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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.

Vertebral artery strains during high-speed, low amplitude cervical spinal manipulation.

By |November 23, 2012|Research|

J Electromyogr Kinesiol. 2012 Oct;22(5):740-6. doi: 10.1016/j.jelekin.2012.03.005. Epub 2012 Apr 5.

Herzog W, Leonard TR, Symons B, Tang C, Wuest S.

Abstract

Spinal manipulative therapy (SMT) has been recognized as an effective treatment modality for many back, neck and musculoskeletal problems. One of the major issues of the use of SMT is its safety, especially with regards to neck manipulation and the risk of stroke. The vast majority of these accidents involve the vertebro-basilar system, specifically the vertebral artery (VA) between C2/C1. However, the mechanics of this region of the VA during SMT are unexplored. Here, we present first ever data on the mechanics of this region during cervical SMT performed by clinicians. VA strains obtained during SMT are significantly smaller than those obtained during diagnostic and range of motion testing, and are much smaller than failure strains. We conclude from this work that cervical SMT performed by trained clinicians does not appear to place undue strain on VA, and thus does not seem to be a factor in vertebro-basilar injuries.

Crown Copyright © 2012. Published by Elsevier Ltd. All rights reserved.

The October 2012 issue is devoted to the study of spinal manipulation.

Court finds chiropractic negligence in manipulation

By |January 21, 2010|Legal Action|

Source Tom Blackwell, National Post

A new court ruling has again called into question a widely used but controversial chiropractic treatment, concluding that a Newfoundland practitioner made a patient deaf in one ear and caused other debilitating injuries by performing a neck manipulation on him.

The judge in the civil suit found the chiropractor negligent and will decide later what compensation to award Abe Gallant, who says he had to leave his $80,000-a-year job because of the damage.

The decision follows a series of public inquiries and inquests that have blamed cervical manipulation for strokes, some of them fatal, and the filing of a $500-million class action suit in Alberta that targeted the allegedly dangerous chiropractic therapy. (more…)