7/1/09 An FDA advisory panel yesterday voted to recommend lowering the maximum daily dosage of acetaminophen – the active ingredient in Tylenol, Excedrin and other popular painkillers – in over-the-counter (OTC) products to reduce the risk of unintentional overdose. Too much acetaminophen is considered a leading cause of liver failure. The vote was held after the committee heard presentations from the public, including one from Pam Snow, an Arthritis Foundation representative who has osteoarthritis. She spoke of the need to increase consumer safety without restricting access to effective pain relief for people with arthritis [her remarks].
Acetaminophen is an effective solution for many people with arthritis pain and is safe, say medical experts, if used properly. It’s widely used by people with arthritis, because it does not have the gastrointesintal (GI) side effects or potential heart health risks associated with nonsteroidal anti-inflammatory drugs, such as ibuprofen (Advil, Motrin) and naproxen (Aleve).
If you currently take acetaminophen for arthritis pain, “Don’t panic,” says Donald R. Miller, professor and chair of the Pharmacy Practice Department at the College of Pharmacy at North Dakota State University and a member of the Arthritis Today medical advisory board. “All they’re trying to do is prevent people from overdosing. Anyone who is currently taking acetaminophen for arthritis shouldn’t have to change anything.”
The panel voted to strengthen and clarify labeling and to limit the maximum single dose of nonprescription acetaminophen to 650 milligrams (mg) from 1,000 mg. Now most OTC acetaminophen products come in 500-mg pills, with directions to take two pills per dose. The 1,000-mg single-dose option would be available by prescription only. Panel members also called for lowering the maximum daily dosage from 4,000 mg (or eight pills, for example, of Extra Strength Tylenol) but did not suggest a new, reduced maximum daily dosage.
Further, the panel called for banning the prescription drugs Vicodin, Percocet and similar pain medications that combine acetaminophen with narcotic pain relievers, such as hydrocodone and oxycodone. Experts have found that consumers who take those drugs are often unaware they contain acetaminophen. As a result, some unknowingly exceed the recommended maximum daily dosage of acetaminophen, risking liver damage.
Acetaminophen overdose resulted in an estimated 56,000 emergency room visits and 458 deaths over an eight-year period, according to a 2006 review of available data. Because the onset of liver damage is difficult to recognize – a key symptom is a flu-like achiness – it is hard to diagnose and treat in its early stages. The FDA panel is recommending changes in the use of acetaminophen because consumers aren’t highly aware of this possibly dangerous connection.
“I think the arthritis community is certainly going to embrace and support any decision that makes the drug safer for them to use,” says rheumatologist John H. Klippel, MD, president and CEO of the Arthritis Foundation. “The other thing to recognize is that of all the pain medication we know of, acetaminophen is not only one of the most widely used, it is clearly one of the safest when used as prescribed.”
Here are some guidelines for taking acetaminophen safely:
- Take the minimum amount of medication necessary. If your recommended dosage doesn’t relieve your pain, ask your doctor for suggestions. Increasing your dosage even a little beyond the current 4,000 mg maximum daily dosage may cause liver damage.
- Be sure you understand dosing directions. Confirm with your doctor or pharmacist how much acetaminophen you can take at one time, how long you should wait between doses and the maximum dosage you can take in one day.
- Check all labels and prescription inserts. Proceed with caution when taking more than one medication that lists acetaminophen as an active ingredient. Spotting acetaminophen can be tricky: In prescription medications, acetaminophen is often identified as APAP when combined, for example, with codeine, hydrocodone or oxycodone.
- Avoid excessive alcohol. People with pre-existing liver disease or those who consume more than three alcoholic drinks a day are at greater risk for liver toxicity when taking acetaminophen. “If you are a regular drinker or you have any kind of previous history of liver problems, that’s when you want to be careful,” cautions Miller.
- Check with your doctor before you stop taking a medication that has been working for you. “I am worried that many of our patients with osteoarthritis are well managed with acetaminophen or acetaminophen and narcotics, especially when they can’t take NSAIDs because of GI complications, and now they’ll stop taking the medication,” says rheumatologist Chad Deal, MD, of the Cleveland Clinic. “When taken properly, these drugs are effective and safe.”
The FDA is not obligated but is expected to follow the panel’s suggestions, although a final decision is most likely several months away.
