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Etidronate

(e ti droe' nate)

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IMPORTANT WARNING:   Return to top

[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.

Why is this medication prescribed?   Return to top

Etidronate is 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) and to prevent and treat heterotopic ossification (growth of bone tissue in an area of the body other than the skeleton) in people who have had total hip replacement surgery (surgery to replace the hip joint with an artificial joint) or in people who have had an injury to the spinal cord. Etidronate is in a class of medications called bisphosphonates. It works by slowing the breakdown of old bone and the formation of new bone.

How should this medicine be used?   Return to top

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.

Etidronate comes as a tablet to take by mouth. It is usually taken once or twice a day on an empty stomach for 3-6 months. This treatment may be repeated if symptoms come back or worsen after some time has passed. Take etidronate at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take etidronate exactly as directed. Do not take more or less of it or take it more often or for a longer period of time than prescribed by your doctor.

You may swallow etidronate tablets with water or plain fruit juice. Do not swallow the tablets with milk, calcium fortified juice, or other drinks that contain calcium.

Do not eat for 2 hours before and 2 hours after you take etidronate. It is especially important not to eat or drink foods or drinks that are high in calcium such as milk for 2 hours before and after you take etidronate.

If you are taking etidronate to treat Paget's disease of bone, it may take some time for your condition to improve. You may experience new or worsening bone pain, especially at the beginning of your treatment. Tell your doctor about any new or worsening symptoms you experience, but do not stop taking etidronate without talking to your doctor.

Other uses for this medicine   Return to top

Etidronate is also used sometimes to treat and prevent osteoporosis (condition in which the bones become thin and weak and may break easily) caused by corticosteroids (a type of medication that may cause osteoporosis). Talk to your doctor about the possible risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?   Return to top

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 taking etidronate,

What special dietary instructions should I follow?   Return to top

It is important that you get enough calcium and vitamin D and eat a balanced diet while you are taking etidronate. Your doctor will tell you which foods are good sources of these nutrients and how many servings you need each day. If you find it difficult to eat enough of these foods, tell your doctor. In that case, your doctor may prescribe or recommend a supplement.

What should I do if I forget a dose?   Return to top

If you have not already eaten, take the missed dose as soon as you remember it. If you have already eaten, take the missed dose 2 hours after you last ate. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?   Return to top

Etidronate 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:

Etidronate 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].

What storage conditions are needed for this medicine?   Return to top

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose   Return to top

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:

What other information should I know?   Return to top

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 may order certain lab tests to check your body's response to etidronate.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

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.

Brand names   Return to top

  • Didronel®

Other names   Return to top

  • EHDP

Last Revised - 05/01/2008


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