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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 01/07/2008] FDA informed healthcare professionals and patients of the possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain in patients taking bisphosphonates. Although severe musculoskeletal pain is included in the prescribing information for all bisphosphonates, the association between bisphosphonates and severe musculoskeletal pain may be overlooked by healthcare professionals, delaying diagnosis, prolonging pain and/or impairment, and necessitating the use of analgesics. The severe musculoskeletal pain may occur within days, months, or years after starting a bisphosphonates. Some patients have reported complete relief of symptoms after discontinuing the bisphosphonate, whereas others have reported slow or incomplete resolution. The risk factors for and incidence of severe musculoskeletal pain associated with bisphosphonates are unknown. Healthcare professionals should consider whether bisphosphonate use might be responsible for severe musculoskeletal pain in patients who present with these symptoms and consider temporary or permanent discontinuation of the drug. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Bisphosphonates and http://www.fda.gov/cder/drug/infopage/bisphosphonates/default.htm. [Posted 10/01/2007] FDA issued an early communication about the ongoing review of new safety data regarding the association of atrial fibrillation with the use of bisphosphonates. 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, treat bone metastases, and lower elevated levels of blood calcium in patients with cancer. FDA reviewed spontaneous postmarketing reports of atrial fibrillation reported in association with oral and intravenous bisphosphonates and did not identify a population of bisphosphonate users at increased risk of atrial fibrillation. In addition, as part of the data review for the recent approval of once-yearly Reclast for the treatment of postmenopausal osteoporosis, FDA evaluated the possible association between atrial fibrillation and the use of Reclast (zoledronic acid). Most cases of atrial fibrillation occurred more than a month after drug infusion. Also, in a subset of patients monitored by electrocardiogram up to the 11th day following infusion, there was no significant difference in the prevalence of atrial fibrillation between patients who received Reclast and patients who received placebo. Upon initial review, it is unclear how these data on serious atrial fibrillation should be interpreted. Therefore, FDA does not believe that healthcare providers or patients should change either their prescribing practices or their use of bisphosphonates at this time. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Bisphosphonates and http://www.fda.gov/cder/drug/early_comm/bisphosphonates.htm. |
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 is used to treat high levels of calcium in the blood that may be caused by certain types of cancer. Zoledronic acid 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 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 and decreasing the amount of calcium released from the bones into the blood.
Zoledronic acid comes as a solution (liquid) to infuse (inject slowly) intravenously (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 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 remain at normal levels. When zoledronic acid 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.
Your doctor will prescribe a calcium supplement and a multivitamin containing vitamin D to take during your treatment. You should take these supplements every day.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Before taking zoledronic acid,
Unless your doctor tells you otherwise, continue your normal diet.
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. The following symptoms are uncommon, but if you experience any of them, 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 -
10/01/2007
Last Reviewed -
04/01/2005
The MedMaster™ Patient Drug Information database provides information copyrighted by the American Society of Health-System Pharmacists, Inc., Bethesda, Maryland Copyright© 2008. All Rights Reserved.
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Page last updated: 17 April 2008 |