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Quantifying the Impact of NSAID-associated
Adverse Events

By |June 4, 2017|Iatrogenic Injury, NSAIDs|

Quantifying the Impact of NSAID-associated
Adverse Events

The Chiro.Org Blog


SOURCE:   Am J Manag Care. 2013 (Nov); 19 (14 Suppl): s267–272

Michael Fine, MD

Health Net
736 Kendall Dr
Laguna Beach, CA 92651


Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used among patients experiencing many different types of pain, including inflammatory, acute pain (eg, injury, low back pain, headache, postoperative pain), and chronic pain (eg, rheumatoid arthritis, osteoarthritis).

However, both traditional NSAIDs and second-generation NSAIDs (cyclooxygenase-2 inhibitors) can lead to very expensive and serious adverse events. Gastrointestinal, cardiovascular, and renal complications associated with NSAIDs have been shown to be dose-dependent. In 2005, to help minimize these risks, the US Food and Drug Administration issued a public health advisory stating that “NSAIDs should be administered at the lowest effective dose for the shortest duration consistent with individual patient treatment goals.”

This article reviews the undue clinical and economic burden associated with NSAID-related serious adverse events.


From the FULL TEXT Article:

Introduction

Nonsteroidal anti-inflammatory drugs (NSAIDs) are the cornerstone of pain management in patients who have inflammatory, acute pain (eg, headache, postoperative pain, and orthopedic fractures), and chronic pain (eg, rheumatoid arthritis, osteoarthritis, and gout). [1, 2] Approximately 70% of people 65 years or older use NSAIDs at least once per week, with half of them taking at least 7 doses per week. In 2000, more than 111 million prescriptions were written for NSAIDs in the United States, at an approximate cost of $4.8 billion. [3] The use of NSAIDs is likely to increase even more as the US population continues to age and experience painful conditions that are more common among older adults. [4]

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Australian study indicates common painkillers ineffective for back pain

By |February 7, 2017|NSAIDs|

Commonly used non-steroidal anti-inflammatory drugs used to treat back pain provide little benefit and may make things worse according to new research from The George Institute for Global Health.

The findings of the systematic review, published in the Annals of the Rheumatic Diseases, reveal only one in six patients treated with the pills, also known as NSAIDs, achieve any significant reduction in pain.

The study is the latest work from The George Institute questioning the effectiveness of existing medicines for treating back pain. Earlier research has already demonstrated paracetamol does not speed recovery or reduce pain for acute low back pain, and opioids provide minimal benefit over placebo.

Lead author Associate Professor Manuela Ferreira says the study highlights an urgent need to develop new therapies to treat back pain which affects 80 per cent of Australians during their lifetime.

A/Prof Ferreira, Senior Research Fellow at The George Institute and at the Institute of Bone and Joint Research, said: “Back pain is the leading cause of disability worldwide and is commonly managed by prescribing medicines such as anti-inflammatories. But our results show anti-inflammatory drugs actually only provide very limited short term pain relief. They do reduce the level of pain, but only very slightly, and arguably not of any clinical significance.”

A/Prof Ferreira added: “When you factor in the side effects which are very common, it becomes clear that these drugs are not the answer to providing pain relief to the many millions of Australians who suffer from this debilitating condition every year.”

The team at The George Institute, which examined 35 trials involving more than 6000 people, also found patients taking anti-inflammatories were 2.5 times more likely to suffer from gastro-intestinal problems such as stomach ulcers and bleeding.

Research Fellow Gustavo Machado, of The George Institute and the School of Medicine at the University of Sydney, said: “Millions of Australians are taking drugs that not only don’t work very well, they’re causing harm. We need treatments that will actually provide substantial relief of these people’s symptoms.

“Better still we need a stronger focus on preventing back pain in the first place. We know that education and exercise programs can substantially reduce the risk of developing low back pain.”

Most clinical guidelines currently recommend NSAIDs as the second line analgesics after paracetamol, with opioids coming at third choice.

 

FDA strengthens warning that non-aspirin NSAIDs can cause heart attacks or strokes

By |October 27, 2015|NSAIDs|

Source FDA

The U.S. Food and Drug Administration (FDA) is strengthening an existing label warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke. Based on their comprehensive review of new safety information, they are requiring updates to the drug labels of all prescription NSAIDs. As is the case with current prescription NSAID labels, the Drug Facts labels of over-the-counter (OTC) non-aspirin NSAIDs already contain information on heart attack and stroke risk. They will also request updates to the OTC non-aspirin NSAID Drug Facts labels.

Based on their review and the advisory committees’ recommendations, the prescription NSAID labels will be revised to reflect the following information:

  • The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID. The risk may increase with longer use of the NSAID.
  • The risk appears greater at higher doses.
  • It was previously thought that all NSAIDs may have a similar risk. Newer information makes it less clear that the risk for heart attack or stroke is similar for all NSAIDs; however, this newer information is not sufficient for us to determine that the risk of any particular NSAID is definitely higher or lower than that of any other particular NSAID.
  • NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease. A large number of studies support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied.
  • In general, patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke following NSAID use than patients without these risk factors because they have a higher risk at baseline.
  • Patients treated with NSAIDs following a first heart attack were more likely to die in the first year after the heart attack compared to patients who were not treated with NSAIDs after their first heart attack.
  • There is an increased risk of heart failure with NSAID use.

Tylenol Is Ineffective For Treating Low Back Pain or Disability.

By |April 18, 2015|NSAIDs|

The Limits of Tylenol for Pain Relief

The Chiro.Org Blog


SOURCE:   New York Times ~ April 1, 2015

By Nicholas Bakalar


Acetaminophen, also known as paracetamol (Tylenol) is widely recommended for the relief of back pain and the pain of knee and hip arthritis. But a systematic review of randomized trials has found that it works no better than a placebo.

Australian researchers reviewed three randomized trials that compared acetaminophen with a placebo for the relief of spinal pain, and 10 trials that compared their use for easing the pain of osteoarthritis. All together, the analysis included 5,366 patients. Acetaminophen was given orally in doses between 3,000 and 4,000 milligrams a day, except for one study in which a dose of 1,000 milligrams was administered intravenously.

The review, published online in BMJ (British Medical Journal), found high quality evidence that Tylenol is ineffective in treating low back pain or disability. It also found evidence that the drug quadruples the risk of an abnormal liver function test, but the clinical significance of that finding is unclear.

[Editor’s Note:   Actually, reports as far back as 2001 suggest that 36 percent of acute liver failures are linked to acetaminophen use. Would you like to guess what it costs for a liver transplant, plus the added costs of anti-rejection drugs for a lifetime?   Another review in the American Journal of Medicine estimates that 107,000 patients are hospitalized annually for nonsteroidal anti-inflammatory drug (NSAID)-related gastrointestinal (GI) complications (internal bleeding) and at least 16,500 NSAID-related deaths occur each year among arthritis patients alone.   The figures for all NSAID users would be overwhelming, yet the scope of this problem is generally under-appreciated, and under-reported.]

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FDA’s NSAID Panel Nixes Naproxen Safety Claim

By |February 11, 2014|Iatrogenic Injury, NSAIDs, Safety|

FDA’s NSAID Panel Nixes Naproxen Safety Claim

The Chiro.Org Blog


SOURCE:   MedPage Today ~ 2-11-2014

By John Gever, Deputy Managing Editor, MedPage Today


In 16-9 vote, the FDA advisory committee assessing NSAID safety said the warning label on naproxen should not be changed to suggest it has a better cardiovascular risk profile than other drugs in this class.

Those voting “No” on the question indicated that the current evidence on naproxen’s safety — much of which was indirect, coming from studies in which it served as a comparator to a coxib drug — did not meet the standards necessary to support label statements.

The panel — comprising members of FDA’s arthritis and risk management committees — split more closely on a question about label information on the duration of NSAID treatment that raises cardiovascular safety risks.

Currently, labels for these drugs say that short-term treatment is relatively safe; however, some recent studies have sown doubt. A total of 14 panel members said the current statement should be reconsidered, while 11 voted No.

However, most of those in the latter camp indicated in post-vote discussion that they believed there is no completely safe dosing period.

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Recent Considerations in Nonsteroidal Anti-inflammatory Drug Gastropathy

By |January 16, 2014|Iatrogenic Injury, NSAIDs|

Recent Considerations in Nonsteroidal Anti-inflammatory Drug Gastropathy

The Chiro.Org Blog


SOURCE:   American Journal of Medicine 1998 (Jul 27);   105 (1B):   31S–38S

Gurkirpal Singh, MD

Department of Medicine, ARAMIS Postmarketing Surveillance Program,
Stanford University of Medicine, Palo Alto, California 94303, USA


Conservative calculations estimate that approximately 107,000 patients are hospitalized annually for nonsteroidal anti-inflammatory drug (NSAID)-related gastrointestinal (GI) complications (internal bleeding) and at least 16,500 NSAID-related deaths occur each year among arthritis patients alone.

The figures for all NSAID users would be overwhelming, yet the scope of this problem is generally under-appreciated (and under-reported!).


In the following year the prestigious New England Journal of Medicine published a similar statement:

“It has been estimated conservatively that 16,500 NSAID-related deaths occur among patients with rheumatoid arthritis or osteoarthritis every year in the United States. This figure is similar to the number of deaths from the acquired immunodeficiency syndrome and is considerably greater than the number of deaths from multiple myeloma, asthma, cervical cancer, or Hodgkin’s disease. If deaths from gastrointestinal toxic effects from NSAIDs were tabulated separately in the National Vital Statistics reports, these effects would constitute the 15th most common cause of death in the United States. Yet these toxic effects remain mainly a “silent epidemic,” with many physicians and most patients unaware of the magnitude of the problem.

Furthermore, these mortality statistics do not include deaths ascribed to the use of over-the-counter NSAIDS.”

Another statement that just happened to catch my eye:

On the basis of these conservative figures and ARAMIS data, the annual number of hospitalizations in the United States for serious gastrointestinal complications is estimated to be at least 103,000. At an estimated cost of $15,000 to $20,000 per hospitalization, the annual direct costs of such complications exceed $2 billion. [14]


Thanks to the American Nutrition Association
for access to this picture!

The Arthritis, Rheumatism, and Aging Medical Information System (ARAMIS) Post-Marketing Surveillance Program (PMS) has prospectively followed patient status and outcomes, drug side effects, and the economic impact of illness for >11,000 arthritis patients at 8 participating institutions in the United States and Canada.

Analysis of these data indicates that:

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