painkiller

Painkiller or Soul-Killer? The Troubling Connection Between Tylenol and Decreased Empathy

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Popping a Tylenol for physical pain has become second nature for many – but groundbreaking research suggests this common painkiller may also be numbing our emotional capacity for caring, with potentially profound social consequences.

For many, reaching for a Tylenol to relieve a headache or sore muscles has become almost automatic. But groundbreaking research suggests that while this popular over-the-counter drug may effectively dull physical pain, it could also be numbing users’ ability to empathize with others on an emotional level – a side effect with deeply troubling societal implications.

A study published last month in Frontiers of Psychology adds to the growing body of evidence that acetaminophen (the generic name for Tylenol) reduces empathy for others’ suffering.1 Researchers at Ohio State University conducted a double-blind, randomized trial in which 114 college students received either 1,000 milligrams of acetaminophen or a placebo. One hour later, participants read scenarios depicting the experiences of various protagonists.

The results were striking: those who had taken acetaminophen reported significantly lower empathic concern and personal distress in response to the characters’ misfortunes compared to the placebo group.1 Notably, even positive empathy was dampened, with the acetaminophen users experiencing less vicarious joy for the protagonists’ uplifting experiences.1 As the authors note, these muted emotional reactions raise concern given the role of empathy in fostering compassion, connection, and prosocial behavior.1

This was not the first study to highlight acetaminophen’s psychosocial side effects. A seminal 2016 paper by some of the same Ohio State researchers first revealed that a typical dose of the drug blunted participants’ empathy for others’ pain, as measured by brain activity and subjective ratings.2 The authors sounded an early alarm:

“Because empathy regulates prosocial and antisocial behavior, these drug-induced reductions in empathy raise concerns about the broader social side effects of acetaminophen, which is taken by almost a quarter of adults in the United States each week.”2

Since then, evidence of acetaminophen’s psychological risks has only mounted. A 2019 study by the Ohio State team showed that the drug inhibited users’ ability to share in others’ positive experiences, suggesting effects on empathy beyond reactions to physical pain alone.3 Once again, the researchers warned about potential consequences, as “taking pleasure from the good fortune of others fosters interpersonal connection, trust, and – ultimately – prosocial behavior.”3

Other unsettling behavioral changes have also surfaced. Just last year, Baldwin Way, an Ohio State psychology professor who co-authored the empathy studies, published findings that acetaminophen made participants more willing to take risks.4 Compared to a placebo group, those given 1,000mg of the drug not only rated hypothetical activities like skydiving and unsafe sex as less risky, but also took more risks in a computerized task to earn rewards.4

Coupled with the empathy deficits, these disinhibiting effects paint a worrisome picture. As Way commented, considering that a quarter of American adults take acetaminophen each week, “even slight changes in risk-taking behavior could have important effects on society.”4 Other research has linked greater risk-taking on this type of simulated task with increased likelihood of real-world risky behaviors like stealing, substance use, and reckless driving.5

So how exactly does acetaminophen exert these effects on the mind? The answer likely lies in the brain regions it targets. Neuroimaging studies show that the drug reduces activity in areas like the anterior insula and anterior cingulate cortex,6,7 which are involved in processing both physical and social pain, as well as positive empathy.1 By tamping down these key emotional centers, acetaminophen may provide physical relief at the cost of emotional blunting.

The picture that emerges is one of a medication that, while highly effective at treating aches and pains, may also numb the emotional capacities that make us fully human. As the Ohio State researchers argue, acetaminophen’s “broader psychological effects…may have profound social implications that are only now beginning to be understood.”1

These discoveries underscore the importance of holistic approaches to pain management that address root causes rather than simply masking symptoms. They also highlight the risks of viewing any drug, even familiar over-the-counter remedies, as completely benign. With acetaminophen in particular, the ease of access and assumption of safety8 belie the major questions that remain about long-term psychological impacts, especially at a societal level.

As more and more evidence links this common painkiller to deficits in quintessentially human traits like empathy, it serves as a clarion call to reevaluate the full spectrum of effects – both intended and unintended – of one of the most widely consumed drugs on the planet. The health of our bodies and our social fabric may very well depend on it.

As Overdose Deaths Soar To Record Highs, FDA Approves New Painkiller 1,000x MORE Powerful Than Morphine

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Purdue Pharma and other pioneers of powerful opioid painkillers probably felt a twinge of regret on Friday when the FDA approved a powerful new opioid painkiller that’s 10 times stronger than fentanyl  – the deadly synthetic opioid that’s been blamed for the record number of drug overdose deaths recorded in 2017 – and 1,000 times more powerful than morphine, ignoring the objections of lawmakers and its own advisory committee in the process.

After all that trouble that purveyors of opioids like Purdue and the Sackler family went to in order to win approval –doctoring internal research and suborning doctors to convince the FDA to approve powerful painkillers like OxyContin despite wildly underestimating the drug’s abuse potential – the agency might very well have approved those drugs any way? And opioid makers might have been able to avoid some of the legal consequences stemming from this dishonesty, like the avalanche of lawsuits brought by state AGs.

What’s perhaps even more galling is that the FDA approved the drug after official data showed 2017 was the deadliest year for overdose deaths in US history, with more than 70,000 recorded drug-related fatalities, many of which were caused by powerful synthetic opioids like the main ingredient in Dsuvia, the brand name under which the new painkiller will be sold.

Dsuvia is a 3-millimeter tablet of sufentanil made by AcelRx. It’s a sublingual tablet intended to provide effective pain relief in patients for whom most oral painkillers aren’t effective. The FDA’s advisory committee voted 10-3 to recommend approval of the drug, a decision that was accepted by the FDA on Friday. The agency justified its decision by insisting that Dsuvia would be subject to “very tight” restrictions.

“There are very tight restrictions being placed on the distribution and use of this product,” said FDA Commissioner Scott Gottlieb in a written statement Friday regarding his agency’s approval of Dsuvia. “We’ve learned much from the harmful impact that other oral opioid products can have in the context of the opioid crisis. We’ve applied those hard lessons as part of the steps we’re taking to address safety concerns for Dsuvia.”

Still, some of the agency’s actions looked to critics like attempts to stifle internal criticism. For example, the agency scheduled the advisory committee vote on a day where the chairman of the committee, who was opposed to approval, could not attend – while circumventing its normal vetting process, despite the fact that the member in question had notified the agency of his unavailability months beforehand.

But the FDA rejected any and all criticisms related to Dsuvia being sold as a street drug by insisting that the risk of diversion (when doctor-prescribed drugs are illicitly sold on the black market) was low because the drug would only be prescribed in hospital settings, and wouldn’t be doled out at pharmacies. But critics said that, given its potency, Dsuvia would “for sure” be diverted at some level. They also rejected the FDA’s argument that Dsuvia satisfied an important need for pain treatment: offering rapid, effective relief for obese patients or others lacking easily accessible veins.

While a niche may eventually be found for Dsuvia, “it’s not like we need it…and it’s for sure, at some level, going to be diverted,” said Dr. Palmer MacKie, assistant professor at the Indiana University School of Medicine and director of the Eskenazi Health Integrative Pain Program in Indianapolis. “Do we really want an opportunity to divert another medicine?”

Fortunately for Dsuvia’s manufacturer, AcelRx, these public health risks pale in comparison to the enormous profits that the company stands to reap from sales. The company anticipates $1.1 billion in annual sales, and hopes to have its product in hospitals early next year.

It goes without saying that cancer patients and others suffering from life threatening illnesses have a legitimate need for effective pain relief. But when the FDA says Dsuvia is needed in the hospital setting, it probably isn’t telling the whole story. Because, as the Washington Post pointed out, the medication’s development was financed in part by the Department of Defense, which believes Dsuvia will be an effective treatment for emergency pain relief on the battlefield – like when a soldier gets his legs blown off after accidentally stepping on an IUD.

Prescriptions Continue for Most Who Survive Painkiller ODs: Study

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Even as overdoses from narcotic prescription painkiller reach record levels in the United States, a new report finds that most people who survive such events continue to be prescribed the drugs by their doctors.

News Picture: Prescriptions Continue for Most Who Survive Painkiller ODs: Study

The new study found that this happened in more than 90 percent of cases, and patients who continued on drugs like OxyContin, Vicodin and Percocet after an overdose had twice the odds of overdosing again within the next two years.

“Seventy percent of patients who overdosed were getting their drugs from the same doctor who prescribed the narcotic before the overdose,” noted lead researcher Dr. Marc Larochelle, an assistant professor of medicine at Boston University School of Medicine.

In many cases, doctors who continued to prescribe the narcotics didn’t even know that their patients had suffered an overdose. “This signals a problem with the health system, but I don’t think it necessarily fingers doctors as being bad doctors,” he said.

The problem, he said, is that emergency department records rarely find their way to a patient’s doctor. That’s because the record of an overdose is not automatically sent to the doctor who prescribed the drug, Larochelle said.

And patients, especially those addicted to these drugs, often don’t tell their doctor about winding up in the ER after an overdose.

For the study, Larochelle and colleagues used a large insurance claims database to collect information on nearly 3,000 people who overdosed on narcotic painkillers over 12 years. The report was published Dec. 28 in the Annals of Internal Medicine.

So what’s the solution? Larochelle believes that prescribing physicians first need to curb how often they write these prescriptions.

“There is a direct correlation that the more narcotics you put in the population, the more overdoses you are going to have,” he said.

According to the U.S. Centers for Disease Control and Prevention, drug overdoses are at epidemic levels, as are the rates of related overdose deaths.

A CDC report released earlier this month found that drug overdose deaths reached record highs in 2014, fueled largely by the abuse of narcotic painkillers and heroin — a drug addicts often turn to when their prescriptions are cut off.

In 2014, more than 47,000 Americans died from drug overdoses — a 14 percent increase over 2013. Since 2000, nearly half a million people have died from overdoses, the CDC said.

Oxycodone, which includes the brand-name drug OxyContin, and hydrocodone, which is in the brand-name drug Vicodin, continue to be among the most commonly prescribed narcotic painkillers, and are responsible for more overdose deaths than any other narcotic, the researchers found.

Now, “doctors are trying to find a balance in prescribing narcotic painkillers between the risk and potential benefits,” Larochelle said.

Do patients need to be on these high-strength painkillers over the long term?

Larochelle say it’s doubtful. He said that while the drugs are effective in controlling pain after surgery and managing pain for cancer patients, they have not been proven effective at controlling chronic, non-cancer pain such as back pain.

In addition, Larochelle said no tool exists that can predict which patients will become addicted to these drugs. “Ideally, we would be able to identify those patients,” he said.

He also believes that better communication between ERs and doctors who prescribed these drugs is key. For example, insurance companies might be able to provide information on overdoses to doctors, which could help them spot patients who are having problems with the drugs, Larochelle said.

Dr. Scott Krakower is assistant unit chief of psychiatry at Zucker Hillside Hospital in Glen Oaks, N.Y. He said that “narcotic painkillers can be highly addictive and patients may seek them out despite overdose, thus ignoring risks with these agents.”

But he said the medical community is increasingly opting for tighter controls of these agents. For example, in states with a prescription monitoring program, doctors can check the database to see if their patients have had an overdose or are getting prescriptions from several doctors, Krakower said.

Doctors should also avoid prescribing large quantities of narcotics and should understand the risks involved with dispensing multiple drugs, such as narcotics and benzodiazepines. Benzodiazepines, such as Valium, Xanax and Klonopin, are used for treating anxiety, panic attacks, depression and insomnia. They don’t mix well with narcotic painkillers and can causebreathing difficulties that can be fatal.

Krakower said doctors need to communicate better with patients who have overdosed to prevent them from getting in trouble again.

“In the future doctors should aim to ensure that they facilitate adequate handoffs between each other, especially from the emergency room or inpatient settings to outpatient providers,” he said.

FDA Approves Generic Version of Painkiller Celebrex.

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The U.S. Food and Drug Administration on Friday gave its approval to the first generic version of the powerful pain reliever Celebrex (celecoxib).

Celecoxib is a member of the cox-2 inhibitor family of painkillers, prescription medicines often used for arthritis and other conditions. The drugs emerged in the early 2000s and included once best-selling pain relievers such as Vioxx and Bextra.

However, Vioxx was pulled from the market in 2004 after studies revealed use of the drug raised heart risks, and the withdrawal of Bextra followed a year later. Celebrex has remained the only cox-2 inhibitor medication on drugstore shelves in the years since.

On Friday, Teva Pharmaceutical Industries got the nod from the FDA to market cheaper generic versions of celecoxib capsules in 50 milligram, 100 mg, 200 mg, and 400 mg strengths. Mylan Pharmaceuticals Inc. received permission to market 50 mg celecoxib capsules, the agency said.

“It is important for patients to have access to affordable treatment options for chronic conditions,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in an agency statement. “Health care professionals and patients can be assured that these FDA-approved generic drugs have met our rigorous approval standards.”

Celecoxib also falls into the category known as a non-steroidal anti-inflammatory drug (NSAID). According to the FDA, like all NSAID medications, generic celecoxib will “have a Boxed Warning in their prescribing information (label) to alert health care professionals and patients about the risk of heart attack or stroke that can lead to death. This chance increases for people with heart disease or risk factors for it, such as high blood pressure, or taking NSAIDs for long periods of time.”

The FDA noted that potential side effects of celecoxib for people with arthritis include “abdominal pain, diarrhea, indigestion (dyspepsia), flatulence, swelling of the feet or legs (peripheral edema), accidental injury, dizziness, inflammation of the throat (pharyngitis), runny nose (rhinitis), swollen nasal passages, (sinusitis), upper respiratory tract infection, and rash.”

Antidepressants: Another weapon against chronic pain

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Some of the more effective and commonly used medications for chronic pain are drugs that were developed to control other conditions. Antidepressants are a mainstay in the treatment of many chronic pain conditions — even when depression isn’t a factor.

Tricyclics used most often

Tricyclic antidepressants are the most common type used for pain. They include:

  • Amitriptyline
  • Imipramine (Tofranil)
  • Clomipramine (Anafranil)
  • Nortriptyline (Pamelor)
  • Desipramine (Norpramin)
  • Doxepin (Sinequan)

Types of pain relieved

Tricyclic antidepressants seem to work best for pain caused by:

  • Nerve damage from diabetes (diabetic neuropathy)
  • Nerve damage from shingles (postherpetic neuralgia)
  • Tension headache
  • Migraine
  • Fibromyalgia
  • Low back pain

The painkilling mechanism of these drugs is still not fully understood. Tricyclic antidepressants may increase neurotransmitters in the spinal cord that reduce pain signals. But they don’t work immediately. You may have to take a tricyclic antidepressant for several weeks before it starts reducing your pain.

Side effects usually mild

Side effects of tricyclic antidepressants may include:

  • Drowsiness
  • Dry mouth
  • Constipation
  • Weight gain
  • Difficulty with urination
  • Changes in blood pressure

To reduce or prevent side effects, your doctor will likely start you at a low dose and slowly increase the amount. Most people are able to take tricyclic antidepressants, particularly in low doses, with only mild side effects. The doses that are effective for pain are typically lower than the doses used for depression.

Other antidepressants that may help

Drugs such as venlafaxine (Effexor) and duloxetine (Cymbalta) can relieve many of the same types of painful conditions that are eased by tricyclic antidepressants. Known as serotonin and norepinephrine reuptake inhibitors (SNRIs), these drugs don’t work quite as well as tricyclic antidepressants, but they also don’t produce as many side effects.

Selective serotonin reuptake inhibitors (SSRIs) such as paroxetine (Paxil) and fluoxetine (Prozac) don’t appear to help relieve pain on their own. However, fluoxetine appears to boost the painkilling effects of some tricyclic antidepressants.