tylenol

11 November 2022

Falling from Favour: Paracetamol / Acetaminophen

James Discoveries & Stats, Information, Medications 0

The story of acetaminophen/paracetamol, commonly associated with the brand name Tylenol, is a strange one. A researcher studying treatments for worms requested one chemical and received the wrong one. The worms didn’t mind it, but it did seem to fight fever.

It was in the late 1800s that acetaminophen was first used to fight fever and pain in Germany. But it was never widely used until it came to market in the USA and the United Kingdom in the 1950s.

As might be expected, a drug to treat pain and/or fever quickly became popular. Not only by itself, but in combination with other medications under numerous brand names. Few medications are taken with as much frequency as this one.

As is the case with many drugs, we’re not really sure how it works. The most common theory today is that it blocks COX (cyclooxygenase) enzymes in the brain, thus keeping pain signals from being transmitted. Read more from Tufts University School of Medicine: How Does Acetaminophen Work?

Being so common, problems started to arise with overdoses. It’s easy to take too much, or to take two products that contain paracetamol without carefully checking the labels. (By the way, unlike some “painkillers”, taking more of this one doesn’t increase its power – so never take more than the recommended amount thinking it will help you more.)

Liver damage, or even liver failure, from paracetamol is very common. Concerned, the FDA changed its recommendations in 2014. (See also How to Protect Your Liver from Acetaminophen) Added to that have come concerns about hypertension.

The European Journal of Pain published an article entitled “A history of errors, failures and false decisions”, calling it “probably one of the most dangerous compounds in medical use”.

When we thought that taking some during pregnancy was one of the safer options, concerns began to emerge regarding the development of the baby – in particular, “neurodevelopmental, reproductive and urogenital disorders”, and that paracetamol “interferes with sex and thyroid hormone function essential for normal brain development”. Also see Acetaminophen / Paracetamol – Not safe during Pregnancy after all? It seems like there have been a lot of assumptions about this medication’s safety, but not as many studies as such a ubiquitous drug deserves.

The “good” news may be that this may not be your best choice for headaches after all. Sure, if it works for the occasional tension-type headache, there may be no reason to change. But if you’re popping a pill every month, or every week, it’s time to talk to your doctor. But when it comes to other headache conditions such as migraine, there are so many better options that you may want to avoid acetaminophen altogether. See Is Acetaminophen/Paracetamol Really “Ineffective”?

Recent studies remind us of some key issues that we’ve talked about before:

Even “safe” medications should be used rarely, if possible. They all have risks.
You are an individual, and you need to find what works for you.
Lifestyle, such as regular movement and what you eat, are still king, and can never be replaced by a pill.
Read labels.
Getting headaches on a regular basis? Talk to a specialist. There are probably better treatments than over-the-counter painkillers.

Paracetamol is a unique drug with a strange history. It has helped many, but as our knowledge continues to expand, we may find that it has had its day. This will be an interesting story to keep watching.

21 April 2021

Is Acetaminophen/Paracetamol Really “Ineffective”?

James Discoveries & Stats, News 0

A recent headline says: “Paracetamol ineffective for most pain conditions“. So what’s the story when it comes to headache?

Is acetaminophen really effective for headache?

Paracetamol, also called acetaminophen, is still often known by the common brand name Tylenol. Along with aspirin and ibuprofen, it has been a well-known go-to when it comes to over-the-counter drugs for pain management.

The study (link below) was actually a review of 36 systematic reviews published in medical journals. In those reviews, 44 pain conditions were treated with acetaminophen/paracetamol.

Now, things start to get complicated once you drill down that far. Researchers had to watch for bias or errors in studies, or studies that weren’t relevant for whatever reason. And sometimes you end up with a small amount of information for certain conditions. But you do end up with a good summary of what we know, even if what we know is somewhat limited in certain cases. Make sense? 🙂

The study was also mainly focused on whether or not there was “immediate” pain relief, although a couple of conditions did focus on ongoing treatment (osteoarthritis pain and rheumatoid arthritis).

The good news for headache sufferers is that Tylenol for tension-type headache actually turned out to be one of the more successful stories – although, not that successful. Only two conditions made it to “high quality” evidence, but tension-type headache was listed under “moderate quality evidence of efficacy”. In other words, there is fair evidence that acetaminophen/paracetamol will provide some pain relief for that headache. Not exactly a miracle-cure, according to these researchers.

But notice that I only mentioned tension-type headache. What other headaches made the list?

Quite a few – but acetaminophen/paracetamol only had “low quality evidence” for these headaches:

Acute Migraine
Cold related headache

There was also low-quality evidence that it wasn’t effective for:

Migraine in children/adolescents

Of course there are many other headache types, but generally the evidence wasn’t available either way.

In the end, this study mostly tells us that surprisingly there are very few good quality studies of acetaminophen for headache conditions, and that most of the studies out there simply aren’t all that impressive, with the possible exception of tension-type headache. For other conditions, pain relief after surgery did not fare well, and the condition that really did not seem to be helped at all was lower back pain.

There was good news for craniotomy – surgeries in which the skull is opened up, and knee or hip osteoarthritis. However, researchers admitted that “the effect sizes were very small”.

The other good news is that the number of adverse effects was small – but again researchers noted that there wasn’t very much research to be sure.

It might surprise us that such a ubiquitous top-selling pain killer has so little research behind it. Of course, it’s a challenge to research a “pain killer” for every individual condition. If it kills pain, doesn’t it just pain?

Apparently not. And that’s another interesting point in this study. How well it works, and even adverse effects, depend very much on the condition.

—-> From what we know, if you take acetaminophen/paracetamol very occasionally for headache, and it works for you, no worries. But if headache is a significant disruption in your life, say every month or every week, you should be talking to a doctor to find better options. If that pain killer you’re using really isn’t making your life that much better, it’s time to realize that there are many more options out there.

To read the study, published in the Medical Journal of Australia, just click here: The efficacy and safety of paracetamol for pain relief: an overview of systematic reviews

10 March 2014

Acetaminophen / Paracetamol – Not safe during Pregnancy after all?

James Discoveries & Stats, Medications, News 0

This wasn’t really the news we wanted to hear. After all that women with headache have to deal with during pregnancy – now there’s doubt about just how safe Tylenol is.

A study published in JAMA Pediatrics in February studied the link between acetaminophen / paracetamol and behaviour problems linked to attention-deficit/hyperactivity disorder (ADHD).

The study used telephone interviews during pregnancy and 6 months after, and then the follow-up 7 years later.

The researchers found that use of acetaminophen / paracetamol did increase the risk of ADHD. They also discovered that if the mother used the drug during more than one trimester, the risk increased. If more Tylenol was taken, the risk also increased.

On one level this is very discouraging news with anyone with chronic headache, who may be taking acetaminophen /paracetamol more than a few times over nine months. It also demonstrates that there may be “subtle” issues that are not studied yet – side effects for the baby that we don’t even yet understand – that this and other drugs may be causing.

Every medication comes with risk. We need to do our best to weigh the risk and benefit. Although many of the risks are simply unknown, in the modern age of powerful computers we can expect to see more risks like these come to light as studies become more sophisticated.

On another level, however, this may not be as big an issue for many mothers. For those with migraine, Tylenol is likely not the best choice anyway, and may be very little help. More complete targeted treatment, including non-drug treatments, can be a great help to pregnant women.

Of course that doesn’t mean we’re getting away from risk – just this risk. But it does mean that there may be treatments that are effective enough that the woman can take fewer drugs, and have less pain during pregnancy.

Dr. Alexander Mauskop has some thoughts on this study and treatment during pregnancy here. Read the abstract on the study at Acetaminophen Use During Pregnancy, Behavioral Problems, and Hyperkinetic Disorders. See also Can Pregnant Migraineurs Take Drugs?

22 January 2014

FDA Attempts to Lower Acetaminophen / Paracetamol Intake

James Medications, News 1

Concerns about liver injury are prompting regulators in the US to encourage lower doses of paracetamol / acetaminophen. In a statement last week, the FDA in the United States suggested that doctors stop prescribing dosages above a certain limit.

FDA - new recommendations for acetaminophen

That limit is 325mg per dosage unit, meaning that in certain cases doctors could prescribe up to 650mg in two tablets or capsules.

Concerns about acetaminophen are not new. An overdose can cause liver damage that could be serious and even fatal.

Although most of the more serious dangers are minimized when following the instructions on the label, there have still been some issues:

When a patient takes paracetamol / acetaminophen in more than one product at the same time, such as in a “pain killer” and a “cold medication”.
When a patient takes Tylenol and alcohol at the same time.
When patients end up taking painkillers every other day or even more.

Although the new FDA recommendations don’t solve all these problems, they do help doctors, pharmacists, and patients take a second look at exactly what they are prescribing, dispensing and taking.

Remember, read the label, talk to your doctor, and remember that taking medications (even “mild” ones) is something to take seriously.

Read the full recommendation from the FDA here: Acetaminophen Prescription Combination Drug Products with more than 325 mg: FDA Statement – Recommendation to Discontinue Prescribing and Dispensing

2 December 2011

Too Much Tylenol – Over Time?

James Discoveries & Stats, Medications 1

Hopefully most people are aware of the dangers of taking too much paracetamol / acetaminophen. Sometimes people are taking different products that both contain acetaminophen – and inadvertently take too much. It can be very dangerous.

But what about a "staggered overdose"? That is, people who are taking a little too much over a period of time – could they be just as bad off, or even worse off?

Yes, say researchers – a little-by-little overdose could be even more serious than a one time large overdose – and it could be just as life-threatening.

Researchers at Edinburgh University studied the cases of 161 patients who had come to the hospital there over a 16 year period. They also looked at cases of 663 patients with paracetamol/acetaminophen overdose. Those with the gradual overdose were more likely to develop liver and brain problems, need kidney dialysis, or help breathing. The overdoses were also more likely to be fatal.

To make matters worse, the blood test that would identify a one-time overdose will not identify the staggered overdose. Meaning that it will be easy for your doctor to miss.

The message is clear – follow the instructions on the label, check the ingredients of medications you’re taking, and if you need more pain relief, see a doctor. Just taking "a little more" of something to see if it relieves the pain is not the answer.