Twenty-seven years after the still-unsolved Tylenol murders comes a fresh warning that over-the-counter painkillers can kill. Tamperproof packaging won't save us this time. We're poisoning ourselves.
Overdoses of acetaminophen, the active ingredient in Tylenol, send 56,000 people to emergency rooms every year and kill roughly 200. It's the leading cause of liver failure in the U.S.
A panel assembled by the Food and Drug Administration recommended last week that the maximum daily dosage be lowered and that prescription drugs - including Percocet and Vicodin - containing acetaminophen with other painkillers be withdrawn from the market. The panel said that if the drugs remain on the market, they should carry a "black box" warning on the label.
Like aspirin before it, acetaminophen has been hailed as a wonder drug, safe and effective when taken as directed. Tylenol long ago replaced baby aspirin as the kid-friendly analgesic of choice, mostly because of aspirin's link to Reye's syndrome. Adults are routinely steered to acetaminophen to avoid gastrointestinal problems caused by aspirin or ibuprofen.
Its role as a first-defense painkiller (and the fact that it comes in candy-flavored liquids for kids) makes it easy to dismiss as innocuous - an all-too-common attitude when it comes to over-the-counter drugs. If it's out here next to the Kleenex and the toothpaste, it must be safe, right? And if it takes two every four hours to defeat a garden-variety headache, then this doozy needs four every two hours, at least. Down the hatch.
Consumers who actually read the labels often find them confusing, especially with the multisymptom cold-and- flu cocktails. There are the antihistamines that make you sleepy and the ones that don't, the decongestants you can buy off the shelf and the ones you can't, and a frightening amount of overlap among products marketed for sinus and allergy, cold and cough, arthritis and sleeplessness.
Surveying the inventory in your medicine cabinet at midnight, you might be tempted to improvise. Does DayQuil plus Advil PM equal NyQuil? (No.) And even if you know better, you may reach for the Robitussin Night Time Cough Cold & Flu to silence a cough, never mind that it doubles the dose of acetaminophen you took a few hours ago.
That's the sort of behavior that convinced the FDA's panel that we need to be saved from ourselves. But its cure may be worse than the symptoms. Percocet and Vicodin are widely prescribed to treat severe pain - roughly 200 million times last year - and the vast majority of patients follow directions and are grateful for the relief.
Attempting to control over-the-counter acetaminophen by making the "extra strength" tablets available only by prescription will make it more costly and inconvenient, which just encourages people to take four (or six) regular-strength tablets at a time instead of two.
Putting a scary label on the packages is a pretty good idea, along with an aggressive public awareness campaign, which is, we hope, what these recommendations will accomplish. It shouldn't take a cyanide scare to make people think twice about how many pills they're popping.