The popular osteoporosis medication Reclast has recently been associated with severe kidney impairment and acute renal failure. The U.S. Food & Drug Administration (FDA) has issued a Drug Safety Communication stating that it is requiring Reclast warning labels to be updated to include information about this risk. The Reclast lawyers at Schmidt & Clark, LLP are currently investigating potential lawsuits nationwide on behalf of individuals injured by Reclast side effects.
What’s the problem?
On September 1, 2011, the FDA issued a press release stating that Reclast labels will be updated to include information regarding the risk of kidney impairment and acute renal failure. The administration cited a number of cases of these types of adverse events in Reclast users. The new labels will contain verbiage stating that Reclast is contraindicated in patients with creatinine clearance less than 35 mL/min or in patients with evidence of acute renal impairment. According to the FDA press release:
Risk factors for developing renal 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.
It is important to note that the updated labeling changes will only be applied to Reclast, despite the fact that zoledronic acid, which is the active ingredient found in Reclast, is also sold as Zometa and marketed for the treatment of cancer-related indications. Renal toxicity is currently cited in the Warnings and Precautions section of the Zometa label. Dose reductions for Zometa are provided for individuals suffering from kidney impairment.
Reclast Kidney Failure
Acute renal failure occurs when your kidneys stop working. Your kidneys remove waste products and help balance water, salt, and other minerals in your blood. When your kidneys fail, waste products, fluids, and electrolytes cannot be processed and build up in the body. When this occurs, potentially fatal health issues can ensue. Signs and symptoms of Reclast-induced kidney failure may include (but are not limited to):
- decreased urine output, although occasionally urine output remains normal
- fluid retention, causing swelling in your legs, ankles or feet
- shortness of breath
- seizures or coma in severe cases
- chest pain or pressure
Individuals who have serious, long-term health problems are more likely than other people to have kidney damage from drugs like Reclast. In addition to Reclast, other medications that can sometimes cause harm to the kidneys include:
- antibiotics, such as gentamicin and streptomycin
- pain medications, such as aspirin and ibuprofen
- certain blood pressure medications, such as ACE inhibitors
- the dyes used in some X-ray tests
Side Effects of Reclast
In addition to the risk of kidney impairment and renal failure, Reclast may also cause the following side effects:
- urinating less than usual or not at all
- muscles spasms
- numb or tingly feeling (especially around the mouth)
- body aches
- flu-like symptoms
- pale skin
- easy bruising
- unusual weakness
- severe joint, bone or muscle pain
Before Taking Reclast
Prior to undergoing treatment with Reclast, you should tell your doctor or pharmacist if you are allergic to it or other bisphosphonates, and if you have trouble breathing after taking aspirin. Reclast may contain inactive ingredients, which can cause unanticipated allergic reactions and other problems. You are advised to consider alternative methods of treatment if you have a medical history of:
- kidney problems
- low calcium levels in the blood
- problems taking calcium/vitamin D supplements
- recent or planned dental surgery (e.g., tooth removal)
- certain gut problems (malabsorption, surgery on the small intestine)
- treatment with zoledronic acid (e.g., for cancer)
- parathyroid/thyroid cancer
Additionally, do not use Reclast under any circumstances if you are pregnant or planning to become pregnant. Reclast could cause harm to an unborn baby if exposed to the drug in utero. Always use an effective form of birth control when taking Reclast, and consult your healthcare provider immediately if you become pregnant during the course of treatment.