Kolodny: NSAIDs ‘Just as Effective As Opioids’

By Pat Anson, PNN Editor

It’s fair to say that Dr. Andrew Kolodny is recognized as an expert in substance abuse. Koldony is board-certified in Psychiatry and Addiction Medicine, and for a few years was the Chief Medical Officer of Phoenix House, which operates a chain of addiction treatment centers. He now co-directs an opioid research program at Brandeis University.

Kolodny is also the founder of the anti-opioid activist group Physicians for Responsible Opioid Prescribing (PROP), has testified as a well-paid expert witness in opioid litigation, and is frequently quoted in the media about opioid painkillers, often calling them “heroin pills.”

But Kolodny is not board-certified in pain management and is not recognized as an “expert” in treating physical pain. So it was a bit of a surprise to hear him giving medical advice about over-the-counter pain relievers last week in a webinar held by the Partnership for a Drug-Free New Jersey.

"Many people don't know this, but the class of analgesic known as NSAIDs are as effective and in some cases more effective than opioids, even for excruciating painful conditions like renal colic. It's also called kidney stone pain. NSAIDs have been shown to be just as effective,” Kolodny said.  

Non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin and ibuprofen are widely used to treat minor pain and headaches, but they are not generally used for severe or chronic pain.  

We asked Mary Maston what she thought about Kolodny’s advice. She is an expert on kidney stone pain, having been born with a congenital disorder called medullary sponge kidney (MSK), which causes her kidneys to continually produce new stones.  

“The class of analgesic known as NSAIDs are as effective and in some cases more effective than opioids, even for excruciating painful conditions.”

— Dr. Andrew Kolodny

“I wholeheartedly disagree that NSAIDs are as effective and in some cases more effective than opioids,” Maston told us. “My first thought was, ‘I wonder if he's ever had a kidney stone?’ Ask any patient that has, whether they have MSK like me or not, and they will quickly tell you that over-the-counter NSAIDs do absolutely nothing for kidney stone pain. I have never encountered a single patient that has said they just took some Aleve and that took care of the pain even a little bit.” 

Kolodny was just getting started. He also recommended acetaminophen (Tylenol) as an alternative to opioids, and said it can be combined with ibuprofen (Advil) for even stronger pain relief. 

“Tylenol is not as strong a pain reliever as NSAIDs, but can for some people be very effective. And fortunately, you can actually combine a drug like Advil with a drug like Tylenol because they work differently. As long as a patient is able to take Tylenol and is able to take Advil, as long as they don't have a contradiction to taking those medications, they can even be combined,” Kolodny said. 

“The combination of Tylenol and Advil is actually first-line for wisdom tooth removal, even though in many cases dentists often still give drugs like hydrocodone or oxycodone to teenagers when their wisdom teeth come out. Tylenol and Advil combined gives better pain relief, with less side effects." 

“What he said about kidney stones is not correct. In fact, it’s cruel. What he said about tooth extractions is correct,” says Jeffrey Fudin, PharmD, an expert in pharmacology and pain management. “But encouraging expanded chronic NSAID use without preliminary discussion with a physician or pharmacist is bad and he is oversimplifying. Pain source, cause, quality and quantity all need to be assessed. 

“And he didn’t offer what should be done for those patients that can’t take NSAIDs due to medical disorders or who can’t tolerate them or they don’t work. What do we do, not treat them?” 

Risky Side Effects of OTC Drugs

NSAIDs and acetaminophen are widely used over-the-counter pain relievers, and both can have serious side effects. NSAIDs increase the risk of heart attacks and stroke, while excessive use of acetaminophen can cause liver, kidney, heart and blood pressure problems. A recent study found little or no evidence to support the use acetaminophen for most pain conditions.  

Kolodny, who does not speak with this reporter, briefly acknowledged some of those issues during the webinar. 

“Some patients have medical problems where they are not able to take an NSAID. And sometimes for severe acute pain there is a role for opioids. But that should always be very short-term use. Or if it's ever prescribed for a chronic pain condition, intermittent use, meaning not taken every day. Because when opioids are taken every day, quickly patients develop tolerance to the pain-relieving effect,” Kolodny said. 

“He makes it sound as though it’s either opioids or NSAIDS/acetaminophen,” Fudin said in an email to PNN. “There are lots of options that can be used instead of opioids or in addition to opioids other than NSAIDs/acetaminophen in an effort to combine multiple different pharmacological mechanisms permitting lower doses of several drugs.”

An over-the-counter pain reliever that combines ibuprofen and acetaminophen was recently introduced called Advil Dual Action, but it is marketed as a treatment for “minor aches and pains” such as headaches, toothaches and menstrual cramps. Nothing about severe pain, chronic pain or kidney stones.

“NSAIDs have been known to cause acute kidney failure in patients that have perfectly healthy kidneys, and my nephrologist says we don't want to tempt the gods,” says Mary Maston. “Once I explain this to ER doctors and anesthesiologists when I have surgery, they quickly nod and agree.”

Maston would like to see an end to one-size-fits-all approaches to pain care and for providers to treat patients as individuals. One way to do that is with CYP450 testing, which looks for enzymes that determine how effective a medication will be in a patient.

“I personally think it's time to stop cramming all patients into convenient little boxes and start making CYP450 tests mandatory for anyone who suffers with chronic conditions. It would take the guesswork out of prescribing, prevent patient suffering, and eliminate the stigma, abuse and neglect of chronic pain patients by their providers,” she said. 

Dr. Fudin would like to see Dr. Kolodny stay in his lane as a psychiatrist and addiction treatment doctor. 

“Would it be okay for a board-certified pain specialist professing to be an expert and to opine under those circumstances on best drugs for schizophrenia?” asked Fudin.

Ibuprofen Linked to Reduced Male Fertility

By Pat Anson, Editor

If you’re a man who uses ibuprofen regularly for muscle pain or  headache, you could be compromising your ability to have children, according to a small new study.

French and Danish researchers enrolled 31 young male volunteers between the ages of 18 and 35 in the study, and gave about half of them 600 milligrams of ibuprofen twice a day -- the highest recommended dose. The other participants were given a placebo.

After just 14 days, the researchers noted signs of hormonal dysfunction in the men who took ibuprofen, who had high levels of luteinizing hormone, which the pituitary gland produces to stimulate testosterone production in the testicles. 

That condition -- known as hypogonadism -- is usually seen in older men who have low testosterone levels. Hypogonadism is associated with reduced fertility, lower sex drive, depression, fatigue and an increased risk of cardiovascular problems.

“We normally see this condition in elderly men, so it raises an alarm,” study co-author Bernard Jégou, PhD, of the French National Institute of Health and Medical Research, told The Guardian. “We are concerned about it, particularly for healthy people who don’t need to take these drugs. The risk is greater than the benefit.” 

Researchers say the disorder was mild in the ibuprofen group and went away when the men stopped taking ibuprofen. But they worry what would happen to men who take the pain reliever for longer periods. Many professional athletes regularly take high doses of ibuprofen.

“Our immediate concern is for the fertility of men who use these drugs for a long time,” said co-author David Møbjerg Kristensen, PhD, a professor of biology at the University of Copenhagen. “These compounds are good painkillers, but a certain amount of people in society use them without thinking of them as proper medicines.”

The study was published online in the Proceedings of the National Academy of Sciences .

“Ibuprofen appears to be the preferred pharmaceutical analgesic for long-term chronic pain and arthritis. Therefore it is also of concern that men with compensated hypogonadism may eventually progress to overt primary hypogonadism, which is characterized by low circulating testosterone and prevalent symptoms including reduced libido, reduced muscle mass and strength, and depressed mood and fatigue,“ the researchers warned.

The same team of researchers reported in earlier studies that aspirin, acetaminophen and ibuprofen affected the testicles of male babies born to mothers who took the drugs during pregnancy.

Ibuprofen is a widely used over-the-counter pain reliever found in brand name products such as Motrin and Advil.   

FDA: 'Everyone May Be at Risk' from NSAIDs

By Pat Anson, Editor

Warning that "everyone may be at risk," the U.S. Food and Drug Administration has ordered warning labels for non-steroidal anti-inflammatory drugs(NSAIDs) to be strengthened to indicate they increase the risk of a fatal heart attack or stroke.

The warning applies to ibuprofen, Advil, Motrin and other popular pain relievers sold over-the-counter, as well as prescriptions drugs containing NSAIDs. Many multi-symptom cold and flu products also contain NSAIDs.

The agency said studies have shown the risk of serious side effects can occur in the first few weeks of using NSAIDs and could increase the longer people use the drugs. The revised warning does not apply to aspirin.

“There is no period of use shown to be without risk,” says Judy Racoosin, MD, deputy director of FDA’s Division of Anesthesia, Analgesia, and Addiction Products.

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 for a serious cardiovascular event associated with NSAIDs. But the risk is also present for people who don't have heart problems.

“Everyone may be at risk – even people without an underlying risk for cardiovascular disease,” Racoosin said.

NSAIDs are widely used to treat everything from fever and headache to low back pain and arthritis. They are in so many different pain relieving products that health officials believe many consumers may not be aware how often they use NSAIDs. 

“Be careful not to take more than one product that contains an NSAID at a time,” said Karen Mahoney, MD, deputy director of FDA’s Division of Nonprescription Drug Products.

The labels for both prescription and over-the-counter NSAIDs already have information warning of heart attack and stroke risk. In the coming months, FDA will require drug manufacturers to update their labels with more specific information warning that the risk is heightened even in the first few weeks of use.

“Consumers must carefully read the Drug Facts label for all nonprescription drugs. Consumers should carefully consider whether the drug is right for them, and use the medicine only as directed. Take the lowest effective dose for the shortest amount of time possible," Mahoney said.

Several recent studies have found that NSAIDs increase the risk or heart attack and other health problems. The exact cause is unclear, but researchers believe NSAIDs may raise blood pressure and fluid retention, which can affect how the heart functions.  

A 2013 study published in The Lancet warned that high doses of NSAIDs may increase the risk of heart problems by about a third. In a review of over 600 clinical trials involving more than 353,000 patients, researchers found that NSAIDs doubled the risk for heart failure. People on high doses of the drugs also had up to four times greater risk for bleeding ulcers or gastrointestinal problems.

Another large study at the University of Florida in 2014 found that the over-the counter pain reliever naproxen raises the risk of a heart attack, stroke and death in postmenopausal women. Naproxen is a NSAID and the active ingredient in Aleve and other pain relievers commonly used to treat arthritis.

Studying data from over 160,000 postmenopausal women participating in a study funded by the National Institutes of Health, researchers estimated that using naproxen just twice a week raises the risk of cardiovascular problems by about 10 percent. The same study did not find a higher risk of a heart attack, stroke and death associated with ibuprofen, another type of NSAID.