The priorities of the FDA seem more than a little confusing at times. On July 9th, the FDA strengthened a prior warning regarding non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil) and naproxen (Aleve), along with numerous prescription drugs used to treat pain and arthritis. These over-the-counter and prescription drugs can significantly increase the risk of heart attack and stroke. This does not apply to aspirin. The following is a summary of the FDA warning:

  • NSAIDs increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease.
  • The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID.
  • The risk increases with longer use.
  • The risk appears greater at higher doses.
  • Patients with heart disease or risk factors have a greater risk.
  • There is an increased risk of heart failure with NSAID use.

This comes after years of undeniable evidence. Prior studies have shown that there is an overall risk of death or recurrent heart attack of 1.5 times, with certain NSAIDs having over 3 times the risk. A study in the British Medical Journal showed that ibuprofen use was associated with 1.6 times the risk of heart attack and over 3 times the risk of stroke!

Why has it taken so long to get the word out about these medications that have been taken by nearly everyone? The sheer numbers are mind-boggling.

Yet, the FDA was quick to issue strong warnings regarding testosterone replacement therapy based on two poorly done studies that the FDA itself had previously rejected due to multiple flaws and weaknesses (see FDA Rejects Citizens Petition). They seem to ignore the fact that years of medical literature support the health benefits of testosterone replacement when used appropriately.

Studies continue to be published that contradict FDA warnings on testosterone. The latest large-scale study published in the Mayo Clinic Proceedings refutes the FDA’s assertion that testosterone increases the risk of blood clots (VTE). See “Study Findings Don’t Support FDA’s Testosterone Therapy-VTE Warning.

At the same time, an April 2015 study in Rheumatology showed that NSAIDs increase the risk of blood clots by 1.8 times.

Perspective: It’s clear that these common over-the-counter and prescription NSAIDs cause far more heart attacks and strokes than testosterone. In fact, ongoing studies fail to show any increased risk of heart attacks with testosterone.

It is hard to imagine what the motives of the FDA advisory panel might be when considering these disparities. I, for one, just don’t get it.

For more information regarding the controversy surrounding testosterone therapy, see:

Caution: FDA Warnings Can Be Hazardous to Your Health!

FDA Warning on Testosterone Contradicts Medical Experts

As always, if you have any questions please feel free to contact me at (720) 387-3681.