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Reclast (zoledronic acid) is an intravenous (injected) bisphosphonate drug manufactured by Novartis Pharmaceuticals that is prescribed for women for the prevention and treatment of postmenopausal osteoporosis. The drug is intended to reduce the risk of spinal or hip fractures. Reclast has been on the U.S. market since it was approved for sale by the FDA in 2001.
In January 2011, Novartis Pharmaceuticals modified the Full Prescribing Information for Reclast to include a warning on atypical femoral fractures that may result from use of bisphosphonate drugs. The warning includes a very concerning statement indicating that “atypical femur fractures most commonly occur with minimal or no trauma to the affected area.”
The Full Prescribing Information for Reclast also includes warnings regarding the possible development of osteonecrosis of the jaw from taking bisphosphonates as well as the possibility of renal impairment from taking Reclast.
On September 1, 2011, the FDA updated the Reclast drug label to include a new warning on the increased risk of kidney (renal) failure for patients taking the medication. This update comes after cases of acute renal failure were reported to the FDA as a result of using Reclast. The new drug label provides healthcare providers with instructions on how to prescribe and monitor the use of Reclast in patients.
Certain risk factors increase the likelihood of developing kidney (renal) failure as a result of taking Reclast. These risk factors include underlying renal impairment, use of nephrotoxic medications while on Reclast, or severe dehydration occurring before or after Reclast is administered. The risk of renal failure as associated with this drug also increases with age.
The change to the label follows a review conducted by the FDA in April 2011 indicating eleven deaths from acute renal failure and nine cases of renal injury after the infusion of Reclast in these patients. After reviewing these reports received by the agency through its Adverse Event Reporting System, the FDA decided to include the renal risk factors associated with Reclast on the drug label.
If you or a loved one have taken a bisphosphonate drug such as Reclast, please contact our firm at 1-800-247-1623 or email@example.com for a free consultation to discuss your legal rights.
Reclast® is a registered trademark of Novartis AG and is used for informational and product identification purposes only.