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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/Safety/MedWatch, and http://www.fda.gov/Drugs. |
Pamidronate is used to treat high levels of calcium in the blood that may be caused by certain types of cancer. Pamidronate is also used along with cancer chemotherapy to treat bone damage caused by multiple myeloma (cancer that begins in the plasma cells [a type of white blood cell that produces substances needed to fight infection]) or by breast cancer that has spread to the bones. Pamidronate is also used to treat Paget's disease (a condition in which the bones are soft and weak and may be deformed, painful, or easily broken). Pamidronate injection 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.
Pamidronate injection comes as a solution (liquid) to inject into a vein slowly, over 2-24 hours. It is usually injected by a health care provider in a doctor's office, hospital, or clinic. It may be given once every 3-4 weeks, once a day for 3 days in a row, or as a single dose that may be repeated after 1 week or longer. The treatment schedule depends on your condition.
Your doctor may 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.
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 pamidronate injection,
Unless your doctor tells you otherwise, continue your normal diet
Call your doctor if you miss a dose of pamidronate or an appointment to receive a dose of pamidronate.
Pamidronate injection 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 these symptoms, call your doctor immediately:
Pamidronate injection 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/Safety/MedWatch] or by phone [1-800-332-1088].
If you are administering this medication at home, your health care provider will tell you how to store it. Follow these instructions carefully.
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 pamidronate injection.
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: 18 November 2009 |