. “She was a diabetic, and her sugars had gotten elevated. She couldn’t figure out why, and she tried changing her diet but it didn’t help. When we went over her medications, we figured out that the problem was caused by the Sudafed.”
Consumers who would like to identify the inactive ingredients in various over-the-counter medicines can ask their pharmacist to check for them in a book called “Facts and Comparisons.” The reference lists fillers and dyes and also can tell people which products are sugar-free, alcohol-free, aspirin-free and caffeine-free.
Children’s Sudafed, for example, is available alcohol-free and sugar-free.
Children’s Vick’s Nyquil has no alcohol or aspirin but does contain sucrose.
Although many NMIs already are listed on the boxes or informational inserts of OTC medicines, they can be difficult to read or understand. Soon product labels will be clearer.
Health and Human Services Secretary Donna Shalala announced on March 11 an FDA regulation to provide new labeling for non-prescription drugs. Drug manufacturers must comply within six years. This change will help consumers to better identify an OTC drug’s benefits and risks.
“The impetus is to make labeling for consumers more uniform, a label with a drug facts format that includes all the information in the same place,” says Linda Katz, deputy director of over-the-counter drugs for the FDA.
READING THE FINE PRINT
Always read the label on non-prescription drugs, recommends the American Pharmaceutical Association. Here’s what it will tell you:
The conditions or symptoms the medicine treats.
How much medicine to take, how often and for how long.
What side effects may result from the medicine.
What activities to avoid when using the medicine (driving, for example).
Which health conditions might preclude you from using the medication, such as asthma, high blood pressure, diabetes or pregnancy.
Whether you should avoid certain foods, drugs or alcohol while taking the medication.
– Verna Noel Jones
HAS MEDICATION BOTHERED YOU?
The Food and Drug Administration wants to know if you’ve had a severe adverse reaction to an over-the-counter medication.
The FDA’s MedWatch program, which monitors adverse events and problems with medical products, considers a problem serious if the outcome led to a death, a life-threatening situation, admission into a hospital, a permanent disability, a birth defect or medical care to prevent permanent impairment or damage.
To report a problem to MedWatch, call 1-800-FDA-1088 to request a reporting form. A form also can be downloaded at www.fda.gov/medwatch/how.htm.
Verna Noel Jones
