RODALE NEWS, EMMAUS, PA—Acetaminophen is one of the most popular over-the-counter painkillers in the U.S., primarily because it doesn’t irritate stomachs the way that aspirin and ibuprofen can. It’s used in a variety of medications, from Tylenol to Dayquil Sinus, but overdosing on it can lead to serious liver damage. At a meeting that took place earlier this week, a U.S. Food and Drug Administration advisory panel found that the risks of acetaminophen-related liver damage are so serious, and the public so unaware of them, that major steps need to be taken. Some say they’re overdue. “Thirty-two years ago, the FDA recommended that there be strong warnings on acetaminophen products, and those recommendations were finally put in place three months ago,” says Sidney M. Wolfe, MD, director of the Health Research Group of Public Citizen and the consumer representative on the advisory panel. “Huge numbers of people have died from acetaminophen liver toxicity, and they wouldn’t have if the FDA had moved on its recommendations.”
THE DETAILS: Too much acetaminophen can cause the liver to produce a toxic metabolite that binds to liver proteins and damages cells, and you may be overdosing on the drug without realizing it, says the FDA. Cases of acetaminophen overdose often result from a person taking more pills a day than she should, or by combining products that contain acetaminophen without realizing it, usually a prescription product containing acetaminophen plus an over-the-counter drug like Tylenol. According to a 2005 study published in the journal Hepatology, acetaminophen-related liver injuries were the leading causes of acute liver failure from 1998 to 2003, and among patients in the study, nearly half overdosed on the drug without realizing it.
At this recent meeting, the advisory panel proposed lowering the current recommended maximum dosage, 4 grams, because exceeding that even by a small amount can lead to liver damage. They also recommended lowering the maximum levels of acetaminophen found in over-the-counter pills from 500 milligrams to 325 mg.
For prescription products containing acetaminophen, the panel recommended improving labeling. Currently, acetaminophen is listed as on many prescriptions as “APAP.” The panel also proposed a ban on Vicodin and Perkoset, two powerful painkillers that combine narcotic ingredients with acetaminophen. The problem with these, says Dr. Wolfe, is that people become tolerant to the amounts of narcotics in those pills, and doctors have to up the dose of narcotics to keep them from working. “But it’s a fixed combination, so if you increase the dose of a narcotic, you also increase the dose of acetaminophen.”
WHAT IT MEANS: If you’re a careful label-reader and aren’t on prescription painkillers, you likely won’t have anything to worry about. But people who take prescription meds should pay careful attention, especially those who use OTC pain relievers. The 2005 Hepatology study found that more acetaminophen poisonings occurred when patients combined prescription and over-the-counter drugs, not when patients combined more than one acetaminophen-based over-the-counter drug. The symptoms of liver damage are hard to identify and often mimic the flu, making injury difficult to diagnose. Compounding the threat is the fact that available treatments aren’t as effective when acetaminophen poisoning has progressed too far. Furthermore, some people are more susceptible to liver damage from acetaminophen, even if they stay within the recommended range—for instance people who drink alcohol or suffer from liver disease.
While experts work out new guidelines, here are some important precautions to take:
• Know where to find it. Acetaminophen is a main ingredient in Tylenol, Excedrin (which combines acetaminophen with aspirin in many of its products), generic versions of those pills, and many cold, sinus, flu, and allergy medications. You can find out if it’s in your prescription medications by searching the database at Public Citizen’s worstpills.org.
• Continue to read labels. Look for the “Active Ingredients” box on the drug label, and see if acetaminophen is listed. If so, avoid other medications, whether prescription or over-the-counter, that contain it.
• Stick to the recommended amount. Taking more pills for a bad headache isn’t likely to eradicate the bad headache—but it can kill your liver. Read the directions, and do what they say. Talk to your doctor if you’re not getting relief.
• Speak up. Whenever your doctor or pharmacists asks you what medications you’re taking, tell them everything—even if it’s an occasional Tylenol for knee pain or other seemingly inconsequential ailment. If you have a lot to keep track of, make a list you can refer to.
• Ask questions. Ask your pharmacist what the active ingredient is in the medication you’re taking, and tell him or her if you’re worried that it might interfere with common painkillers you also take.
• Avoid combo meds. “We always recommend against these combination medicines for cough and cold,” says Dr. Wolfe. “Most people do not have multiple prominent symptoms.” Rather than go out and buy something like Nyquil, which has four active ingredients, use a nasal spray or drop that’s meant to treat the symptom you actually have. You’re exposed to less medicine, which is much safer, he adds. “You take a tiny amount and put it where it needs to go."