September 1, 2011 — The FDA has recently released a Drug Safety Communication notifying the public about an update to the drug label of Reclast (generic: zoledronic acid), the osteoporosis medication administered through injection. Reclast has been linked to higher risks of kidney failure, which have required dialysis or even caused death.
Reclast: An Overview
Manufactured by Novartis, Reclast was approved by the FDA in April 2007 to prevent and treat osteoporosis. Reclast belongs to a drug class known as bisphosphonates, drugs that inhibit the mineralization or resorption of the bone. Reclast is administered in a single dose every one to two years through a 15-minute infusion that goes into a vein of the body.
While it is primarily prescribed to postmenopausal women to reduce the chance of hip or spinal fractures, men may also take Reclast to increase bone mass during osteoporosis. It is also prescribed to both men and women to treat Paget’s disease of the bone, or to patients who have taken corticosteroid (steroid hormone) medications for at least one year.
Recently, however, the FDA warns that Reclast has been linked to rare, but serious kidney failure.
Those most at risk of developing kidney (renal) failure include patients who already suffer from kidney impairment or kidney disease, patients who use kidney-damaging (nephrotoxic) or diuretic medications at the same time as Reclast, or patients who experience dehydration occurring before or after Reclast infusions. The risk of kidney failure also increases with age.
Signs and Symptoms of Kidney Failure
Reclast infusions have been associated with heightened risks of kidney injury and kidney failure. Acute kidney failure, also known as renal failure, is the sudden loss of the ability of the kidneys to remove waste and concentrate urine without losing electrolytes. The symptoms of kidney failure include:
- Fluid retention
- Generalized swelling (usually of the ankles, feet or legs)
- Blood stool
- Breath odor or metallic taste in mouth
- Bruising easily
- Changes in mood
- Decreased appetite
- Decreased sensation (especially in the feet or hands)
- Drowsiness or fatigue
- High blood pressure
- Shortness of breath
- Nausea or vomiting
- Persistent hiccups
- Prolonged bleeding
- Chest pain or pressure
- Slow, sluggish movements (lethargy)
- Change in urination (decrease in amount, excessive urination at night, and/or complete stop of urination)
Due to the severity of these symptoms, Reclast patients may want to contact a Reclast lawyer or attorney with The Schmidt Firm, PLLC to discuss the potential for a Reclast lawsuit.
FDA Reclast Study
In January 2009, the FDA conducted a post-market safety review of Reclast infusions. The review identified five deaths associated with acute kidney failure following Reclast use. There were an additional 24 reports of kidney impairment.
At the time, the Warnings and Precautions section of the drug label was updated to include data on acute kidney failure. Additionally, the FDA continued to monitor adverse event reports and encouraged doctors to monitor their patients’ kidney functions before and after Reclast infusions.
A follow up review in April 2011 linked 11 more kidney failure deaths with Reclast infusions. Nine other cases of kidney injury required dialysis.
Because of these numbers, the FDA is updating the Reclast label again to reflect the danger of kidney failure. The label will state Reclast use is not recommended for patients who have creatinine clearance less than 35 mL/min or have a history of kidney failure. The label also recommends doctors screen patients prior to recommending the drug, in order to identify at-risk patients.
These recent label changes are being made to Reclast only, even though zoledronic acid is also sold under the brandname of Zometa. Zometa is approved to treat cancer-related conditions.
Bisphosphonates and Risks of Fractures and Jaw Deterioration
In 2010, Reclast and other bisphosphonates were linked to increased risks of rare femur and thigh fractures, as well as deterioration of the jaw.
As a result, the FDA is asking two advisory panels to convene in a joint meeting on Friday, September 9, 2011 in Maryland to discuss and make recommendations on bisphosphonate medication usage. The FDA estimates that approximately 4 million women use bisphosphonates — including Reclast, Fosamax, Actonel and Boniva.
Based upon the comprehensive review of medical evidence, the panels will discuss if the drugs are safe and effective in long-term use. The panels may recommend requiring women who use the bone drugs to take “drug holidays,” or breaks from the drugs, due to the risks of rare, but serious side effects.
Bisphosphonates have been linked to unusual (atypical) breaks in the femur or thigh, as well as death or deterioration of the jaw, or osteonecrosis.
Because the risk of fracture or osteonecrosis may be linked to the length of time the drug is taken, the panel may discuss whether a ban on long-term use is necessary.
In a recent review article, University of Washington professor Dr. Susan M. Ott said:
“In my opinion, after five years in most cases (bisphosphonates) ought to be stopped. . . The longest anybody could have taken this drug is 15 years now. It’s an ongoing experiment, and there are a few million women in the country who are participating in it. I keep wanting to say, ‘You’re all guinea pigs after five years because that’s when the studies stopped.’ ”
The FDA is expected to issue a report Wednesday, September 14, 2011 with the panels’ findings.
What Is Osteoporosis?
Osteoporosis is the thinning and weakening of bones that increases the chance of having a broken bone. It is the most common type of bone disease, with researchers estimating that one out of 5 American women over the age of 50 has osteoporosis.
Osteoporosis occurs when the body fails to create new bone, while old bone gets reabsorbed by the body. As a result, bones become more brittle and are prone to breaks.
Women over the age of 50 and men over the age of 70 have the greatest risk of developing osteoporosis. Osteoporosis is often linked to older women because the leading cause of osteoporosis is a drop in estrogen, which occurs at the time of menopause. Men over the age of 70 often experience a drop in testosterone, which has the same effect as a drop in estrogen for women.
Osteoporosis treatment often requires a combination between drug therapy and a change in lifestyle. Comprehensive osteoporosis treatment includes an increased diet of calcium and vitamin D, and constant exercise — which can improve bone health, increase muscle strength, coordination and balance.