Reclast Lawyer

FDA Alert: The popular osteoporosis drug Reclast has recently been linked to severe side effects including kidney failure and renal impairment. In response to reports of these adverse events, the FDA is requiring that Reclast warning labels be revised to include information about this increased risk. The Reclast lawyers at Schmidt & Clark, LLP are currently investigating potential lawsuits nationwide on behalf of those injured by Reclast side effects.

Free Reclast Lawsuit Case Evaluation: If you or a loved one has been injured by Reclast side effects, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.

What’s the problem?

September 1, 2011 - The U.S. Food & Drug Administration (FDA) today issued a press release notifying healthcare professionals and patients that warning labels for the osteoporosis drug Reclast (zoledronic acid) will be updated to include the risk of kidney failure.

According to the Drug Safety Communication, the administration has received a number of reports of acute renal failure requiring dialysis or having a fatal outcome in Reclast users. The updated labels will contain verbiage stating that Reclast is contraindicated in individuals with creatine clearance less than 35 mL/min and in patients with a history of acute renal impairment. The new label will also recommend that physicians screen patients prior to initiating a regimen of Reclast in order to identify at-risk individuals. Additionally, Novartis is expected to issue a Dear Healthcare Provider letter to inform those in the medical community about this risk.

Individuals at particular risk for developing Reclast-induced kidney failure include those:

• with a history renal impairment;
• who use kidney-damaging (nephrotoxic) or diuretic drugs while simultaneously taking Reclast;
• who are severely dehydrated before or after taking Reclast;
• elderly patients.

Please Note: The updated information about kidney failure is only being made to Reclast labels, although zoledronic acid (the active ingredient in Reclast), which is also sold as Zometa, is FDA-approved for the treatment of cancer-related indications. Zometa labels currently include the risk for renal toxicity in the Warnings and Precautions section of the drug’s labeling.

How Does Reclast Work?

Reclast (zoledronic acid) is a bisphosphonate drug used in the treatment of osteoporosis and Paget’s disease of the bone, a condition involving rapid breakdown of bone combined with abnormal reformation of bone. It is designed to work by binding to cells in the bone, thereby slowing down or eliminating the rate at which they decay. Reclast can also help the body rebuild bone at a more normal rate. Manufactured and marketed by Novartis International AG, Reclast comes in an injectable form and is typically administered by your healthcare professional.

Studies have indicated that Reclast is effective at decreasing alkaline phosphate levels in the blood, which helps to improve osteoporosis and Paget’s disease. A recent study compared a single dose of Reclast with a 30 mg dose of Actonel, a similar drug used in the treatment of Paget’s disease. The results of the study showed that nearly 90 percent of women who took Reclast achieved normal alkaline phosphate levels, compare to less than 60 percent of the test subjects taking Actonel. The study also found that Reclast seemed to work significantly faster than Actonel.

If you are taking Reclast

If you are taking Reclast, or are considering beginning a regimen of Reclast, keep the following points in mind:

• In order to protect your kidneys, it is extremely important that you stay hydrated before and after being administered Reclast.
• During the two weeks after your dose, make sure you get enough calcium and vitamin D. Reclast cannot build bone without calcium and vitamin D, which help to prevent the low blood calcium that can be caused by Reclast.
• For patients suffering from Paget’s disease, your healthcare provider may recommend that you be re-treated with Reclast. This is particularly critical during the weeks following your Reclast dose.

Kidney Failure Explained

In a healthy body, the kidneys cleanse the blood by removing excess fluids, minerals and wastes. They also make hormones to keep the bones strong and blood healthy. But if the kidneys are damaged, harmful wastes can build up, the blood pressure may rise, and your body becomes unable to make enough red blood cells. When this happens, it is called kidney failure. Signs and symptoms of Reclast-induced kidney failure may include (but are not limited to):

• swelling, especially in the legs and feet
• little or no urine output
• severe thirst
• dry mouth
• rapid heart rate
• feeling dizzy when you stand up
• loss of appetite
• nausea
• vomiting
• feeling confused, anxious and restless, or sleepy
• pain on one side of the back, just below the rib cage and above the waist (flank pain)

Treating Kidney Failure

Once the cause of kidney failure is identified, the goal of treatment typically involves restoring kidney function and preventing fluid and waste from building up in the body while the kidneys heal. Your doctor will limit the amount of liquid you consume to the amount of urine your body is able to expel. Your diet will be strictly regulated to reduce the buildup of toxins normally handled by the kidneys. Typically, a patient recovering from kidney failure will require a diet that is high in carbohydrates and low in protein, salt and potassium.

Do You Have a Reclast Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Reclast lawsuits. We are handling individual litigation nationwide and currently accepting new Reclast injury cases in all 50 states.