An Open Letter to Attorney General Jeff Sessions

By Fred Brown, Guest Columnist

Dear Honorable Attorney General Jeff Sessions,

Why are there are so many federal agencies, like the CDC, DEA and Justice Department, that want to take away my opioid medication?  I have a right to be treated humanely, don’t I?

I am an American citizen who has dealt with some serious and painful medical issues. Over 20 years ago, I was referred to a board-certified pain management physician.  This was due to two failed cervical surgeries that left me with chronic back pain. I had two additional surgeries to fuse my spine after the first two operations, which only made my pain even more severe. The pain physician recommended I should begin a treatment regimen that included low doses of opioid medication.  

These medications helped me to continue working and have a certain quality of life.  I knew from discussions with my physician that, over time, I would need to increase the dose as my body would become dependent on opioids. This has been necessary and over many years these medications helped me live my life.

I have tried other medical modalities such as physical and occupational therapy, biofeedback, acupuncture, counseling, and other alternative treatments.  Further, before starting on opioids, I tried various non-narcotic medicines which did not work.    

Mr. Attorney General, earlier this year, you gave a talk in Tampa and said, “People need to take some aspirin sometimes and tough it out.” 

Perhaps if someone was experiencing mild discomfort, aspirin will work.  However, when one is living with severe chronic pain, 24-hours a day, seven days a week, they very likely need strong opioids prescribed by their physician.

Opiates help patients like me get relief from severe pain. They do not take away the pain, but they help reduce it and enable us to have some quality of life.  

ATTORNEY GENERAL JEFF SESSIONS

ATTORNEY GENERAL JEFF SESSIONS

The “pill mills” have hurt many people, and most certainly the DEA should do everything it can to close them down.  But at the same time, certain patients must have high dosages of these medications. Each of us have a different metabolism and what may work for one person at one dose level may not work at all with another patient.  

When a government agency such as the DEA goes after physicians who are trying to help legitimate patients, without any idea of the patients’ history is and why they are on high doses, that is entirely wrong and inhumane!

Why are so many agencies, along with Congress, trying to keep these medications at lower dosages that will cause me to live with increased pain?  Does our nation intend to condemn citizens who have painful and excruciating disabilities to a life of agony?

I am aware the CDC made some serious mistakes when it released the 2016 Opioid Prescribing Guideline.  Some physicians believe the guideline is law and began to lower the doses of patients or even discharge them from their practice. It took CDC researchers years to admit they significantly inflated deaths from opioid prescriptions because they misreported deaths due to illegal fentanyl. 

Opioid prescriptions have been declining since 2011, while overdose deaths and suicides are at an all-time high!  This is not accidental.  CDC, FDA and DEA are chasing the wrong opioid epidemic and needlessly ruining lives of people in pain.

Mr. Attorney General, was our nation founded on the premise that our fellow citizens should live in chronic severe pain? I do not believe our Founding Fathers would want this. 

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Fred Brown lives in central Florida. Fred is disabled because of spinal fusion with laminectomy syndrome, cervical radiculitis.  He also has severe arthritis in bilateral knees with a failed knee replacement.  In addition to pain management, Fred uses "diversion of the mind" as a way of dealing with much discomfort. 

Pain News Network invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Jeff Sessions, Aspirin and Toughing It Out

By Crystal Lindell, Columnist

My first reaction to reading that Attorney General Jeff Sessions thinks pain patients should just “tough it out” was probably not appropriate for this publication.

My second reaction probably wasn’t either.

If you haven’t heard, Sessions hates drugs. Like a lot. He literally once said, “good people don’t smoke marijuana.”

And now, he apparently thinks good people shouldn’t use opioid pain medication.

"I am operating on the assumption that this country prescribes too many opioids," Sessions said during a speech at the U.S. Attorney’s office in Tampa. "People need to take some aspirin sometimes and tough it out.”

Okay. Look. Setting aside the fact that data consistently shows that most people do not start heroin because they received a legitimate hydrocodone prescription, let’s talk about this whole idea of “toughing it out.”

Because that’s the thing about pain, when it’s not yours, it’s incredibly easy to endure. All you really have to do is throw around clichés about being a strong person, and maybe sprinkle in some lame advice about yoga and acupuncture.

Depending on your mood, you might even add in a few judgmental asides about avoiding gluten and getting enough exercise. And just like that: Voila! You’ve dealt with it! Problem solved.

But when it’s your pain. When it’s eating away at your soul, it’s never that easy. And it never gets easy.

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Left untreated, the pain that wraps around the right side of my ribs has left me dreaming of drowning in a bottle of Drano just to make it stop. It has buried me in bed and left me for dead, so heavy on my chest that I can’t get up. It has stolen my nights and destroyed my days. And it has done its very best to rob me of my hope. 

In short, it’s been hell. And the words that would make you truly understand how awful it has been do not exist.

But thankfully, I found a doctor who has helped me get through hell and manage my constant pain with opioid pain medications.

And it’s because of those medications that I can live. I can work. I can be a friend, and a sister, and a lover, and a writer, and daughter. I can be connected to the magic of the universe again.

There is so much we can do to fight the opioid epidemic. Those suffering from addiction need long-term treatment that includes professional psychiatric help. They need to be offered medicated withdrawal when needed, and given a strong support system. And they need empathy.

In fact, it’s the same empathy pain patients need, just applied differently.

I don’t expect a man like Jeff Sessions to understand this. He has never been in horrific pain. And honestly, as much as I hate him, I hope he never is.

But if he does wake up with pain one day, and realizes how important it is to treat that pain, I hope he looks back on his life with regret and remorse, as he realizes how incredibly wrong he was to ever suggest that people in pain “tough it out.”

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Crystal Lindell is a journalist who lives in Illinois. She loves Taco Bell, watching "Burn Notice" episodes on Netflix and Snicker's Bites. She has had intercostal neuralgia since February 2013.

Crystal writes about it on her blog, “The Only Certainty is Bad Grammar.”

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Sessions Tells Pain Patients to ‘Tough It Out’

By Pat Anson, Editor

Take two aspirin and call me in the morning.

That old cliché is finding new life – at least in the mind of U.S. Attorney General Jeff Sessions --- who suggested twice this week that aspirin is the solution to the nation’s opioid crisis.

"I am operating on the assumption that this country prescribes too many opioids," Sessions said during a Wednesday visit to the U.S. Attorney’s office in Tampa. "People need to take some aspirin sometimes and tough it out.”

During his 25-minute speech, the Tampa Bay Times reported that Sessions veered away from his prepared remarks to cite the example of White House chief of staff Gen. John Kelly, who refused to take opioid painkillers after recent minor surgery.

"He goes, ‘I’m not taking any drugs,’" Sessions said, drawing a laugh while imitating Kelly. "But, I mean, a lot of people — you can get through these things."

"That remark reflects a failure to recognize the severity of pain of some patients," said Bob Twillman, PhD, executive director of the Academy of Integrative Pain Management.

JEFF SESSIONS

JEFF SESSIONS

"It’s an unconscionable remark," Twillman told the Tampa Bay Times. "It further illustrates how out of touch parts of the administration are with opioids and pain management."

Sessions made similar statements Tuesday night at a Heritage Foundation event marking the birthday of President Ronald Reagan.

"Sometimes you just need to take two Bufferin or something and go to bed," said Sessions, who added that his goal in 2018 was to see a continuing decline in opioid prescriptions, which have been falling since 2010.

“We had a 7 percent decline last year in actual prescriptions of opioids. We think doctors are just prescribing too many,” he said. “These pills become so addictive. The DEA says a huge percentage of the heroin addiction starts with prescriptions. That may be an exaggerated number. They had it as high as 80 percent. We think a lot of this is starting with marijuana and other drugs too.”

Sessions was referring to a single but often-cited survey, which found that most heroin users in addiction treatment also abused prescription opioids. The fact is most addicts try a variety of different substances – such as tobacco, marijuana, alcohol and opioid medication – before moving on to heroin. It is rare for a legitimate patient on legally prescribed opioids to use heroin.  

The Drug Enforcement Administration – an agency that Sessions oversees – has ordered a reduction in the supply of prescription opioids in 2018. That’s in addition to steep cuts in opioid production quotas the DEA imposed in 2017.  The agency ignored dozens of public comments warning that further reductions this year in the opioid supply could create shortages.  

Aspirin Risky for Seniors 75 and Older

By Pat Anson, Editor

The old cliché about a doctor telling you to “take two aspirin and call me in the morning” isn’t such great advice after all. Especially for seniors aged 75 and older.

A daily dose of aspirin has long been recommended as a way to prevent a heart attack or stroke. But British researchers at the University of Oxford say the blood thinning effects of aspirin substantially raise the risk of gastrointestinal bleeding as patients grow older.

Their study, published in The Lancet medical journal, estimates that aspirin causes over 3,000 deaths in the U.K. annually.

“We have known for some time that aspirin increases the risk of bleeding for elderly patients. But our new study gives us a much clearer understanding of the size of the increased risk and of the severity and consequences of bleeds,” said lead author Professor Peter Rothwell.

“Previous studies have shown there is a clear benefit of short term anti-platelet treatment following a heart attack or stroke. But our findings raise questions about the balance of risk and benefit of long-term daily aspirin use in people aged 75 or over.”

Rothwell and his colleagues followed over 3,100 patients for 10 years who were prescribed a daily aspirin after a heart attack or stroke. For the patients under 65, the annual rate of bleeding severe enough to require hospitalization was about 1.5 percent. For patients aged 75-84, the annual rate rose to 3.5 percent and for patients over 85 it was 5 percent.

The researchers are not recommending that seniors stop taking aspirin. But they suggest that a proton-pump inhibitor – heartburn drugs – be prescribed along with aspirin to reduce the risk of bleeding.  They estimate that proton-pump inhibitors (PPIs) could reduce upper gastrointestinal bleeding by as much as 90% in patients receiving long-term aspirin treatment.

“While there is some evidence that PPIs might have some small long-term risks, this study shows that the risk of bleeding without them at older ages is high, and the consequences significant,” said Rothwell.

About half of adults aged 75 or older in the U.S. and Europe take aspirin or another anti-platelet drug daily .

What Cavemen Used for Pain Relief

By Pat Anson, Editor

Neanderthals may be a lot smarter than we give them credit for. Especially when it comes to finding pain relief.

Ancient DNA extracted from the dental plaque of Neanderthals has revealed new insights into their behavior and diet, including their use of plant-based medicine to treat pain and illness.

An international team of researchers compared dental plaque from the jawbones of four Neanderthals found at ancient cave sites in Belgium (Spy Cave) and Spain (El Sidrón Cave). The four samples range from 42,000 to around 50,000 years old and are the oldest dental plaque ever to be genetically analyzed.

“Dental plaque traps microorganisms that lived in the mouth and pathogens found in the respiratory and gastrointestinal tract, as well as bits of food stuck in the teeth – preserving the DNA for thousands of years,” says Dr. Laura Weyrich, a research fellow at the University of Adelaide’s Australian Centre for Ancient DNA (ACAD), who was lead author of the groundbreaking study reported in the journal Nature.

RESEARCHERS IN EL SIDRON CAVE

RESEARCHERS IN EL SIDRON CAVE

“Genetic analysis of that DNA ‘locked-up’ in plaque, represents a unique window into Neanderthal lifestyle – revealing new details of what they ate, what their health was like and how the environment impacted their behavior.”

The researchers found that Neanderthals from Spy Cave were mostly meat eaters who consumed wooly rhinoceros and wild sheep, and supplemented their diet with wild mushrooms.

“Those from El Sidrón Cave on the other hand showed no evidence for meat consumption, but appeared instead to have a largely vegetarian diet, comprising pine nuts, moss, mushrooms and tree bark – showing quite different lifestyles between the two groups,” said professor Alan Cooper, Director of ACAD.

The analysis of one Neanderthal found at El Sidrón revealed another surprise. He probably had pain from a dental abscess on his jawbone, and also had signs of an intestinal parasite that causes acute diarrhea.

“Clearly he was quite sick. He was eating poplar, which contains the pain killer salicylic acid, and we could also detect a natural antibiotic mold not seen in the other specimens,” said Cooper. “Apparently, Neanderthals possessed a good knowledge of medicinal plants and their various anti-inflammatory and pain-relieving properties, and seem to be self-medicating.”

Salicylic acid is the active ingredient in aspirin; while certain types of mold – such as Penicillium – help the body fight off infections.

JAWBONE OF NEANDERTHAL FOUND IN EL SIDRON CAVE

JAWBONE OF NEANDERTHAL FOUND IN EL SIDRON CAVE

“The use of antibiotics would be very surprising, as this is more than 40,000 years before we developed penicillin. Certainly our findings contrast markedly with the rather simplistic view of our ancient relatives in popular imagination,” says Cooper.

The researchers also found that Neanderthals and modern humans shared several disease-causing microbes, including the bacteria that cause dental cavities and gum disease.

Types of bacteria were closely associated with the amount of meat in the diet, with the Spanish Neanderthals grouping with ancient human ancestors in Africa. In contrast, the Belgian Neanderthal bacteria were similar to early hunter gatherers, and quite close to modern humans and early farmers.

“Not only can we now access direct evidence of what our ancestors were eating, but differences in diet and lifestyle also seem to be reflected in the commensal bacteria that lived in the mouths of both Neanderthals and modern humans,” said Professor Keith Dobney of the University of Liverpool.

“Major changes in what we eat have, however, significantly altered the balance of these microbial communities over thousands of years, which in turn continue to have fundamental consequences for our own health and well-being. This extraordinary window on the past is providing us with new ways to explore and understand our evolutionary history through the microorganisms that lived in us and with us.”

Ibuprofen No Better Than Placebo for Back Pain

By Pat Anson, Editor

When it comes to treating back pain, anti-inflammatory drugs such as ibuprofen work no better than a placebo, according to new Australian study.

Researchers at the University of Sydney conducted a meta-analysis (a study of studies) of 35 clinical trials involving over 6,000 people with back pain, and found that non-steroidal anti-inflammatory drugs (NSAIDs) provide little benefit. The study was published in the Annals of the Rheumatic Diseases.

NSAIDs are effective for spinal pain, but the magnitude of the difference in outcomes between the intervention and placebo groups is not clinically important. At present, there are no simple analgesics that provide clinically important effects for spinal pain over placebo,” wrote lead author Gustavo Machado, PhD, of The George Institute for Global Health. “There is an urgent need to develop new drug therapies for this condition.”

Back pain is the world’s leading cause of disability, with about 80 percent of adults experiencing back pain at some point in their lives.

Opioids are usually not prescribed for simple back pain, leaving patients little alternative but over-the-counter pain relievers such as NSAIDs, a class of drugs that includes both aspirin and ibuprofen. NSAIDs are known to raise the risk of gastrointestinal and cardiovascular problems.

The Australian study found that NSAIDs reduced pain and disability somewhat better than a placebo or dummy medication, but the results were not statistically important.

"NSAIDs do not provide a clinically important effect on spinal pain, and six patients must be treated with NSAIDs for one patient to achieve a clinically important benefit in the short-term," wrote Machado. “When this result is taken together with those from recent reviews on paracetamol (acetaminophen) and opioids, it is now clear that the three most widely used, and guideline-recommended medicines for spinal pain do not provide clinically important effects over placebo.”

The study did not evaluate non-pharmacological treatments for back pain, such as exercise, physical therapy or chiropractic care.

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

NSAIDs Raise Risk of Dying From Endometrial Cancer

By Pat Anson, Editor

Aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) have long been thought to reduce the risk of some cancers. But a surprising new study suggests that regular use of the pain relievers may actually raise the risk of dying for women with endometrial cancer.

Researchers at Ohio State University studied over 4,300 women with endometrial cancer, 550 of whom died during the five-year study. Those who used NSAIDs regularly and had Type 1 endometrial cancer had a 66 percent higher risk of death.

The research findings are published in the Journal of the National Cancer Institute.

"This study identifies a clear association that merits additional research to help us fully understand the biologic mechanisms behind this phenomenon. Our finding was surprising because it goes against previous studies that suggest NSAIDs can be used to reduce inflammation and reduce the risk of developing or dying from certain cancers," said co-author Theodore Brasky, PhD, a cancer epidemiologist at The Ohio State University Comprehensive Cancer Center.

Over 60,000 women are diagnosed with endometrial cancer in the U.S. annually, making it the fourth most common cancer in women and the sixth leading cause of cancer death.

Endometrial cancer begins in the lining of the uterus and grows outward to surrounding organs. Type 1 tumors are less aggressive and are typically confined to the uterus, while Type 2 tumors tend to be aggressive and are at greater risk of spreading.

In the OSU study, the risk of dying was statistically significant in women who reported past or current NSAID use, but it was strongest among patients who used NSAIDs for more than 10 years and had ceased using them prior to their cancer diagnosis.

Interestingly, the use of NSAIDs was not associated with mortality from more aggressive Type 2 cancers.

"These results are intriguing and worthy of further investigation," said co-author David Cohn, MD, director of the gynecologic oncology division at the OSU cancer center. “While these data are interesting, there is not yet enough data to make a public recommendation for or against taking NSAIDS to reduce the risk of cancer-related death."

Aspirin, ibuprofen and other NSAIDs are believed to lower the risk of some cancers by reducing inflammation, which slows the development of blood vessels that support the growth of cancer tumors. Inhibition of inflammation may have the opposite effect in endometrial cancer, but the reasons why are unclear.

Previous studies have shown that NSAIDs have a preventive effect on colorectal cancer and several other cancer types.

“Observational evidence of a chemopreventive effect of aspirin and other NSAIDs has been reported for esophageal, gastric, lung, breast, prostate, and colorectal cancer. Most of these cancers develop after age 60 years,”  researchers at the University of California Irvine reported in The Lancet.

“Given the apparent delay in the chemopreventive effect of NSAIDs (about 10 years), optimum treatment might start at age 40–50 years. Most individuals who develop premalignant lesions do so in their 50s and 60s, several years before the appearance of cancer, so this age range might be the best time for cancer prevention.”

Low-dose aspirin is also believed to have cardiovascular benefits. For that reason, the OSU researchers recommend that women keep taking the pain relievers.  

"It is important to remember that endometrial cancer patients are far more likely to die of cardiovascular disease than their cancer so women who take NSAIDs to reduce their risk of heart attack -- under the guidance of their physicians -- should continue doing so,” said Cohn.

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.”

1 in 6 Seniors Take Risky Drug Combinations

By Pat Anson, Editor

One in six older adults now regularly use potentially deadly combinations of prescription drugs, over-the-counter (OTC) medications and supplements, a two-fold increase over a five-year period, according to new research published in JAMA Internal Medicine.

Researchers at the University of Illinois at Chicago surveyed over 2,200 Americans between the ages of 62 and 85 and found that over half (54%) were taking some type of pain reliever in 2011.

Over 40 percent used aspirin; nearly 14% took non-steroidal anti-inflammatory drugs (NSAIDs); and about 11% used an opioid analgesic.

Only 44% were using a pain reliever in 2006.

Researchers identified 15 potentially life-threatening drug combinations of the most commonly used medications and supplements. Statins, anti-platelet drugs such as aspirin, and supplements (specifically omega-3 fish oil) accounted for the vast majority of interacting drug medications, some of which worsen cardiovascular problems. Opioids were not listed among the 15 risky combinations.

Nearly 15% of older adults regularly used at least one of the dangerous drug combinations in 2011, compared to 8% five years earlier.

"The risk seems to be growing, and public awareness is lacking," said Dima Mazen Qato, an assistant professor of pharmacy systems at the University of Illinois.

"Many older patients seeking to improve their cardiovascular health are also regularly using interacting drug combinations that may worsen cardiovascular risk. For example, the use of clopidogrel in combination with the proton-pump inhibitor omeprazole, aspirin, or naproxen -- all over-the-counter medications -- is associated with an increased risk of heart attacks, bleeding complications, or death.”

As Pain News Network reported, European researchers also warned last week that aspirin and some types of NSAID’s could be harmful to patients with heart or kidney problems. The researchers said NSAIDs, in particular, raise cardiovascular risk and there is no "solid evidence" the drugs are safe.

"When doctors issue prescriptions for NSAIDs, they must in each individual case carry out a thorough assessment of the risk of heart complications and bleeding. NSAIDs should only be sold over the counter when it comes with an adequate warning about the associated cardiovascular risks,” said Christian Torp-Pedersen, a professor in cardiology at Aalborg University in Denmark.

In opioid prescribing guidelines released last week, the Centers for Disease Control and Prevention recommends "nonopioid pharmacologic therapy" such as acetaminophen and NSAIDs as the "preferred" treatments for chronic pain. Only briefly do the CDC guidelines even mention that NSAIDs have been associated with cardiovascular risks or that acetaminophen may cause liver failure. Instead, the 52-page guideline focuses on the risks of opioid addiction and abuse.

Over half of the risky drug combinations in the University of Illinois study involved over-the-counter medications or dietary supplements.

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.