As I write in a recent blog post titled ‘Alert: New Life-Threatening Reclast Side Effects', the most commonly reported Reclast side effects – ranging from joint and bone pain to osteonecrosis of the jaw – pale in comparison to the most recent concerns regarding kidney impairment and failure.
In the same post I quote an article about a US consumer group urging the FDA to warn physicians and patients of the dangerous and sometimes life-threatening renal toxicity associated with Reclast.
Per the FDA’s own posting this September 1st,
“FDA continued to note reports of renal failure to the Agency's Adverse Event Reporting System (AERS) after the March 2009 label revision. A follow-up review in April 2011 showed an additional 11 cases of fatal acute renal failure and nine cases of renal injury requiring dialysis after Reclast infusion.” 1
So what has changed? Not much, except that the risk factors which could lead to kidney failure will be added to the drug’s label from now on. Because in view of this possible side effect, new risk guidelines to screen patients before administering Reclast have been established “to reduce the likelihood of adverse events occurring and help ensure the safe use of Reclast.”1
Notice that the word “reduce” is used instead of “eliminate”. Not very comforting, to say the least.
New Label Warnings Open to Interpretation
In an attempt to identify risk factors that cause nephrotoxicity, the brand new guidelines establish testing for creatinine clearance, a kidney function marker, both before and after the Reclast infusion “to assess how well your kidneys are functioning.”1
It also advises physicians to:
“Continue to screen patients prior to each administration of Reclast to identify those with underlying acute or chronic renal impairment, advanced age, or dehydration. Patients with underlying renal impairment appear to be at highest risk for kidney failure. Reclast should be used with caution in this population.” 1
Doesn’t it make you wonder how a health practitioner would interpret “use with caution?” But why struggle with the doubt, if there is a…
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