Written by Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
On April 14, 2016, the FDA issued a label revision for Reclast (zoledronic acid) Injection. This drug belongs to the bisphosphonate derivative class of drugs, and is manufactured by Novartis Pharmaceuticals Corporation.
Though previous Reclast labels warned that "Osteonecrosis of the jaw" was a possible side effect, this most recent label change includes a new warning for "Osteonecrosis of other bones." As stated on the FDA label (accessed on 4/18/16), "other bones" include the "femur, hip, knee, ankle, wrist and humerus."
Though enough cases concerning osteonecrosis of the aforementioned bones have been reported to warrant a change in the drug label, the text states that "causality has not been determined in the population treated with Reclast."
We will continue to monitor medical literature for further developments regarding additional FDA-issued label revisions for Reclast, and other bisphosphonate drugs.
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