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September 1, 2011 — While previous warnings from the FDA have linked the osteoporosis medication Reclast (zoledronic acid) to increased risks of femur/thigh fractures and jaw deterioration, new research from the FDA suggests Reclast may also cause rare, but serious kidney failure in users. This kidney failure may be fatal or require dialysis.

Reclast: An Overview

FDA approved in 2007, Reclast (zoledronic acid) is often prescribed to treat or prevent osteoporosis in post-menopausal women, as it helps to reduce the chance of having a hip or spinal fracture.

Manufactured by Novartis, Reclast is administered through an IV injection every one to two years in a 15-minute infusion. It inhibits the release of calcium from bones and belongs a group of drugs known as bisphosphonates.

Recently, the FDA has linked Reclast to rare, but serious kidney failure that may be fatal or require dialysis. Patients most at risk include those with a history of kidney failure risk factors, or those currently displaying risk factors.

As a result, the FDA is updating Reclast drug labels to recommend Reclast should not be used in patients with creatinine (a breakdown chemical used by the body) clearance less than 35mL/min or in patients with acute kidney impairment. Healthcare professionals should also screen new patients to identify patients who may be at risk of developing kidney failure from Reclast use.

Risk Factors of Reclast Kidney Failure

Risk factors for developing Reclast renal failure include:

  • Underlying kidney failure (moderate to severe)
  • Use of Reclast at the same time as kidney-damaging (nephrotoxic) or diuretic medications
  • Severe dehydration occurring before or after Reclast use
  • Increased age

Symptoms of Reclast Kidney Failure

The FDA has recently linked Reclast to serious and life-threatening kidney failure. The following are signs and symptoms of kidney failure:

  • Decreased urine output
  • No urine output
  • Generalized swelling
  • Nausea
  • Vomiting
  • Decreased appetite
  • Confusion
  • Anxiety
  • Restlessness
  • Lethargy
  • Fatigue
  • Weakness
  • Shortness of breath
  • Increased blood pressure
  • Pain in the abdomen
  • Decreased mental function

Due to the severity of the symptoms associated with Reclast kidney failure, you or somebody you know who took Reclast and developed kidney failure may want to contact a Reclast lawyer or attorney with The Clark Firm to discuss the potential for a Reclast lawsuit.

FDA Study and Warning

As of January 2009, the FDA identified at least five deaths from acute kidney failure following a Reclast infusion. There were also an additional 24 reports of kidney impairment. At the time, the FDA updated the Warning and Precautions section of the Reclast label to reflect clinical study reports of kidney failure. The labels also recommended doctors monitor patients’ kidney functions before and after administering Reclast.

A follow-up review in April 2011 found an additional 11 cases of fatal acute kidney failure associated with Reclast use, as well as nine cases of kidney injury requiring dialysis.

The risk of fatal kidney failure prompted the FDA to once again update the Reclast drug label. Even though zoledronic acid is also marketed as the cancer-treating drug Zometa, only the label on Reclast is being updated. Kidney toxicity is already included in the Zometa label and dose reductions for Zometa are provided for patients with kidney impairment or injury.

Said the FDA about the Reclast drug label update:

“The revised drug label will enhance the safe use of Reclast by providing healthcare professionals updated instructions for prescribing and patient monitoring. The revised label states that Reclast should not be used (is contraindicated) in patients with creatinine clearance less than 35 mL/min or in patients with evidence of acute renal impairment. The label also recommends that healthcare professionals screen patients prior to administering Reclast in order to identify at-risk patients. Healthcare professionals should also monitor renal function in patients who are receiving Reclast.”

Reclast Uses and Treatments

While Reclast is primarily prescribed to post-menopausal women to prevent osteoporosis, Reclast may also be prescribed for other uses, including:

  • Used to treat or prevent osteoporosis in women after menopause. Reclast lowers chances of hip or spinal fractures.
  • Used to increase bone mass in men with osteoporosis.
  • Used to treat or prevent osteoporosis in men or women who use corticosteroid medications for at least one year.
  • Used to treat men or women who have Paget’s disease.

Bisphosphonates and Risks of Fractures and Jaw Deterioration

In 2010, the FDA linked Reclast and other drugs from the bisphosphonate class to increased risks of unusual and rare femur and thigh fractures, as well as jaw deterioration known as osteonecrosis.

Because approximately 4 million women use bisphosphonates — including Reclast, Fosamax, Actonel and Boniva — the FDA asked two advisory panels to convene on Friday, September 9, 2011 to discuss and make recommendations on the safety and effectiveness of bisphosphonates.

Since the risk of fracture or osteonecrosis may be linked to the length of time women take bisphosphonates, the panel may recommend a ban on long-term use of the drugs. They may also recommend “drug holidays,” or breaks from the drugs, because of the risk of rare, but serious side effects.

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