Making sense of the FDA's acetaminophen recommendations

Last week, a Food and Drug Administration joint advisory committee made several recommendations about the painkiller acetominophen. The panel proposed:

• Lowering the maximum daily dose to 2,600 milligrams from 4,000 mg.
• Limiting the amount in a single over-the-counter pill to 325 mg, from 500 mg currently.
• Banning sales of prescription pain relievers that combine opioids with acetaminophen, including Percocet and Vicodin, among the most widely prescribed drugs in the U.S.
• “Extra strength” doses - equal to two 500-milligram pills - be switched to prescription only.
• The largest dose available over the counter be limited to two 325-milligram pills.
• Infants’ and children’s doses be standardized to prevent errors.
• Propoxyphene, also sold as Darvon and in an acetaminophen combination called Darvocet, has been linked to accidental overdoses and suicides. The prescription medication will now come with a pamphlet describing the risk.

What prompted the FDA to make this recommendation?

According to the FDA, prescription acetaminophen combination drugs were prescribed 200 million times last year. Tylenol's maker says nearly 50 million U.S. adults and children take acetaminophen in any given week. Cases of acute liver failure and deaths related to acetaminophen have been increasing. An FDA memo reports an estimated 110,000 emergency room visits a year are related to acetaminophen, and several hundreds cases of acute liver failure are also reported. Of all acute liver failure cases, about half were accidental. This is not a problem that is limited to drug addicts. Also, acetaminophen is the No. 1 reason people need liver transplants for acute liver failure.

Why are acetaminophen injuries on the rise?

Drug strength has increased, and labeling is not clear. It’s easy to take more than the recommended daily dose without realizing it. People are unaware that acetaminophen is in many medications. The margin between a safe dose and a potentially lethal one is small.

It’s safe as instructed—but if you’re taking Percocet for your lower back pain, and Tylenol for your headache, and cough syrup three times a day and then you can’t sleep so you take an over-the-counter sleep aid, you are taking a lot more than you are aware of. Some people don’t even consider Tylenol a drug, so they don’t tell their doctors.

Even the most conscientious patients may not be aware of how much acetaminophen is in their prescription pain reliever because it is often labeled as APAP—an acronym for its chemical name, N-acetyl-para-aminophenol. The FDA in 2004 asked state pharmacy boards, which oversee labeling for prescription drugs, to require acetaminophen to be listed by name on the bottle, but so far, none have complied.

What products contain acetaminophen?

The prescription medications Vicodin and Percocet as well as 300 over-the counter medications NyQuil, Excedrin and Tylenol cold and flu. Many drugs that say "cold and flu" probably have acetaminophen for muscle pain and fever reduction.

What is the recommended until the official action is released?

• Don't combine drugs that contain acetaminophen and inform your doctor if you have liver problems or drink alcohol daily.

• You should tell your doctor or pharmacist about all the medicines you are taking. Read ingredient labels and follow directions exactly. Don't use more than the maximum dose in any given 24-hour period or go beyond the maximum days unless you have spoken to your doctor about it.
  

• The first symptoms of acute liver failure caused by an overdose seem like the flu and don’t set in for several days, by which time it may be too late to save your liver and consequently your life.

As a precaution, should consumers switch to other types of over-the-counter pain relief?

Over all the risk of acetaminophen to any individual is low. Alternative over-the-counter products like aspirin and ibuprofen have side effects of their own. Far more people are harmed by regular use of aspirin and ibuprofen, which belong to a class of medicines called nonsteroidal anti-inflammatory drugs, or Nsaids. By most estimates, more than 100,000 Americans are hospitalized each year with complications associated with Nsaids. And 15,000 to 20,000 die from ulcers, kidney failure, hypertension, and internal bleeding linked to their use.

Nearly everybody on the panel recognizes that from a public-health perspective, Nsaids are much more concerning than acetaminophen. From what my clients say, taking Aleve (Naproxen) occasionally tends to be the most well-tolerated of all the OTC pain medication.

Non Pharmacological Options?

Any changes you wish to make to your painkilling medication regimen must be discussed with your physician first.

• Limbrel (by prescription only) - high dose flavanoid complex derived exclusively from the plant sources skullcap and acacia; several clients have spoken highly of its efficacy.

• Metagenics Kaprex - similar to Limbrel but a prescription is not necessary.
  

• Cod Liver Oil - its vitamin D and omega-3 content have anti inflammatory properties.

• Pain Relief Diet Action Plan - if food is causing the pain, our action plan will get to the bottom of the culprits.