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| Other drug names: | A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0-9 |
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[Posted 11/12/2008] FDA issued an update to the Agency's review of safety data regarding the potential increased risk of atrial fibrillation in patients treated with a bisphosphonate drug. Bisphosphonates are a class of drugs used primarily to increase bone mass and reduce the risk for fracture in patients with osteoporosis, slow bone turnover in patients with Paget's disease of the bone, and to treat bone metastases and lower elevated levels of blood calcium in patients with cancer. FDA reviewed data on 19,687 bisphosphonate-treated patients and 18,358 placebo-treated patients who were followed for 6 months to 3 years. The occurrence of atrial fibrillation was rare within each study, with most studies containing 2 or fewer events. Across all studies, no clear association between overall bisphosphonate exposure and the rate of serious or non-serious atrial fibrillation was observed. Additionally, increasing dose or duration of bisphosphonate therapy was not associated with an increase rate of atrial fibrillation. Healthcare professionals should not alter their prescribing patterns for bisphosphonates and patients should not stop taking their bisphosphonate medication. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#bisphosphonates2, and http://www.fda.gov/cder/drug/early_comm/bisphosphonates_update_200811.htm. |
Zoledronic acid (Reclast) is used to treat osteoporosis (condition in which the bones become thin and weak and break easily) in women who have undergone menopause ('change of life,' end of regular menstrual periods). Zoledronic acid (Reclast) is also used to treat Paget's disease of bone (a condition in which the bones are soft and weak and may be deformed, painful, or easily broken). Zoledronic acid (Zometa) is used to treat high levels of calcium in the blood that may be caused by certain types of cancer. Zoledronic acid (Zometa) is also used along with cancer chemotherapy to treat bone damage caused by multiple myeloma [cancer that begins in the plasma cells (white blood cells that produce substances needed to fight infection)] or by cancer that began in another part of the body but has spread to the bones. Zoledronic acid (Zometa) is not cancer chemotherapy, and it will not slow or stop the spread of cancer. However, it can be used to treat bone disease in patients who have cancer. Zoledronic acid is in a class of medications called bisphosphonates. It works by slowing bone breakdown, increasing bone density (thickness), and decreasing the amount of calcium released from the bones into the blood.
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Zoledronic acid comes as a solution (liquid) to inject into a vein over at least 15 minutes. It is usually injected by a health care provider in a doctor's office, hospital, or clinic. When zoledronic acid injection is used to treat high blood levels of calcium caused by cancer it is usually given as a single dose. A second dose may be given at least 7 days after the first dose if blood calcium does not drop to normal levels or does not remain at normal levels. When zoledronic acid injection is used to treat bone damage caused by multiple myeloma or cancer that has spread to the bones, it is usually given once every 3-4 weeks. When zoledronic acid injection is used to treat osteoporosis, it is usually given once a year. When zoledronic acid is used to treat Paget's disease of bone, it is usually given as as a single dose, but additional doses may be given after some time has passed.
Your doctor may prescribe or recommend a calcium supplement and a multivitamin containing vitamin D to take during your treatment. You should take these supplements every day as directed by your doctor.Tell your doctor if there is any reason that you will not be able to take these supplements during your treatment.
You may experience a reaction during the first few days after you receive a dose of zoledronic acid injection. Symptoms of this reaction may include flu-like symptoms, fever, headache, and bone or muscle pain. These symptoms may begin during the first 3 days after you receive a dose of zoledronic acid injection and may last 3-14 days. Your doctor may recommend that you take a nonprescription pain reliever/fever reducer after you receive zoledronic acid injection to prevent or treat these symptoms.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Before receiving zoledronic acid injection,
Unless your doctor tells you otherwise, continue your normal diet. Eat and drink normally on the day(s) you receive a dose of zoledronic acid. Be sure to drink at least 2 glasses of water or another liquid within a few hours before you receive zoledronic acid.
If you miss an appointment to receive a zoledronic acid infusion, call your doctor as soon as possible.
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Zoledronic acid may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:
Zoledronic acid may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].
Your doctor will store this medication in his or her office and give it to you as needed.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to zoledronic acid.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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Last Revised - 05/01/2008

AHFS® Consumer Medication Information. © Copyright, 2009. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
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Page last updated: 16 June 2009 |