Kidney Damage: Link Has Been Made With an Osteoporosis Drug

There have been 16 deaths thus far relating to kidney damage, with a potential connection to a commonly prescribed osteoporosis medication

The United States Food and Drug Administration (FDA), in September 2011, began notifying physicians and patients of an update to the label for Reclast (zoledronic acid) addressing the potential risk of kidney failure. Cases have been reported of acute renal failure. This condition normally requires kidney dialysis (an artificial process of removing waste from blood when the kidneys can no longer function in this manner) and in some cases resulting in death.

Now, “Reclast is contraindicated for patients with specific conditions, see below FDA website screenshot:

Screenshot from FDA website

Physicians must screen patients prior to prescribing Reclast as to identify what patients are contraindicated (unable to take) the drug. This is a result of a January 2009 report of the FDA showing 5 deaths as a result of kidney failure, connected with this medication. After April 2011, 11 more deaths had been reported. There are no published reports on the number of kidney failure cases that do not result in death and instead require dialysis. This metric is difficult to track, as there are other risk factors that can contribute to kidney failure and the level of inquisition with regards to causes may not be as rigorous if death is not the result.

 

The risk factors for developing renal failure include the following:

  1. The use of kidney-damaging (nephrotoxic) or diuretic medications at the same time as Reclast, or severe dehydration occurring before or after Reclast is administered.
  2. The risk of developing renal failure in patients with underlying renal impairment also increases with age.

 

Symptoms of Renal Failure:

  • Nausea
  • Urination while sleeping
  • Vomiting and/or diarrhea, which may lead to dehydration
  • Blood in the urine (usually showing a darker color of urine)
  • Difficulty urinating
  • Infrequent amounts of urination, typically large quantities
  • More frequent urination, or in greater amounts than usual, with pale urine

 

Healthcare professionals and patients are asked to report any adverse effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

Source:

FDA

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