"Sept. 1, 2011 -- The FDA warns that the osteoporosis drug Reclast (zoledronic acid) raises the risk of kidney failure.
The warning is targeted at patients who already suffer from kidney impairment. It's also aimed at those who are tak"...
Zometa Patient Information including How Should I Take
In this Article
- What is zoledronic acid (Zometa)?
- What are the possible side effects of zoledronic acid (Zometa)?
- What is the most important information I should know about zoledronic acid (Zometa)?
- What should I discuss with my healthcare provider before receiving zoledronic acid (Zometa)?
- How is zoledronic acid given (Zometa)?
- What happens if I miss a dose (Zometa)?
- What happens if I overdose (Zometa)?
- What should I avoid while receiving zoledronic acid (Zometa)?
- What other drugs will affect zoledronic acid (Zometa)?
- Where can I get more information?
What should I discuss with my healthcare provider before receiving zoledronic acid (Zometa)?
You should not receive this medication if you are allergic to zoledronic acid or similar medicine such as alendronate (Fosamax), etidronate (Didronel), ibandronate (Boniva), pamidronate (Aredia), risedronate (Actonel), or tiludronate (Skelid).
You should also not receive zoledronic acid if you have:
- low levels of calcium in your blood; or
- if you are pregnant or breast-feeding.
Zometa and Reclast are two different brands of zoledronic acid. You should not be treated with Reclast if you are already receiving Zometa. Before receiving a Reclast injection, tell your doctor if you are already being treated with Zometa.
Do not use Reclast if you have severe kidney disease.
To make sure you can safely use zoledronic acid, tell your doctor if you have any of these other conditions:
- aspirin-sensitive asthma;
- a thyroid or parathyroid disorder;
- malabsorption syndrome (an inability to absorb food and nutrients properly);
- a history of surgical removal of part of your intestine;
- bone cancer;
- kidney disease; or
- if you are dehydrated.
Your doctor may recommend you have a dental exam for preventive tooth and gum care before you start your treatment with zoledronic acid. This is especially important if you have cancer, if you are undergoing chemotherapy or using steroids, or if you have poor dental health.
Some people using medicines similar to zoledronic acid have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums.
You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and dental surgery or pre-existing dental problems.
FDA pregnancy category D. Do not use zoledronic acid if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.
Zoledronic acid can pass into breast milk and may harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.
Serious side effects on the kidneys may be more likely in older adults using zoledronic acid.
How is zoledronic acid given (Zometa)?
Zoledronic acid is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. Zoledronic acid must be given slowly, and the IV infusion can take at least 15 minutes to complete.
Zoledronic acid is sometimes given only once per year. Follow your doctor's instructions.
Drink at least 2 glasses of water within a few hours before your injection to keep from getting dehydrated.
Your doctor may want you to take a calcium and/or vitamin D supplement while you are being treated with zoledronic acid. Carefully follow your doctor's instructions about the type and strength of calcium to take.
To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Your kidney function may also need to be tested. You may not need to use zoledronic acid for longer than 3 to 5 years if you use it for osteoporosis. Visit your doctor regularly.
Additional Zometa Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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