While the FDA continues to sort this out, the takeaway message for patients, Fishman says, is that "doctors need to talk with patients about this when they prescribe it." He adds: "This is a drug that should only be used with a patient-physician relationship."
* Acetaminophen "is a safe medicine if taken properly," Gallagher says. A primary concern about acetaminophen, Gallagher and other experts say, is that it's in so many products—from OTC pain medicines like Tylenol to certain combination allergy, sinus, and cold medications, some OTC sleeping aids and certain prescription opioids, such as Percocet (acetaminophen and oxycodone) and Vicodin (acetaminophen and hydrocodone). That means that if you're taking OTC acetaminophen for occasional pain, you need to check the labels of any additional medication to be sure you're not taking too much.
Indeed, McNeil Consumer Healthcare, the maker of Tylenol, made this point in a statement posted on its website following the FDA's public meeting on acetaminophen in late June. The company advises reading drug labels and following directions, not taking more than the suggested dose, and never taking more than one acetaminophen-containing product at one time. In addition, the drug's label warns that people who consume three or more alcoholic beverages per day should consult their doctors about whether it's safe to take Tylenol because of the concern about liver damage. Symptoms of liver damage include nausea, vomiting, and loss of appetite—which, the FDA warns, can be mistaken for the flu. If you suspect liver problems, seek prompt medical attention because it can quickly progress to liver failure, or even death, within several days, according to the FDA. Also, if you already have liver disease, or if you take the blood thinner warfarin (which, taken along with acetaminophen, can increase the risk of bleeding), talk to your doctor before taking any medication containing acetaminophen.
Paying attention to drug labels and knowing what's in your medications before adding another one are particularly important among the elderly, who "will be more likely to have chronic pain, first of all, but also need pain medications to help function at a higher level," Gallagher says. People taking multiple meds might consider developing a running tally, such as this one provided by the American Society of Health-System Pharmacists. (The FDA offers this tip: Acetaminophen is sometimes abbreviated as "APAP" on prescription drugs. And in countries other than the United States, acetaminophen may be known by a different name.)
Earlier this year, the FDA called for manufacturers of drugs containing acetaminophen to add stronger warning labels about the risk of liver damage. In June, an FDA advisory panel voted in favor of lowering the maximum daily dose of OTC acetaminophen from its current level of 4 grams—or about eight pills of Extra Strength Tylenol—but did not specify a new recommended maximum daily dose. The FDA says that taking just slightly more than the maximum recommended daily dose of acetaminophen can lead to liver injury because the currently recommended 4 grams per day leaves only a small margin of error. The FDA panel voted in favor of limiting the maximum single dose of this drug to 650 milligrams, compared with the 1,000 milligrams of acetaminophen a person would consume when taking two Extra Strength Tylenols, for example. The panel voted in favor of making a 1,000-milligram dosage available only by prescription.
The advisory panel also voted for a ban on Vicodin and Percocet, stemming in part from a concern about the potential for abuse and many people's tendency to take more of these medications than recommended because of a mistaken assumption that consuming more of these drugs will provide better pain relief without an increased risk of adverse health effects. The panel encouraged banning the drugs in their current form, as combination opioid-acetaminophen products. "The advisory board was suggesting that they only be made available separately," meaning that hydrocodone and oxycodone should be sold only as single drugs, rather than in combination with acetaminophen, Fishman says. The FDA typically follows the recommendations of its advisory panel, though not always, as in the case of propoxyphene.
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