Overuse of Acetaminophen Increases During Flu Season

By Pat Anson, Editor

Acetaminophen is a key ingredient in hundreds of over-the-counter pain relievers and cough, cold and flu medicines – from Excedrin and Tylenol to Theraflu and Alka-Seltzer Plus.

Recent guidelines released by the UK’s National Institute for Health Care Excellence (NICE) even recommend acetaminophen (paracetamol) for treating sore throat pain.

But a large new study warns that too many cold and flu sufferers take too much acetaminophen – which has long been associated with liver damage and allergic reactions such as skin rash.

Researchers at the University of Pittsburgh and Boston’s University’s Slone Epidemiology Center surveyed nearly 14,500 U.S. adults about their use of acetaminophen in the preceding 30 days. The study, which was sponsored by Johnson & Johnson, was conducted over a five-year period, from 2011 to 2016.

Investigators found that 6.3% of acetaminophen users exceeded the recommended maximum adult daily dose of 4,000 mg on at least one day during a week that they used acetaminophen.

Usage patterns grew during the cold and flu season. The odds of taking more than 4,000 mg of acetaminophen increased to 6.5% compared to 5.3% during the off-season.

This was primarily due to increased use of over-the-counter medications designed to treat upper respiratory cold and flu symptoms.

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"This is the first multi-year, year-round study that includes detailed data on how consumers used acetaminophen medications," said Saul Shiffman, PhD, of Pinney Associates and the University of Pittsburgh. "The study findings suggest the importance of educating consumers about acetaminophen and counseling them about appropriate use and safe dosages of these medications.

"Getting this message out is especially important during cold/flu season, when people may be more likely to treat illness symptoms with acetaminophen combination products, sometimes without even realizing they contain acetaminophen."

The use of acetaminophen (paracetamol) is even more pronounced in France, according to a new study published in the British Journal of Clinical Pharmacology.

There was a 53% increase in the use of paracetamol in France between 2006 and 2015, and 1000 mg tablets of paracetamol (which are not available in the United States) are now the most-used drug among French adults. There is also a trend towards larger doses. Consumption of 1000 mg tablets increased by 140 percent in France over the ten-year study; while consumption of 500 mg tablets decreased by 20 percent.

Compared to other countries in Europe, France ranked first in paracetamol usage and third in the consumption of mild opioids such as tramadol and codeine. The French use of strong opioids such as morphine was among the lowest in Europe.

"To our knowledge, this is the first published study analysing consumption trends for both non-opioids and opioids over the last decade in France. Long-term surveillance over the past 10 years has highlighted quantitative and qualitative changes in analgesic consumption patterns in France," said study co-author Philippe Cavalié, PhD, of the French National Agency for Medicines and Health Products Safety.

"The very widespread analgesics consumption that we have documented raises the concern of overuse and misuse, as well as addiction to opioids."

The U.S. Food and Drug Administration asked drug makers in 2011 to limit acetaminophen doses to 325 mg per tablet or capsule. The FDA also requires a “Boxed Warning” label – the agency’s strongest warning – to call attention to serious risks.

Over 50 million people in the U.S. use acetaminophen each week for pain and fever – many unaware of the risk of liver injury and allergic reactions. Over 50,000 emergency room visits each year in the U.S. are blamed on acetaminophen overdoses, including 25,000 hospitalizations and 450 deaths.

For more information about acetaminophen and how to avoid overdosing, visit KnowYourDose.org.

FDA: Opioid Cold Meds Too Risky for Kids

By Pat Anson, Editor

The Food and Drug Administration has ordered stronger warning labels for cough and cold medications containing opioids and said they should no longer be prescribed to patients younger than 18. The agency also signaled it that it could enact new limits on the dose and duration of other types of opioid prescriptions.

“Given the epidemic of opioid addiction, we’re concerned about unnecessary exposure to opioids, especially in young children. We know that any exposure to opioid drugs can lead to future addiction,” said FDA Commissioner Scott Gottlieb, MD. “It’s become clear that the use of prescription, opioid-containing medicines to treat cough and cold in children comes with serious risks that don’t justify their use in this vulnerable population.”

The FDA action involves nine different types of cough and cold medicines, four of which contain codeine and five that have hydrocodone. The brand names include Tuxarin ER, Tuzistra XR, Triacin C, FlowTuss and Zutripro. Several of the medications also come in generic form.

The FDA said it conducted an extensive review of the products and convened a panel of pediatric experts, who said the risk of misuse, abuse and addiction outweighed the benefits in patients younger than 18.

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“These products will no longer be indicated for use in children, and their use in this age group is not recommended.  Health care professionals should reassure parents that cough due to a cold or upper respiratory infection is self-limited and generally does not need to be treated.  For those children in whom cough treatment is necessary, alternative medicines are available,” the FDA said in a statement.

The agency also ordered stronger “Black Box” warning labels on opioid cough and cold medicines to make them more consistent with safety warnings that come with opioid pain medications.

‘Too Many People Prescribed Opioids’

The FDA this week also released its 2018 Strategic Policy Roadmap, which outlines four priority areas in the year ahead.

The agency's first goal is to reduce the abuse of opioid medication. The FDA said opioid addiction and overdoses were claiming lives at a “staggering rate” of 91 deaths every day – although it failed to point out that most of those deaths involve illegal opioids such as heroin and illicit fentanyl, not prescription pain medication. Also unmentioned in the “roadmap” is that opioid prescriptions have been declining since 2010.

“Too many people are being inappropriately prescribed opioid drugs. When these prescriptions are written, they are often for long durations of use that create too much opportunity for addiction to develop,” the FDA said.

“We need to take steps to reduce exposure to opioid drugs by helping to make sure that patients are prescribed these drugs only when properly indicated, and that when prescriptions are written, they are for dosages and durations of use that comport closely with the purpose of the prescription.” 

Several states have already enacted limits on opioid prescriptions for acute, short term pain. Minnesota, for example, recently adopted strict new guidelines that limit the initial supply of opioids for acute pain to just three days. 

Flu and NSAIDs Increase Heart Attack Risk

By Pat Anson, Editor

With the cold and flu season in full swing, many people take over-the-counter pain relievers like Advil and Aleve to ease their aches and pains, and to help them sleep.

What many don’t know is that they may be increasing their risk of a heart attack.

In a study of nearly 10,000 people hospitalized in Taiwan after a heart attack, researchers found that patients who took non-steroidal anti-inflammatory drugs (NSAIDs) during an acute respiratory infection tripled their risk of an acute myocardial infarction (heart attack).  The study was published in the Journal of Infectious Diseases.

Respiratory infections and NSAIDs were both already known to raise the risk of cardiovascular problems, but this was the first time they were studied together.  

"Physicians should be aware that the use of NSAIDs during an acute respiratory infection might further increase the risk of a heart attack," said lead author Cheng-Chung Fang, MD, of National Taiwan University Hospital.

“This approach should raise clinical concern because NSAIDs use during ARI (acute respiratory infection) episodes is highly common in real-world practice.”

Fang and his colleagues found that using NSAIDs while having a respiratory infection was associated with a 3.4-fold increased risk for a heart attack. The risk was 7.2 times higher when patients received NSAIDs intravenously in the hospital.

Another commonly used pain reliever, acetaminophen, which eases pain in a different way than NSAIDs do, was not evaluated in the study. But researchers say it may be a safer alternative, at least in terms of cardiac risk, for relief from cold and flu symptoms.

NSAIDs are widely used to treat everything from fever and headache to low back pain and arthritis. They are found in so many different over-the-counter products -- such as ibuprofen, Advil and Motrin -- that many consumers may not be aware how often they use NSAIDs. 

In 2015, the U.S. Food and Drug Administration ordered warning labels for all NSAIDs to be strengthened to indicate they increase the risk of a fatal heart attack or stroke. The revised warning does not apply to aspirin. The FDA said people who have a history of heart disease, particularly those who recently had a heart attack or cardiac bypass surgery, are at the greatest risk.

European researchers released an even stronger warning last year, saying there was no solid evidence that NSAIDs are safe.

Exactly how the pain relievers damage the heart is unclear, but a recent study on animals at the University of California, Davis found that NSAIDs reduced the activity of cardiac cells and caused some cells to die.

Experts Say Weather’s Not to Blame for Your Pain

By Pat Anson, Editor

The age old debate over weather’s impact on pain is heating up again with new research indicating that cold, rainy weather has no impact on symptoms associated with back pain or osteoarthritis.

Researchers at The George Institute for Global Health in Australia say damp weather makes people more aware of their pain, but the symptoms disappear as soon as the sun comes out – suggesting there’s a psychological cause.

“Human beings are very susceptible so it’s easy to see why we might only take note of pain on the days when it’s cold and rainy outside, but discount the days when they have symptoms but the weather is mild and sunny,” said Professor Chris Maher, director of the George Institute’s Musculoskeletal Division.  

“The belief that pain and inclement weather are linked dates back to Roman times. But our research suggests this belief may be based on the fact that people recall events that confirm their pre-existing views.”

Maher and his colleagues conducted two studies involving nearly 1,000 Australians with back pain and 345 people with osteoarthritis.

Using weather data from the Australian Bureau of Meteorology, researchers compared the weather at the time patients first noticed pain with weather conditions one week and one month before the onset of pain as a control measure. 

Results showed no association between back pain and temperature, humidity, air pressure, wind direction or precipitation. Warmer temperatures did slightly increase the chances of lower back pain, but the amount of the increase was not clinically important. 

A previous study on back pain and weather at The George Institute had similar findings, but received widespread criticism from the public.

“People were adamant that adverse weather conditions worsened their symptoms so we decided to go ahead with a new study based on data from new patients with both lower back pain and osteoarthritis. The results though were almost exactly the same – there is absolutely no link between pain and the weather in these conditions,” said Maher.

The back pain study was published in the journal Pain Medicine. The study on osteoarthritis was published in Osteoarthritis and Cartilage.

“People who suffer from either of these conditions should not focus on the weather as it does not have an important influence on your symptoms and it is outside your control,” said Associate Professor Manuela Ferreira.

The Greek philosopher Hippocrates in 400 B.C was one of the first to note that changes in the weather can affect pain levels. Although a large body of folklore has reinforced the belief that there is a link between weather and pain, the science behind it is mixed.

PNN readers say there’s little doubt in their minds that there’s a connection.

“I totally agree that rainy weather does affect pain. I have osteoarthritis and fibromyalgia, and pain is most severe when there is a change happening in the weather especially rain,” wrote Dee.

“It's been well established that the source of weather-related pain is a direct result from the variance in barometric pressure,” said Judith Bohr. “Changes in the intensity of that pressure is felt more acutely in the parts of the body where there are injuries, degenerative changes, surgeries, wherever there is an increased sensitivity because of inflammation.”

Others say they can predict the weather based on their pain levels.

“So many sunny days and I've said it’s going to rain. People thought I was crazy for a while, but now they know,” said Ashley. “My kids are always asking if it’s going to rain.”

A study currently underway in England suggests there is a connection between weather and pain. Over 9,000 people are participating in The University of Manchester’s Cloudy with a Chance of Pain project, using a special app on their smartphones to record their daily pain levels. The app also captures hourly weather conditions.

Preliminary results show that as the number of sunny days increase, the amount of time participants spend in severe pain decreases. When the weather turns rainy and cloudy, however, the amount of time people spent in severe pain increases.