Pregnant Women Raise Risk of Complications by Using OTC Pain Relievers

By Pat Anson, PNN Editor

Pregnant women who take over-the-counter pain relievers are one-and-a-half times more likely to have complications, including stillbirth and premature delivery, according to a large new study.

Researchers at the University of Aberdeen analyzed data from over 151,000 pregnancies in the UK from 1985-2015, looking for medical notes indicating the women used paracetamol (acetaminophen), aspirin or the non-steroidal anti-inflammatory drugs (NSAIDs) diclofenac, naproxen and ibuprofen — either alone or in combinations.

The findings, recently published in BMJ Open, show a significantly higher risk of a preterm delivery, neonatal death, low birth weight and other health problems in babies born to mothers who used OTC pain relievers. Neural tube defects of the brain, spine or spinal cord were 64% more likely; while hypospadias, a birth defect affecting the penis, was 27% more likely.

“Over-the-counter analgesics consumption during pregnancy was associated with a substantially higher risk for adverse perinatal health outcomes in the offspring. The use of paracetamol in combination with other non-steroidal anti-inflammatory drugs conferred the highest risk,” wrote lead author Aikaterini Zafeiri, PhD. “The increased risks of adverse neonatal outcomes associated with non-prescribed, over-the-counter, analgesics use during pregnancy indicate that healthcare guidance for pregnant women regarding analgesic use need urgent updating.”

One of the more surprising aspects of the study is how use of the five analgesics by pregnant women grew dramatically over the 30-year study period.  In 1985, only 1.8% reported using one of the pain relievers. By 2015, that had grown to 70.6% -- with most of the increase coming in the last seven years of the study.

Although it is believed to be one of the largest and most comprehensive studies of its kind, the research was limited. The duration, dose and stage of the pregnancy when analgesics were consumed were not recorded. The health of the mothers and babies later in life was also not studied.

But given the substantial increase in analgesic use during pregnancy and the higher risk of complications, researchers say more caution is needed on use of the drugs.

“The ease of access to non-prescription painkillers, in combination with availability of misinformation as well as correct information through the internet, raises safety concerns,” said Zafeiri. “It should be reinforced that paracetamol in combination with NSAIDs is associated with a higher risk and pregnant women should always consult their doctor or midwife before taking any over-the-counter drugs. We would encourage a strong reinforcement of the official advice for pregnant women.”   

Previous studies have linked prenatal use of paracetamol to autism, hyperactivity and behavioral problem in children. Despite the findings, drug regulators in the UK and US maintain that it is safe for pregnant women to use paracetamol (acetaminophen).

“Paracetamol is the first choice of painkiller if you're pregnant or breastfeeding. It's been taken by many pregnant and breastfeeding women with no harmful effects in the mother or baby,” the UK’s National Health Service (NHS) says on its website.

The Food and Drug Administration also does not caution pregnant women about using acetaminophen. The agency said in 2015 that the evidence was “too limited” to justify such a warning.  

Meanwhile, drug regulators in Australia are so concerned about recent deaths involving paracetamol that they may restrict access to the drug. Australia’s Therapeutic Goods Administration (TGA) has commissioned a report by an expert panel on the risks of paracetamol misuse.

“While paracetamol has well established safety and toxicity profiles, the wide use is paralleled by a high prevalence of accidental and deliberate paracetamol poisoning in the community, in both adults and children,” the TGA said in a statement earlier this month.

“The TGA is aware of concerns, particularly of families and healthcare professionals of affected consumers of paracetamol, regarding the number of poisonings and deliberate overdoses from paracetamol obtained from general retail outlets, and whether current access restrictions are appropriate.”

Australia currently regulates the quantity and dose of paracetamol sold over-the-counter. The independent commission will consider if stricter buying limits should be imposed. 

Fizzy Pain Relievers Are Bad for the Heart

By Pat Anson PNN Editor

Long-term use of the pain reliever acetaminophen has long been associated with liver, kidney, heart and blood pressure problems.  A new study has also found that some acetaminophen tablets are so loaded with salt that they significantly raise the risk of a heart attack or stroke in as little as one year.

At issue are dissolvable acetaminophen tablets that are mostly used to treat cold and flu symptoms, as well as minor aches and pains. The tablets quickly dissolve in water because of their high salt (sodium) content, creating a fizzy, effervescent drink that is absorbed more quickly in the digestive system than a standard tablet.

Some of the fizzy tablets contain as much as 440 milligrams of sodium per pill. A recommended daily dose of two tablets taken four times a day adds up to over 3,500 milligrams – more sodium than three McDonald’s Big Macs – and nearly double the daily amount recommended for healthy adults.

Since high salt content has long been associated with cardiovascular problems, a team of researchers looked at the health records of 300,000 people enrolled in Britain’s National Health Service who were prescribed acetaminophen (paracetamol) to see what impact the medications may have.

Their findings, recently published in the European Heart Journal, showed that patients with a history of high blood pressure (hypertension) taking fizzy acetaminophen tablets were up to 45% more likely to suffer a heart attack, stroke or heart failure within a year. Just one prescription for the tablets increased their risk of dying by 177 percent, and those with five or more prescriptions were 264% more likely to die.

The risk of a heart attack, stroke or death for patients without high blood pressure also rose with a prescription for fizzy acetaminophen, but to a lesser degree.

“The direct message from this study is clear—there are likely to be millions of people worldwide taking paracetamol on a daily basis in a ‘fast-acting’ effervescent or soluble formulation who are increasing their risks of cardiovascular disease and premature death,” wrote Aletta Schutte, PhD, and Bruce Neal, PhD, in an accompanying editorial.

“Fortunately, only a small proportion of paracetamol formulations contain sodium but, with ‘fast-acting’ and ‘fizzy’ medications increasing in popularity, the adverse effects of medication-related sodium intake look set to rise rather than fall.”

The risk isn’t limited to fizzy tablets with acetaminophen. Other effervescent medications containing aspirin, ibuprofen and even vitamins also contain high levels of sodium.  

With or without salt, long-term acetaminophen use can be risky. A recent study at the University of Edinburgh found that acetaminophen significantly raised the risk of heart disease and stroke in people with high blood pressure. Researchers said the increased risk of cardiovascular problems was similar to that seen with non-steroidal anti-inflammatory drugs (NSAIDs).

Acetaminophen is the most widely used over-the-counter pain reliever in the world — and is the active ingredient in Tylenol, Excedrin, and hundreds of pain medications. But a 2021 review found little or no evidence to support the use acetaminophen for most pain conditions.

Acetaminophen Use by Pregnant Women Raises Risk of Autism or ADHD in Children

By Pat Anson, PNN Editor 

A large new study in Europe is adding to the growing body of evidence that the use acetaminophen (paracetamol) by pregnant women raises the risk of their children having autism or Attention-Deficit Hyperactivity Disorder (ADHD)

Researchers at the University of Barcelona followed nearly 74,000 mothers and their children in the UK and five other European countries, finding that women who took the pain reliever while pregnant were 19% more likely to have children with Autism Spectrum Conditions (ASC) and 21% more likely to develop ADHD symptoms.

“Associations between prenatal acetaminophen and ASC and ADHD symptoms were consistently positive for both boys and girls albeit slightly stronger among boys,” researchers reported in the European Journal of Epidemiology.

Several previous studies have linked prenatal use of acetaminophen to autism, ADHD and hyperactivity in children, but this was by far the largest. Although the exact cause is unknown, it’s believed acetaminophen affects a baby’s brain development and growth, especially during the third trimester. The study found no evidence that acetaminophen raised the risk of autism and ADHD after the children were born.

Despite the findings, the UK’s National Health Service (NHS) maintains that it is safe for pregnant women to use paracetamol.

“Paracetamol is the first choice of painkiller if you're pregnant or breastfeeding. It's been taken by many pregnant and breastfeeding women with no harmful effects in the mother or baby,” the NHS says on its website.

The U.S. Food and Drug Administration also does not caution pregnant women about using acetaminophen. The agency said in 2015 that the evidence was “too limited” to justify such a warning.  

The University of Barcelona researchers are a bit more cautious, saying pregnant women should take acetaminophen “only when necessary.”

“Considering all evidences on acetaminophen use and neurodevelopment, we agree with previous recommendations indicating that while acetaminophen should not be suppressed in pregnant women or children, it should be used only when necessary,” they said.

Acetaminophen is the most popular pain reliever in the world, and is used by over half the pregnant women in Europe and the United States. It is the active ingredient in Tylenol, Excedrin, and hundreds of pain medications. Excessive use of acetaminophen can cause liver, kidney, heart and blood pressure problems. A recent study found little or no evidence to support its use for most pain conditions.  

Study Finds Little Evidence to Support Use of Acetaminophen

By Pat Anson, PNN Editor

Acetaminophen is the most widely used over-the-counter pain reliever in the world — the active ingredient in Tylenol, Excedrin, and hundreds of pain medications. The U.S. Centers for Disease Control and Prevention considers acetaminophen a “first-line” treatment for low back pain, osteoarthritis and migraine.

But a comprehensive review published in the Medical Journal of Australia found little or no evidence to support the use acetaminophen for most pain conditions. Researchers at the University of Sydney analyzed 36 studies involving over 19,000 people and concluded that the pain-relieving benefits of acetaminophen – known as paracetamol outside the U.S. -- are modest, at best.

“For most conditions, evidence regarding the effectiveness of paracetamol is insufficient for drawing firm conclusions. Evidence for its efficacy in four conditions was moderate to strong, and there is strong evidence that paracetamol is not effective for reducing acute low back pain,” wrote senior author Christopher Maher, PhD, a professor at the Sydney School of Public Health.

Maher and his colleagues looked at 44 pain conditions often treated with paracetamol, and could find only four for which there is high-quality evidence:

• Knee and hip osteoarthritis

• Tension headache

• Perineal pain after childbirth

• Craniotomy

Evidence for the other 40 pain conditions was low quality or inconclusive, including:

• Acute and chronic low back pain

• Major surgery

• Dental surgery

• Migraine

• Rheumatoid arthritis

• Hip fracture

• Cancer pain

• Neuropathic pain

“While paracetamol is widely used, its efficacy in relieving pain has been established for only a handful of conditions, and its benefits are often modest. Although some trials have evaluated regimens that may have underestimated its utility, the clinical application of paracetamol is primarily guided by low quality evidence, at best,” researchers said.  

A 2015 study in the British Medical Journal also found that paracetamol was ineffective for low back pain and provided little benefit to people with osteoarthritis.

In recent years, some U.S. hospitals have started using paracetamol as an alternative to opioids for post-operative pain, a practice not supported by the Australian study.

One limitation of the University of Sydney review is that most of the studies that were evaluated only used a single dose of paracetamol, which does not reflect its typical use.  Perhaps for that reason, researchers found that adverse events were similar for patients receiving paracetamol or a placebo.

Over 50 million Americans use paracetamol (acetaminophen) each week to treat pain and fever. Long-term use has long been associated with liver, kidney, heart and blood pressure problems. Acetaminophen overdoses are involved in about 500 deaths and over 50,000 emergency room visits in the U.S. annually.

Acetaminophen Better Than NSAIDs for Acute Trauma Pain

By Pat Anson, PNN Editor

Acetaminophen (Tylenol) is superior to non-steroidal anti-inflammatory drugs (NSAIDs) in treating acute pain in patients recovering from arm and leg trauma, according to new research published in the journal Academic Emergency Medicine. It’s the latest in a string of studies that recommend the use of non-opioid pain relievers for acute pain after discharge from a hospital.

The research is based on a study of 1,500 adults in the North African nation of Tunisia, nearly half of whom had bone fractures. Upon discharge from a hospital emergency department, the patients received either acetaminophen, a high-dose NSAID, or a combination of the two. Acetaminophen is commonly called paracetamol outside the United States.

After seven days, researchers found that nearly two-thirds (61.8%) of patients receiving paracetamol alone were “satisfied” or “very satisfied” with their pain relief. Only 11.4% required another oral pain reliever. The other two groups had similar satisfaction scores, but had lower rates of medication adherence. Side-effects such as vomiting and gastrointestinal pain were also more common in patients who received NSAIDs.  

“This study found that the combination of a high‐dose NSAID with paracetamol does not increase the analgesic effect compared to paracetamol alone. We also found that paracetamol alone is superior to high‐dose NSAID alone for post-traumatic extremity pain,” wrote lead author Mohamed Amine Msolli, MD, an emergency room physician at Fattouma Bourguiba University Hospital in Tunisia.

“Taking into account its superior efficacy and tolerability, paracetamol appears to be the most suitable first‐line therapy for managing mild to moderate posttraumatic extremity pain after discharge from the ED.”

Opioid analgesics are not widely available in Tunisia and most other Middle East countries, and were not included in the study. Nevertheless, the study findings are being cited as evidence that paracetamol is superior to both NSAIDs and opioids in treating acute trauma pain.

“The surprising efficacy of paracetamol over an NSAID, as shown by a 6.4% lower need for additional oral analgesics, may impact prescribing practices,” Andrew Chang, MD, a professor of emergency medicine at Albany Medical Center, said in a statement.

“Many ED patients who have a contraindication to NSAIDs but require analgesics upon ED discharge might be prescribed an opioid. Given the ongoing opioid epidemic, this study lends evidence to support the use of acetaminophen alone in such patients."

But the risk of long-term opioid use after an emergency room visit is actually quite low. A large 2017 study by the Mayo Clinic found that only about one percent of emergency room patients given an opioid prescription progressed to long term use.

Acetaminophen also has risks that are not acknowledged in the Tunisia study. Excessive use of acetaminophen can lead to liver, kidney, heart and blood pressure problems. Acetaminophen overdoses are involved in about 500 deaths and over 50,000 emergency room visits in the U.S. annually.

Study Finds Acetaminophen Makes People More Likely to Take Risks

By Pat Anson, PNN Editor

We’ve learned some weird things about acetaminophen in recent years. The pain reliever not only helps treat headaches and fevers; it also appears to dull human emotions and have other psychological effects.

A new study at The Ohio State University suggests that acetaminophen could even make you more likely to go sky diving or bungee jumping off a tall bridge.

"Acetaminophen seems to make people feel less negative emotion when they consider risky activities - they just don't feel as scared," says co-author Baldwin Way, PhD, an associate professor of psychology at OSU.

Way and his colleagues enrolled 189 college students in the study, giving them either 1,000 mg of acetaminophen (the recommended dose for a headache) or a placebo that looked the same. Participants were then asked to rate on a scale of 1 to 7 how risky they thought various activities would be.

Students who took acetaminophen were more likely to rate bungee jumping, taking a skydiving class, and walking home late at night in an unsafe part of town as less risky than those who took the placebo. They were also less likely to view speaking up about an unpopular issue at work and playing in a high-stakes poker game as risky.

In short, the study found that acetaminophen makes people more likely to take risks, which is not inconsequential when you consider that about 50 million Americans take acetaminophen every week. The pain reliever is the active ingredient in Tylenol, Excedrin and hundreds of other pain medications, as well as cough, cold and flu remedies.

The OSU study, published in the journal Social Cognitive and Affective Neuroscience, was funded by a $500,000 grant from the National Science Foundation, a federal agency. It adds to a growing body of research that found acetaminophen and other over-the-counter pain relievers have psychological effects on humans.

“With nearly 25 percent of the population in the U.S. taking acetaminophen each week, reduced risk perceptions and increased risk-taking could have important effects on society,” said Way. "We really need more research on the effects of acetaminophen and other over-the-counter drugs on the choices and risks we take.”

Burst Balloons

To test their theory, OSU researchers conducted an experiment to see if volunteers would take more risks while inflating a virtual balloon on a computer screen. Participants clicked a button on a computer to inflate the balloon, earning virtual money as a reward each time they did.

"As you're pumping the balloon, it is getting bigger and bigger on your computer screen, and you're earning more money with each pump," Way explained. "But as it gets bigger you have this decision to make: Should I keep pumping and see if I can make more money, knowing that if it bursts, I lose the money I had made with that balloon?"

People who took acetaminophen were more likely to keep on pumping and had more burst balloons.

"If you're risk-averse, you may pump a few times and then decide to cash out because you don't want the balloon to burst and lose your money," said Way. "But for those who are on acetaminophen, as the balloon gets bigger, we believe they have less anxiety and less negative emotion about how big the balloon is getting and the possibility of it bursting."

Previous research at OSU found that acetaminophen seems to dampen human emotions. Student volunteers who took acetaminophen had fewer emotional highs and lows, and felt less empathy for the physical and emotional pain of others. Other studies have linked acetaminophen to hyperactivity and behavior problems in children.

It’s not just acetaminophen. A 2018 review of studies found that ibuprofen and other over-the-counter pain relievers can also dull your emotions and cognitive senses.

A recent study of calls to U.S. poison control centers found a significant increase in suicide calls involving acetaminophen, ibuprofen and other OTC analgesics.

Excessive use of acetaminophen -- also known as paracetamol – can lead to liver, kidney, heart and blood pressure problems. Acetaminophen overdoses are involved in about 500 deaths and over 50,000 emergency room visits in the U.S. annually.

Researchers Developing Safer Version of Acetaminophen

By Pat Anson, PNN Editor

Researchers at Louisiana State University have created a new type of analgesic that is similar to acetaminophen but can relieve pain and reduce fever without the risk of liver or kidney damage.

Acetaminophen -- also known as paracetamol – is the world’s most widely used over-the-counter pain reliever. Over 50 million Americans take acetaminophen each week, many unaware that excessive use can cause liver, kidney, heart and blood pressure problems. Acetaminophen overdoses are involved in about 500 deaths and over 50,000 emergency room visits in the U.S. annually.

Researchers at LSU Health New Orleans created 21 chemical compounds that are structurally similar to acetaminophen, but did not cause liver or kidney toxicity in tests on laboratory rodents. Their findings are published online in the European Journal of Medicinal Chemistry.

"The new chemical entities reduced pain in two in models without the liver and kidney toxicity associated with current over-the-counter analgesics that are commonly used to treat pain -- acetaminophen and NSAIDs. They also reduced fever in a pyretic model,” said senior author Nicolas Bazan, MD, Director of the LSU Health New Orleans Neuroscience Center of Excellence.   

The intellectual property behind the acetaminophen analogs has been licensed to South Rampart Pharma. The company expects to file an investigational new drug application with the Food and Drug Administration in the third quarter 2020, which would pave the way for clinical studies.

"Our primary goal is to develop and commercialize new alternative pain medications that lack abuse potential and have fewer associated safety concerns than current treatment options,” said Bazan. "Given the widespread use of acetaminophen, the risk of hepatotoxicity with overuse, and the ongoing opioid epidemic, these new chemical entities represent novel, non-narcotic analgesics that exclude hepatotoxicity, for which development may lead to safer treatment of acute and chronic pain and fever.”

Bazan said the development of safer pain relievers and fever reducers is particularly important because of the COVID-19 pandemic. Current treatments have led to kidney and liver disease in critically ill SARS-CoV-2 patients.

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. It’s also used in opioid pain medications such as Vicodin. Nearly two-thirds of the world’s supply of acetaminophen comes from China.

Coronavirus Outbreak Raising Fear of Drug Shortages

By Pat Anson, PNN Editor

As the coronavirus spreads around the world, so are fears about drug supply shortages. While the prescription or over-the-counter medication you take may not come directly from China – the epicenter of the outbreak – chances are one of its ingredients does.

According to a recent study, nearly two-thirds of the world’s supply of acetaminophen comes from China. Known as paracetamol outside the United States, 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. It’s also used in opioid pain medications such as Vicodin.

While there’s no sign yet of an acetaminophen shortage, quarantines, travel restrictions and supply disruptions in China caused by the COVID-19 virus are causing some concern.

“One of the ugly secrets of the pharmaceutical industry is that the vast majority of raw materials that go into a prescription drug are produced overseas, mostly in China and India,” Geoffrey Joyce, PhD, chair of the Department of Pharmaceutical and Health Economics at the USC School of Pharmacy told the Los Angeles Times. “The coronavirus shutting down China or India for an extended period of time is likely to have a substantial impact on the supply of many drugs.”

Another academic expert made an even more alarming prediction.

“You’re going to see shortages,” William Comanor, PhD, a professor of health policy and economics at UCLA told The Times. “Tell your readers to stock up on generics!”

Vague Warning from FDA

There is already a shortage of at least one drug, although the head of the Food and Drug Administration didn’t identify what it was in an unusually vague statement released last night.

“A manufacturer has alerted us to a shortage of a human drug that was recently added to the drug shortages list. The manufacturer just notified us that this shortage is related to a site affected by coronavirus. The shortage is due to an issue with manufacturing of an active pharmaceutical ingredient used in the drug,” said FDA Commissioner Stephen Hahn, MD.

“It is important to note that there are other alternatives that can be used by patients. We are working with the manufacturer as well as other manufacturers to mitigate the shortage. We will do everything possible to mitigate the shortage.”

The FDA has contacted over 180 drug manufacturers around the world to remind them they have a legal obligation to notify the agency of any supply disruptions. About 20 pharmaceutical drugs that the FDA calls “non-critical” either come directly from China or have ingredients that come from there.

“We have been in contact with those firms to assess whether they face any drug shortage risks due to the outbreak. None of these firms have reported any shortage to date,” Hahn said.

The FDA is taking Chinese drug manufacturers at their word. Because of federal travel restrictions, FDA inspectors are not currently traveling to China to see for themselves.

Hahn’s statement also warned about manufacturing problems at dozens of Chinese facilities that make “essential” medical devices – but again without identifying what those devices are.

“We are aware that several of these facilities in China are adversely affected by COVID-19, citing workforce challenges, including the necessary quarantine of workers. While the FDA continues to assess whether manufacturing disruptions will affect overall market availability of these products, there are currently no reported shortages for these types of medical devices within the U.S. market,” said Hahn.

Face Mask Shortages

As for personal protective equipment --- such as face masks, gloves and surgical gowns – Hahn said the FDA has “heard reports of increased market demand and supply challenges” but was unaware of widespread shortages. China makes about half of the world’s supply of surgical masks but has stopped virtually all exports.

“Before the outbreak of the epidemic, we used to export 600,000-700,000 surgical masks a month, but now the amount is zero," David Peng, manager of a Chinese medical supplier, told the Chicago Tribune.

Walgreens, Home Depot, Lowe’s and other retailers in the U.S. are scrambling to meet demand for masks or have sold out.

The CDC has been urging healthy people not to use masks and other protective gear because they want those products available at healthcare facilities if the coronavirus outbreak becomes severe. Regular hand washing is the preferred alternative.

“CDC does not recommend that people who are well wear a facemask to protect themselves from respiratory illnesses, including COVID-19. You should only wear a mask if a healthcare professional recommends it,” the CDC says.

“A facemask should be used by people who have COVID-19 and are showing symptoms. This is to protect others from the risk of getting infected. The use of facemasks also is crucial for health workers and other people who are taking care of someone infected with COVID-19 in close settings (at home or in a health care facility).”

Who is most at risk of coronavirus? Unfortunately, its people who are already sick and have compromised immune systems, as Dr. Lynn Webster explained in a recent column.

“The people with increased risk for experiencing severe symptoms, and possibly dying of COVID-19, are seniors and those with chronic illness. Of course, many people in chronic pain are part of both risk groups. The mortality rate of COVID-19 has been reported to be about two percent,” Webster said. “People with chronic pain may be more susceptible to viruses in general, because chronic pain can change the way our immune systems work.”

For more information from CDC on the coronavirus outbreak, including symptoms, prevention and answers to frequentely asked questions, click here.

Study Finds Acetaminophen Eases Social Pain

By Pat Anson, PNN Editor

Most everyone has faced rejection at some point in their lives, such as a divorce, losing a job or being “ghosted” by a friend. Being excluded from a relationship often triggers stress, anxiety, depression and sometimes even a desire for revenge.

Taking the pain reliever acetaminophen ­may not be a prescription for curing the blues, but it can ease social pain and help you forgive others, according to an unusual study published recently in the Annals of Behavioral Medicine. The study adds to a growing body of research that suggests over-the-counter pain relievers have psychological effects on humans.

Researchers in California enrolled 42 healthy young adults in a placebo-controlled trial to see if taking acetaminophen has an effect on social pain.

“Research has shown that physical pain and social pain are influenced by some of the same biological processes in the brain and body. Based on this research, we thought that acetaminophen, which is commonly used to treat physical pain, might also be able to reduce social pain,” explained senior author George Slavich, PhD, director of the UCLA Laboratory for Stress Assessment and Research.

For 20 consecutive days, a third of the study participants took 1,000mg of acetaminophen daily, while the rest took a placebo pill or no pill at all.

Participants also completed a daily questionnaire that assessed their level of social pain by asking them to think about a person who had wronged them recently. Did they I hope that person “gets what’s coming to them” for what they did?

From their answers, researchers developed a numerical “Hurt Feelings Scale” for every participant.

Over time, researchers found that acetaminophen significantly reduced hurt feelings, but only for participants who had a more forgiving attitude towards others.

“When combined with a tendency to forgive, taking acetaminophen substantially reduced how much social pain people felt over time. More specifically, participants taking acetaminophen who were high in forgiveness exhibited an 18.5% reduction in social pain,” said Slavich. “Based on the findings from our study, it appears as though acetaminophen acts synergistically with peoples' ability to forgive to alleviate the feelings of social pain that are commonly associated with rejection and exclusion.”

Slavich and his colleagues say anger and sadness are normal responses to social rejection, but can lead to long-term health consequences if they persist. However, the researchers stopped short of recommending acetaminophen as a treatment for social pain.  

“Experiencing a socially painful life event, like a relationship break-up, is one of the strongest predictors of developing depression in adolescence and adulthood. Social pain is also associated with decreased cognitive functioning and increased aggression and engagement in self-defeating behaviors, like excessive risk taking and procrastination,” Slavich said.

“Although the idea of prescribing acetaminophen to individuals undergoing difficult interpersonal situations may be attractive, we are not aware of any studies that have shown acetaminophen to be an effective prophylactic against psychiatric disorders for persons currently experiencing socially stressful circumstances.”

Similar Findings in Other Studies

A 2015 Ohio State study also found that acetaminophen seems to dampen human emotions. Student volunteers who took acetaminophen had fewer emotional highs and lows, and were less likely to react to images that normally produce an emotional response, such as pictures of a child crying or happily playing with a cat.

A second study at Ohio State found that acetaminophen can make people feel less empathy for the physical and emotional pain of others.

It’s not just acetaminophen. A review of studies at UC Santa Barbara concluded that ibuprofen and other over-the-counter pain relievers have an overlapping effect on us, both physically and emotionally.

"In many ways, the reviewed findings are alarming," wrote lead author Kyle Ratner, PhD, an assistant professor of psychology at UC Santa Barbara. "Consumers assume that when they take an over-the-counter pain medication, it will relieve their physical symptoms, but they do not anticipate broader psychological effects.”

Acetaminophen -- also known as paracetamol – is the world’s most widely used over-the-counter pain reliever. It is the active ingredient in Tylenol, Excedrin, and hundreds of other pain medications. Over 50 million people in the U.S. use acetaminophen each week to treat pain and fever. The pain reliever has long been associated with liver injury, as well as heart, kidney and blood pressure problems.

Acetaminophen Linked to Hyperactivity and Behavior Problems in Children

By Pat Anson, PNN Editor

A new study is adding to the growing body of evidence linking maternal use of acetaminophen to hyperactivity and other behavioral problems in children. Acetaminophen – which is more commonly known as paracetamol outside the U.S. – is the world’s most widely used over-the-counter pain reliever.

British researchers have been following over 14,000 children born in 1991 and 1992 who are enrolled in the Avon Longitudinal Study of Parents and Children. The children’s health, cognitive skills, temperament and behavior were regularly evaluated as they grew older.

Children with mothers who regularly used acetaminophen in mid to late pregnancy were more likely to be hyperactive, less adaptable and to have conduct problems in their pre-school years. The attention and hyperactivity issues appear to lessen by age 7, although boys exposed to the drug were more likely to have conduct problems until age 9.

“We have shown that paracetamol consumption between 18 and 32 weeks gestation was associated with adverse trends in pre‐school child behaviour, but the associations were no longer present by the end of primary school (age 10‐11 years). Boys appeared to be more susceptible than girls to possible behavioural effects of the drug,” researchers reported in the journal Paediatric and Perinatal Health.

Acetaminophen is used by over half the pregnant women in the United States and European Union. It is the active ingredient in Tylenol, Excedrin, and hundreds of pain medications.

Previous studies have linked maternal use of acetaminophen to asthma, autism and attention deficit disorder (ADHD) in children, as well as early puberty and slow language development in girls.

“Our findings add to a series of results concerning evidence of the possible adverse effects of taking paracetamol during pregnancy such as issues with asthma or behaviour in the offspring,” said lead author Professor Jean Golding of the University of Bristol.

“It reinforces the advice that women should be cautious when taking medication during pregnancy and to seek medical advice where necessary.”

Despite the findings, the UK’s National Health Service (NHS) maintains that it is “usually safe” for pregnant women to use paracetamol.

“Paracetamol has been used routinely during all stages of pregnancy to reduce a high temperature and for pain relief. There's no clear evidence it has any harmful effects on an unborn baby,” the NHS says on its website.

The FDA’s warning label for acetaminophen cautions people about the risk of liver damage and other side effects, but does not specifically warn pregnant women about using the pain reliever. The agency said in 2015 that the evidence was “too limited” to justify such a warning.  

Prenatal Use of Acetaminophen Linked to Early Puberty

By Pat Anson, PNN Editor

The daughters of women who took acetaminophen during pregnancy tend to start puberty early, according to a new study by Danish researchers.  

The study is the latest indication that prenatal use of acetaminophen – more commonly known as paracetamol outside the U.S. -- can have long term effects on children.

Researchers at Aarhus University studied health data on about 100,000 Danish women who provided detailed information about their use of acetaminophen during pregnancy.

Nearly 16,000 children born to those mothers between 2000 and 2003 were followed from the age of eleven and throughout puberty, with surveys every six months about different aspects of their development.

The study, published in the American Journal of Epidemiology, found that girls on average entered puberty between one-and-a-half and three months earlier if their mothers took the over-the-counter pain reliever for more than 12 weeks during pregnancy.

"We found a 'dose-response' correlation. That is to say, the more weeks with paracetamol during pregnancy, the earlier puberty in girls, but not in boys," says lead author Andreas Ernst, a PhD student from the Department of Public Health at Aarhus University.

"While entering puberty one-and-a-half to three months earlier may seem unimportant, when taken together with the frequent use of paracetamol during pregnancy, our findings ought to make people take notice. Our results are certainly not the decisive factor that should change current practice, but the perception of paracetamol as 'the safe and harmless choice' during pregnancy ought to be challenged."

Early puberty development increases the risk of serious diseases in adulthood, such as obesity, diabetes, cardiovascular diseases and testicular and breast cancer.

The use of acetaminophen (paracetamol) has been increasing worldwide and studies have found that over half of pregnant women in the U.S. and European Union use the pain reliever at least once during their pregnancy. It is the active ingredient in Tylenol, Excedrin, and hundreds of pain medications.

Previous research has shown that prenatal use of acetaminophen is associated with slow language development, autism and attention deficit problems in young children.

Over 50 million people in the U.S. use acetaminophen each week to treat pain and fever. The pain reliever has long been associated with liver injury and allergic reactions such as skin rash. The FDA label for products containing acetaminophen warns about the risk of liver damage and other side effects but does not specifically warn pregnant women about using the pain reliever. The agency said in 2015 that the evidence was “too limited” to justify such a warning.  

In its 2016 opioid prescribing guidelines, the CDC recommends acetaminophen as an alternative to opioid pain medication. The guideline only briefly mentions that acetaminophen is involved in hundreds of overdose deaths annually and can cause liver problems.

The CDC guideline does warn pregnant women -- at length -- that opioids can cause birth defects, poor fetal growth, still births and neonatal opioid withdrawal syndrome.

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.

"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.

Do OTC Pain Relievers Dull Your Emotions?

By Pat Anson, Editor

Ibuprofen, acetaminophen and other over-the-counter pain relievers may do more than just dull your physical pain. They could also dull your emotional and cognitive senses, according to a new study.

Researchers at the University of California, Santa Barbara reviewed a small body of clinical studies that suggest OTC pain medications have an overlapping effect on us, both physically and emotionally.

One study, for example, found that acetaminophen makes people feel less empathy for others.

Research also found that women who took ibuprofen reported less social anxiety and hurt feelings after being excluded from a game or when writing about a time when they felt betrayed.

Yet another study found that acetaminophen lessens the discomfort of parting with a prized possession. When asked to set a selling price on an object they owned, individuals who took acetaminophen set prices that were cheaper than the prices set by individuals who took placebos.

"In many ways, the reviewed findings are alarming," wrote lead author Kyle Ratner, PhD, an assistant professor of psychology at UC Santa Barbara. "Consumers assume that when they take an over-the-counter pain medication, it will relieve their physical symptoms, but they do not anticipate broader psychological effects.

“Are more regulations needed? Should warnings be expanded on drug labels? At this point, drawing strong conclusions from the existing studies would be premature. Nonetheless, policymakers might start thinking about potential public health risks and benefits.”

Ratner and his colleagues say one place to start is to further study the effects of OTC analgesics on pregnant women. Recent research has found higher rates of autism and attention deficit disorder (ADHD) in young children whose mothers used acetaminophen while pregnant.

Acetaminophen -- also known as paracetamol – is the world’s most widely used over-the-counter pain reliever. It is the active ingredient in Tylenol, Excedrin, and hundreds of other pain medications. Ibuprofen is also widely used and can be found in brand name products such as Motrin and Advil.   

“Found in medicine cabinets across the world and used multiple times per week by people of all ages, genders, and ethnic backgrounds, these drugs are woven into modern life. Policymakers should take note of existing findings but not rush to judgment,” said Ratner.

The study is published online in the journal Policy Insights from the Behavioral and Brain Sciences.

Pain Relievers Linked to Hearing Loss in Women

By Pat Anson, Editor

Long-term use of acetaminophen and ibuprofen raises the risk of hearing loss in older women, according to a new study published in the American Journal of Epidemiology.

Researchers at Brigham and Women’s Hospital in Boston analyzed data from over 55,000 women between the ages of 48 and 73 enrolled in the Nurses’ Health Study, a long-term study that began in 1976.

They found that about 1 in 6 women who used ibuprofen or acetaminophen for at least six years suffered some degree of hearing loss. No such link was found in the women who used regular doses of aspirin.

“Although the magnitude of higher risk of hearing loss with analgesic use was modest, given how commonly these medications are used, even a small increase in risk could have important health implications,” said senior author Gary Curhan, MD, a physician in the Channing Division of Network Medicine at Brigham and Women’s Hospital.

“Assuming causality, this would mean that approximately 16.2 percent of hearing loss occurring in these women could be due to ibuprofen or acetaminophen use.”

Curhan noted the study was limited to mostly older, white women participating in the Nurses’ Health Study and that further investigation with larger and more diverse populations would be needed to better understand the connection between hearing loss and pain reliever use.

The researchers have previously published findings that indicate high frequency use of non-steroidal anti-inflammatory drugs (NSAIDS) and acetaminophen is associated with hearing loss in men and younger women. High doses of aspirin have also been associated with hearing loss.

The new study did not look at why the medications affect hearing, but previous research suggests the pain relievers affect blood and oxygen flow to sensitive parts of the ear that may compromise hearing.

About two- thirds of women in the U.S. over the age of 60 report some degree of hearing loss.

“Hearing loss is extremely common in the United States and can have a profound impact on quality of life,” said Curhan. “Finding modifiable risk factors could help us identify ways to lower risk before hearing loss begins and slow progression in those with hearing loss.”

Many people wrongly believe that over-the-counter pain relievers are relatively safe because they are available without a prescription. But studies have linked NSAIDs and acetaminophen to cardiovascular disease, hypertension, kidney problems and liver failure.

“I worry that people think NSAIDs and acetaminophen are completely safe, and that they don’t need to think about their potential (side effects),” Curhan told Time.  “But particularly for people who are taking them for chronic pain, I try to encourage them to look at why they are having the pain, not what they can take to try to treat the pain.”

Acetaminophen Linked to Kids’ Behavior Problems

By Pat Anson, Editor

Another study has linked acetaminophen to attention deficit and other behavioral problems in children whose mothers used the over-the-counter pain reliever while pregnant.

"Children exposed to acetaminophen use prenatally are at increased risk of multiple behavioral difficulties,” said lead author Evie Stergiakouli, PhD, of the University of Bristol. “Given the widespread use of acetaminophen among pregnant women, this can have important implications on public health advice.”

The study, published in JAMA Pediatrics, involved nearly 7,800 mothers in the UK who used acetaminophen in 1991 and 1992.

Prenatal use of acetaminophen in the second and third trimesters was associated with a higher risk of behavior problems and hyperactivity in children. Use of acetaminophen at 32 weeks of pregnancy was also associated with a higher risk for emotional problems.

“We found stronger association between maternal acetaminophen use and multiple behavioral and emotional problem domains during the third trimester than during the second trimester, in agreement with previous studies that have included multiple measurement times during pregnancy," said Stergiakouli. 

"Given that there is active brain development and growth during the third trimester, this finding could indicate that there are developmental periods when the brain is more sensitive to acetaminophen exposure.” 

Acetaminophen (paracetamol) is one of the most widely used pain relievers in the world. It is the active ingredient in Tylenol, Excedrin, and hundreds of other pain medications. Researchers say over half the pregnant women in the United States and European Union use the drug.

"The risk of not treating fever or pain during pregnancy should be carefully weighed against any potential harm of acetaminophen to the offspring," said Stergiakouli. 

A recent study of over 2,600 Spanish women linked acetaminophen to autism and attention deficit problems in their children. Studies in Denmark and New Zealand have also linked acetaminophen with a higher risk of hyperkinetic disorders and attention-deficit hyperactivity disorder (ADHD).

Over 50 million people in the U.S. use acetaminophen each week to treat pain and fever. The pain reliever has long been associated with liver injury and allergic reactions such as skin rash.