Reclast Side Effects. Did you suffer a serious side effect from Reclast ( Zoledronic Acid )? Reclast is a bisphosphonate sold by Novartis Pharmaceuticals Corporation. The drug is administered intravenously once a year, a procedure that takes about 15 minutes. Outside the U.S., Reclast is sold under the name Aclasta. Novartis Oncology also markets Zoledronic Acid under the name Zometa to prevent cancer from spreading to the bone, and other cancer-related complications.
Over the past several years, Reclast has been associated with a number of side effects, including:
- Femur Fractures
- Osteonecrosis of the Jaw/Dead Jaw Syndrome
- Atrial Fibrillation
- Severe Musculoskeletal Pain
- Kidney Failure
If you or a loved one suffered one of these Reclast side effects, you may be entitled to compensation for medical bills, lost wages, pain and suffering, and other damages. Our Reclast side effects lawyers are currently offering free case evaluations to victims of these injuries. We urge you to contact us today to protect your legal rights.
Reclast ( Zoledronic Acid ) and Atypical Femur Fractures
In 2010, the American Society of Bone and Mineral Research Femoral Fracture Task Force recommended that US health regulators rewrite the warning labels for bisphosphonates because of their possible association with atypical femur fractures. The task force recommendation was prompted by its finding that the bone drugs might be linked to the rare, but serious, type of thigh bone fracture. In conducting the study, the task force looked at 310 cases of atypical femur fractures and found that in the majority of cases (291), the patients had been taking bisphosphonates. The majority of patients had been taking the drugs for more than five years. Many of the patients were also taking glucocorticoids, which can lower bone density and increase fracture risks. The report noted that more than half of the patients studied experienced groin or thigh pain for a period of weeks or months before their fractures. Following the publication of that study, the FDA ordered the manufacturers of bisphosphonates, including Reclast, to add information about atypical femur fractures to the “Warning and Precautions” sections of their labels. The new information addresses two types of fractures. Atypical subtrochanteric femur fractures are fractures in the bone just below the hip joint. Diaphyseal femur fractures occur in the long part of the thigh bone. These fractures are very uncommon and appear to account for less than 1% of all hip and femur fractures overall.
Reclast ( Zoledronic Acid ) and ONJ
Osteonecrosis of the jaw (ONJ) or dead jaw syndrome is an excruciatingly painful and disfiguring bone disease. ONJ is a condition in which the bone tissue in the jaw fails to heal after minor trauma such as a tooth extraction, causing the bone to be exposed. The exposure can eventually lead to infection and fracture and may require long-term antibiotic therapy or surgery to remove the dying bone tissue.
An increased incidence of ONJ has been associated with the use of high dosages of bisphosphonates required by some cancer treatment regimens. The disease has also been seen in post-menopausal women being treated with drugs for osteoporosis. Signs and symptoms of ONJ may include: jaw pain, swelling of the gums, loose teeth, drainage, exposed jaw bone, numbness, or a feeling of heaviness in the jaw. In 2005, the U.S. Food & Drug Administration (FDA) ordered the makers of bisphosphonates, including Reclast, to add warnings about ONJ to their labels.
Reclast ( Zoledronic Acid ) and Atrial Fibrillation
In 2008, a study conducted by researchers at the University of Washington found that treatment with the bisphosphonate Fosamax could double the risk of atrial fibrillation. Atrial fibrillation – a chronic, irregular heartbeat – causes fatigue, dizziness and fainting, but it isn’t life-threatening. Women who had taken the drug had an 86 percent higher risk of atrial fibrillation than those who never took Fosamax, the study found. But these results were far from conclusive, doctors say. Fosamax accounted for 3 percent of the atrial fibrillation cases, and 97 percent were the result of other causes. The researchers said their findings showed a need for more study on this potential Fosamax side effect.
A study published in 2007 in the May 7 issue of the New England Journal of Medicine also found that bisphosphonates appeared to increase the risk of irregular heartbeats in some older women. Researchers conducting a review of a 1997 study of postmenopausal women on bisphosphonates found that there appeared to be 50 percent more risk of the heart rhythm irregularity in women who took the drugs than among those who didn’t take it. About half of the 6,459 women took Fosamax, and 47 developed atrial fibrillation, compared to just 31 cases among the other women.
Bisphosphonates and Severe Musculoskeletal Pain
In January 2008, the FDA warned that use of bisphosphonates, including Reclast, had been linked to severe and sometimes incapacitating bone, joint, and muscle (musculoskeletal) pain. The agency said it was concerned that the association between bisphosphonates and severe musculoskeletal pain may be overlooked by healthcare professionals, delaying diagnosis, prolonging pain and impairment, and necessitating the use of analgesics.
According to the FDA warning, the severe musculoskeletal pain associated with bisphosphonates may occur within days, months, or years after starting a bisphosphonate. Some patients have reported complete relief of symptoms after discontinuing the bisphosphonate, whereas others have reported slow or incomplete resolution. The risk factors for and incidence of severe musculoskeletal pain associated with bisphosphonates are unknown. The FDA recommended that healthcare professionals should consider whether bisphosphonate use might be responsible for severe musculoskeletal pain in patients who present with these symptoms and consider temporary or permanent discontinuation of the drug.
Reclast ( Zoledronic Acid ) and Kidney Failure
In September 2011, the FDA updated the Reclast label to include additional information about its association with kidney failure. According to the FDA, the revised drug label will enhance the safe use of Reclast by providing healthcare professionals updated instructions for prescribing and patient monitoring.
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 kidney failure requiring dialysis or having a fatal outcome following Reclast use have been reported to FDA. Risk factors for developing kidney failure include underlying moderate to severe renal impairment, use of kidney-damaging (nephrotoxic) or diuretic medications at the same time as Reclast, or severe dehydration occurring before or after Reclast is given. The risk of developing renal failure in patients with underlying renal impairment also increases with age.