Reclast (zoledronic acid) is intended to be used in the treatment and prevention of osteoporosis, glucocorticoid-induced osteoporosis and Paget’s disease. Each of which have the ability to inhibit the production of bone mass. However, patients who undergo Reclast treatment may significantly increase their risk of developing a number of severe, life-threatening complications. Recent evidence suggests that the prolonged use of Reclast may result in atypical femur fractures and osteonecrosis of the jaw (ONJ). However, the U.S. Food and Drug Administration (FDA) has recently approved of an update to the Reclast label to identify the risk of kidney failure as well.
If you or a loved one has been injured by Reclast, you should contact our lawyersimmediately for a free confidential case evaluation. You may be entitled to compensation for your injuries and we can help.
Reclast Lawsuit Overview
As a product of Novartis, the first formulation of Reclast was introduced to the U.S. market on August 20, 2001. Approval from the FDA made Reclast one of the most popular bisphosphonate medications in America. As a bisphosphonate, Reclast is intended to assist in the treatment of osteoporosis, hypocalcemia, and numerous degenerative bone complications.
The chemical properties of bisphosphonates allow Reclast to treat degenerative bone diseases by aiding in the natural process of homeostasis. Through homeostasis, the skeletal structure is constantly renewing itself to maintain dexterity. During this process, bone naturally diminishes and is kept in balance by osteoblasts that generate new bone. In patients with osteoporosis, bone dexterity is diminished at a more rapid rate than it is generated. As a bisphosphonate, Reclast inhibits the breakdown of bone by preventing the osteoclasts from destroying the bone any further. Subsequently, Reclast promotes the steady growth of bone.
Unfortunately, recent studies suggest that prolonged Reclast treatment may coincide with severe, life-threatening complications. Patients who use Reclast may significantly increase their risk of suffering from atypical femur fractures, ONJ and kidney failure. Studies suggest that the mechanism regarding the association between Reclast and these complications may be directly related to the pharmacodynamics of zoledronic acid. Due to the severity of these complications, patients may contact a lawyer at The Senators (Ret.) Firm, LLP for a free case evaluation of their potential Reclast lawsuit.
Reclast Side Effects
The following is a list of side effects associated with the use of Reclast:
- Kidney (renal) failure
- Low impact femur fractures
- Thigh bone fractures
- Osteonecrosis of the jaw (ONJ)
- Musculoskeletal pain
- Atypical femur fractures
- Subtrochanteric femur fractures
- Femoral shaft fractures
- Thigh deformity
- Leg shortening
Due to the severity of these side effects, patients may contact a lawyer at The Senators (Ret.) Firm, LLP for a free case evaluation of their potential Reclast lawsuit.
JAMA Study Reveals Association Between Bisphosphonates and Unusual Bone Fractures
On February 22, 2011, The Journal of the American Medical Association (JAMA), published an article titled “Long-Term Use of Bisphosphonates Increases Risk for Atypical Fractures”. According to this article, bisphosphonates may initiate a suppression of bone remodeling that can potentially and adversely affect bone strength. Subsequently, prescription bisphosphonates may increase the risk of patients experiencing atypical subtrochanteric or femoral shaft fractures. Furthermore, concerns have emerged that these drugs may inhibit bone restructuring, leading to unusual fractures.
In an attempt to examine whether prolonged treatment with bisphosphonates is associated with an increased risk for subtrochanteric or femoral shaft fracture, researchers used a cohort of women 68 years or older from Ontario, Canada, who began treatment with an oral bisphosphonate between April 1, 2002, and March 31, 2008. The women involved in the study were hospitalized with a subtrochanteric or femoral shaft fracture and were matched with up to 5 control participants without such fractures. Reviews of the patients continued until March 31, 2009.
The main analysis evaluated the association between hospitalization for a subtrochanteric or femoral shaft fracture and duration of bisphosphonate therapy. The investigators also studied the association between bisphosphonate use and fractures of the femoral neck or intertrochanteric region. Because fractures in these sites are characteristic of osteoporotic fractures, this secondary analysis was designed to assess the specificity of findings from the primary analysis.
After starting bisphosphonate therapy, 716 women had a subtrochanteric or femoral shaft fracture, and 9723 women had a typical osteoporotic fracture of the intertrochanteric region or femoral neck.
Reclast Kidney Failure
According to an FDA Safety Communication, the agency has approved an update to the drug label for Reclast to better inform healthcare professionals and patients of the risk of kidney (renal) failure. Kidney failure is a rare, but serious, condition associated with the use of Reclast in patients with a history of or risk factors for renal impairment. Cases of acute renal failure requiring dialysis or having a fatal outcome following Reclast use have been reported to FDA.
A January 2009 FDA post-market safety review identified five deaths from acute renal failure following Reclast infusion. Based on that review, the Warnings and Precautions section of the Reclast label was updated in March 2009, with a recommendation to monitor serum creatinine before each dose of Reclast and included reports of renal impairment from clinical studies.
The 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.
Due to the severity of kidney failure, patients may contact a lawyer at The Senators (Ret.) Firm, LLP for a free case evaluation of their potential Reclast lawsuit.
Do I Have a Reclast Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in Reclast lawsuits. We are currently accepting new cases in all 50 states.
Again, if you or a loved one has been injured by Reclast, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.