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Acetaminophen Safety: How Safe is Tylenol’s Active Ingredient?

Acetaminophen, the active ingredient in Tylenol, is an over-the-counter drug that many people think is benign. It’s been regarded as safe enough to use through pregnancy. As someone who used to pop large numbers of OTC painkillers each day, I’m increasingly horrified when new information comes out about the safety risks of acetaminophen. Most people don’t take high enough doses to be in danger, but people with headache disorders or chronic pain are at risk of taking too much without even knowing it. The risk isn’t necessarily in long-term use; exceeding the maximum daily dose in one 24-hour period can cause severe liver damage.

This infographic from the University of Florida’s pharmacy program highlights some of the risks and dangers of acetaminophen. If you’re concerned about your acetaminophen use, please talk to your doctor about alternatives. Some of the alternatives recommended below, like NSAIDs and opioids, also have limits to how often they should be taken; many opioids are packaged in pills that contain acetaminophen, which negates their use as an acetaminophen substitute.

(Click anywhere in the infographic for a larger, easier-to-read version.)

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Potential Liver Damage When Combining Caffeine and Painkillers

My response to Painkillers, Caffeine May Cause Liver Damage, a post on Somebody Heal Me, was much stronger than “Oh darn.”

[P]reliminary research indicates that people who take in large quantities of painkillers containing acetaminophen [Tylenol] and ingest large amounts of caffeinated beverages may be at increased risk for liver damage. Migraine medications that intentionally mix acetaminophen and caffeine are also suspected of increasing the risk of liver damage when taken in large quantities. This would include over the counter medications such as Excedrin and prescription medications such as Fioricet. The danger is similar to that of consuming alcohol and acetaminophen, which scientists have warned about for many years.
(emphasis mine)

Knowing how effective acetaminophen and caffeine are for many people with headache, the research deserves consideration. I’m especially interested what role drinking caffeine (or eating caffeinated doughnuts) may play.

Caveat: This study used very high doses of both caffeine and acetaminophen. Still, the potential toxicity of acetaminophen — with or without caffeine — should not be overlooked. Overdoses of products containing acetaminophen account for 40 to 50% of all acute liver failure cases each year in the United States. If you ever take acetaminophen, please read Toxicity and Tylenol to understand the dangers.

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This Time Last Year, March 11-17

Posts from The Daily Headache, March 11-17, 2006

Reporting on Narcotics & Headache: What a Mess
A look at an article in ABC’s three-part series on migraine that I was really upset by. Reviewing the article, I saw something that now makes a lot of sense to me:

“. . . Long-term use of narcotics can actually magnify headache pain and could render other treatments ineffective.

“‘Not only does it deplenish your own natural painkillers,’ he said, ‘but it destroys parts of the brain that are responsible for fighting pain.'”

The story clearly wasn’t as awful as my gut reaction indicated.

Preliminary Results for PFO Closure Trial
The MIST study examining whether closing a hole in the heart is an effective migraine treatment reported mixed results, depending on the journalist’s perspective.

ABC on Migraine: It Gets Worse
The final installment of the series looked at a nasal surgery that some are using to treat migraine. This same surgery was ineffective for me (and for many others, I have since learned), so I’m skeptical of it. The article’s author does describe unfavorable opinions of the surgery.

Toxicity of Tylenol
Acetaminophen is far from benign: Overdoses of products that contain acetaminophen account for 40 to 50% of all acute liver failure cases each year in the United States.

Healthcare Provider of the Year
The National Headache Foundation‘s call for entries for this award. I can’t find who won last year, but I did see that nominations were requested for this year — but were due yesterday. Sorry, it’s the first I heard about it.

Pill-Taking Woes Resolved
A handy dandy gadget for pill swallowing ease.

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A Headache Specialist’s Comments

Christina Peterson, a neurologist (and migraineur), is a blog reader who leaves terrific, educational comments. I always learn a lot from her. Some of her comments on recent posts are so informative that I want to be sure you all see them.

Warnings Proposed for OTC Painkillers

This is a really important post–it can’t be overstated.

In fact, the NYT article, if anything, understates the matter. The truth is that at this time, over 50% of all liver transplants are necessary because of the medical use of acetaminophen. It’s such a big problem that even the makers of Tylenol have run a commercial asking people not to exceed the recommended amount.

Gastritis and ulcers are no fun, and most people have been made aware of the cardiac and blood clot risks of anti-inflammatories like Vioxx and Celebrex, but a lot of people tend to think that ibuprofen and acetaminophen are benign.

They aren’t.

It’s also important to know that a lot of prescription analgesics, like Vicodin, Percocet, Fioricet, Amidrin (and all their generic names), also contain acetaminophen–so don’t double up.

If you are an intermittent migraine sufferer, and not a chronic headache sufferer, a double-blind randomized controlled trial has established that acetaminophen has no role in the treatment of acute migraine. There are better options available.

Men & Women Experience Pain Differently

This is vastly oversimplified. (Well, OK, it’s a newspaper…) But I trust this blog readership to be more sophisticated than the sixth grade level general readership a newspaper shoots for. So.

Most of the studies that have recently emerged have indeed shown a difference in pain processing between men and women. The major difference is that pain processing in women fluctuates with estrogen levels. (Estrogen–it’s our theme of the week, isn’t it? 🙂

Some of the studies available are simplistic and misleading–lab animals were injected with estrogen, and pain thresholds decreased, which led researchers to conclude that therefore, women were weak, and couldn’t tolerate pain as well as men. (Can anyone say, “Researcher bias”?)

But if you think this through, it is counter-intuitive. It makes no sense. Pregnant women have very high estrogen levels–estrogen levels climb throughout pregnancy, until they are very high by the time labor begins.

And menstrually-associated headaches occur when estrogen levels are at their lowest–the day before menstruation begins is the most common day for a menstrual migraine, and that is the day for a drop in estrogen.

Dr. Nancy E.J. Berman, who has done very important research on the effects of hormones on trigeminal neurons and the effects on orofacial pain, TMD, migraine and fibromyalgia, and who won the Wolff Award this year from the American Headache Society, also wrote the chapter on “Sex Hormones” in the book, The Headaches. She has noted that migraine improves both during pregnancy, when estrogen is high, and after menopause, when estrogen is low. She feels that this suggests that it is rapid changes in estrogen and progesterone that serve as a trigger for migraine attacks.

Some studies suggest that women tolerate pain better than men when estrogen levels are higher, and less well than men when estrogen levels drop–we are still discovering whether it is the rate of drop that is critical (likely), or whether it is also the estrogen:progesterone ratio that has an effect.

Other studies have shown that postmenopausal women process pain similarly to men.

I will say this, though: when I do Botox injections in the office, it’s generally not the women who get faint on me. 😉

Birth Control Pill News

This is all well and good…if you are young, and if you do not have migraine with aura.

Please refer to the following from the ACHE website: Will Using Oral Contraceptives Increase the Risk of Stroke?

It is the standard of care amongst headache experts to advise that women with migraine with aura either not use oral contraceptives at all, or use them very judiciously and with aspirin cardiac prophylaxis, and only if there are no significant cardiovascular risk factors. It is also recommended that women who have migraine without aura discontinue oral contraceptives after age 35. Smokers who have migraine should not use oral contraceptives at all.

I recall reading a recent article that surveyed migraine sufferers, and found that a significant proportion of primary care physicians were not aware of current recommendations regarding migraine and oral contraceptives. (I cannot, however, find the article in my giant stack-of-articles-to-be-filed. So, no citation for you–sorry. I think the author was Dr. Elizabeth Loder, but Google is not bringing it up.)

There is also newer data regarding the increased risk of heart disease in women with migraine, which was published in JAMA recently.

This study looked at women over 45, but estrogens, contained in the vast majority of contraceptives, are also a cardiac risk factor.

So–if you are going to proceed with this, be certain your physician knows you are a migraine sufferer (if you are), and research your family history and personal cardiovascular risk factors.

To learn more about and from Dr. Peterson, visit her websites, Migraine Survival and Headquarters Migraine Management.

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Toxicity of Tylenol

Before I was diagnosed with migraine and CDH, OTC painkillers were my constant companion. It was in the pockets of my jeans, buried in the bottom of my backpack and in little plastic bags strewn about my car. I’d find pills nestled in the carpet and in my bed. You get the point.

Even though my drug of choice was sold OTC, I knew that I shouldn’t take as much as I did as often as I did. But the risks were vague enough for me to ignore them. I’m not nice enough to let you ignore them too.

Get this: Overdoses of products that contain acetaminophen account for 40 to 50% of all acute liver failure cases each year in the United States. A recent study in the University of Michigan Health System showed that about half of these overdoses were the unintentional side effect of treating an ailment, like headaches. The researchers deemed these cases “therapeutic misadventures.” (Isn’t that a perfect description? It conveys the situation so clearly.)

Even if someone is careful to stay within the prescribed daily dosage of Tylenol, there’s a risk of accidentally combining it with any one of a number of other drugs that have acetaminophen as one component of many. More than 150 OTC drugs, from cold treatments to sleep aids to fever reducers, contain acetaminophen. Midrin, a prescription migraine abortive, has acetaminophen in it, as do many other prescription drugs, including painkillers.

You aren’t doomed to liver damage or failure if you take Tylenol. The University of Michigan offers these guidelines to keep yourself safe while taking acetaminophen:

  • Before taking acetaminophen, tell your doctor if you have ever had liver disease or if you drink alcohol daily or on a chronic basis
  • Carefully read the labels on all medications so you are aware of their acetaminophen content (both prescription and OTC)
  • Acetaminophen is found in Tylenol-brand products, some varieties of Excedrin, FeverAll, Genapap, Percocet and more
  • It is included in combination products, such as Midol Teen Menstrual Formula Caplets containing Acetaminophen and Pamabrom
  • Many prescription pain relievers also contain acetaminophen, such as Lorcet Plus, Darvocet and Vicodin
  • In case of an overdose, call your local poison control center at (800) 222-1222
  • Keep medications locked up or out of reach of children.
  • Do not take the full day’s dose of acetaminophen at one time; space it out over the course of the day

All that said, if you are taking enough Tylenol or any OTC painkiller to be worried about liver damage, you’d probably be best off seeing a doctor about your headaches. You could be having rebound headaches or you could be treating yourself for the wrong problem . It can take a lot of time and energy to find a healthcare provider that you like and a course of treatment that’s effective for you, but you’ll feel best in the long run if you make this commitment.

11/4/08: I’ve closed comments on this post because of excessive spam.