Read drug labels carefully
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With questions swirling about acetaminophen, Bruce Bailey, MD, a member of the Backus Medical Staff who is based in the Montville and Colchester Health Centers, said it is important to read the labels and be aware what products have acetaminophen in them.
"This particular issue has just come out, so it is not known yet whether the FDA will put further warnings on packages or may take things off the market, but people need to look at their products and add up the dosage carefully," he said.
Whether or not the FDA takes further action after a committee recommended lowering the maximum dose of non-prescription acetaminophen, people should be aware of the dangers of overdose.
Acetaminophen toxicity is a leading cause of acute liver failure, resulting in an estimated 400 deaths in this country each year. Many of these events are happening because patients are unknowingly taking too much of the drug, because they may not be aware it is in remedies for colds, headaches and fevers. It is also in the prescription drugs Vicodin and Percocet. Or they may take more pills hoping for relief, but they shouldn't take more than the recommended dose.
For example, Dr. Bailey said Tylenol Arthritis is very effective for arthritis patients who may not be able to take ibuprofen, but it is a slow-release medication. When following the instructions on the bottle, patients take 1,300 milligrams every eight hours, which is the maximum dose of acetaminophen. So once they take that, they can't take other medications with this ingredient, such as Nyquil or sleep medications.
Dr. Bailey said parents also need to be aware that dosing is sensitive for children as well. Making sure they don't use different products with the same ingredient is important, as well as making sure the dosage is correct for the child's age and weight.
The panel voted 21-16 to lower the maximum daily dose of nonprescription acetaminophen, which is currently 4 grams - equal to eight pills of a drug such as Extra Strength Tylenol. The panel was not asked to recommend another maximum daily dose.
The panel also voted 24-13 to limit the maximum single dose of acetaminophen to 650 milligrams. The current single dose of Extra Strength Tylenol, for instance, is 1,000 milligrams.
In addition, the panel voted 26-11 to make the 1,000-milligram dose of acetaminophen available only by prescription. Comments can be made through the end of September on this meeting through the FDA.
In April, the FDA required manufacturers to revise labeling for acetaminophen and NSAIDS to include warnings about potential safety risks, such as liver damage, and to ensure the active ingredients are prominently displayed on the packaging and bottles.