New Warning Labels for Acetaminophen
New Warning Labels for Acetaminophen
Taking Too Much Could Cause Fatal Liver Damage
Sept. 20, 2002 -- The over-the-counter headache and fever remedy acetaminophen is one of the safest drugs on earth. Yet every year, accidental overdoses lead to tragedy. Now an FDA advisory panel is recommending stronger warning labels for acetaminophen products.
The warnings would urge consumers to take only the recommended doses because exceeding them could cause serious liver damage. An FDA review found that unintentional overdose causes about 100 deaths every year. Current warnings mention liver damage only when mixing acetaminophen with alcohol.
The makers of Tylenol, the most well-known brand of acetaminophen, are voluntarily changing its product labels to say "taking an overdose may cause liver damage."
The panel's meeting this week discussed potential new rules for product labeling. It also considered recommending patient- and doctor-education programs to fight misuse of popular headache and fever medicines. These include acetaminophen as well as aspirin, ibuprofen, and other NSAIDs (non-steroidal anti-inflammatory drugs).
The FDA isn't bound by the advisory panel's recommendations, but it usually adopts them.
"Over-the-counter drugs are still drugs. They have to be very safe to be sold over the counter, but there is no such thing as a totally safe drug," John Jenkins, MD, director of the FDA's office of new drugs, tells WebMD. "We continue to believe these products are safe and effective and should be available over the counter. We just want to improve their safety."
"The focus of the meeting is on ways we can further warn consumers about maximum daily dosing and about how important it is not to exceed the recommended daily dose," Jenkins says. "We also want to identify groups of people we need to warn when they are using the products. [We need to] get consumers to read the container label and to be aware of the ingredients in the medicines they take. It's part of our overall strategy of educating consumers to make wise choices."
The biggest issue is that even a relatively small overdose of acetaminophen can cause fatal liver damage. This is a particular problem for small children, says Karen Plaisance, PharmD, associate professor at the University of Maryland School of Pharmacy in Baltimore. Plaisance recently published a report on acetaminophen and NSAID safety.
New Warning Labels for Acetaminophen
Taking Too Much Could Cause Fatal Liver Damage
Sept. 20, 2002 -- The over-the-counter headache and fever remedy acetaminophen is one of the safest drugs on earth. Yet every year, accidental overdoses lead to tragedy. Now an FDA advisory panel is recommending stronger warning labels for acetaminophen products.
The warnings would urge consumers to take only the recommended doses because exceeding them could cause serious liver damage. An FDA review found that unintentional overdose causes about 100 deaths every year. Current warnings mention liver damage only when mixing acetaminophen with alcohol.
The makers of Tylenol, the most well-known brand of acetaminophen, are voluntarily changing its product labels to say "taking an overdose may cause liver damage."
The panel's meeting this week discussed potential new rules for product labeling. It also considered recommending patient- and doctor-education programs to fight misuse of popular headache and fever medicines. These include acetaminophen as well as aspirin, ibuprofen, and other NSAIDs (non-steroidal anti-inflammatory drugs).
The FDA isn't bound by the advisory panel's recommendations, but it usually adopts them.
"Over-the-counter drugs are still drugs. They have to be very safe to be sold over the counter, but there is no such thing as a totally safe drug," John Jenkins, MD, director of the FDA's office of new drugs, tells WebMD. "We continue to believe these products are safe and effective and should be available over the counter. We just want to improve their safety."
"The focus of the meeting is on ways we can further warn consumers about maximum daily dosing and about how important it is not to exceed the recommended daily dose," Jenkins says. "We also want to identify groups of people we need to warn when they are using the products. [We need to] get consumers to read the container label and to be aware of the ingredients in the medicines they take. It's part of our overall strategy of educating consumers to make wise choices."
The biggest issue is that even a relatively small overdose of acetaminophen can cause fatal liver damage. This is a particular problem for small children, says Karen Plaisance, PharmD, associate professor at the University of Maryland School of Pharmacy in Baltimore. Plaisance recently published a report on acetaminophen and NSAID safety.
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