(e ti droe' nate)
[Posted 07/21/2011]ISSUE:FDA notified healthcare professionals and patients about its ongoing review of data from published studies to evaluate whether use of oral bisphosphonate drugs is associated with an increased risk of cancer of the esophagus. FDA has not concluded that taking an oral bisphosphonate drug increases the risk of esophageal cancer. There are insufficient data to recommend endoscopic screening of asymptomatic patients. FDA will continue to evaluate all available data supporting the safety and effectiveness of bisphosphonate drugs and will update the public when more information becomes available.
BACKGROUND:Oral bisphosphonates are commonly used for the prevention and treatment of osteoporosis as well as to treat other bone diseases such as Paget's disease. There have been conflicting findings from studies evaluating the risk of esophageal cancer. Esophagitis and other esophageal events have been reported, particularly in patients who do not follow the specific directions for use of oral bisphosphonates. See the Data Summary in the Drug Safety Communication for additional details at: Web Site.
RECOMMENDATION:Patients should talk with their healthcare professional about the benefits and risks of taking oral bisphosphonates and how long they should expect to take them. Patients should talk with their healthcare professional if they develop swallowing difficulties, chest pain, new or worsening heartburn, or have trouble or pain when swallowing. Patients should be instructed to carefully follow the directions for use of the oral bisphosphonate drug they are prescribed. For more information visit the FDA website at: Web Siteand Web Site.
WHY is this medicine prescribed?
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?
Etidronate comes as a tablet to take by mouth. It is usually taken once or twice a day on an empty stomach for 3 to 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.
Are there OTHER USES for this medicine?
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?
Before taking etidronate,
- tell your doctor and pharmacist if you are allergic to etidronate or any other medications.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention anticoagulants ('blood thinners') such as warfarin (Coumadin); cancer chemotherapy; and oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- if you are taking vitamin and mineral supplements such as iron, or if you are taking antacids containing calcium, magnesium, or aluminum (Maalox, Mylanta, Tums, others), take them 2 hours before or 2 hours after you take etidronate.
- tell your doctor if you have or have ever had osteomalacia (softening of bones due to a lack of minerals). Your doctor may tell you not to take etidronate.
- tell your doctor if you have or have ever had anemia (condition in which the red blood cells do not bring enough oxygen to all the parts of the body); difficulty swallowing, heartburn, ulcers, or other stomach problems; cancer; enterocolitis (swelling in the intestines); any type of infection, especially in your mouth; problems with your mouth, teeth, or gums; any condition that stops your blood from clotting normally; dental or kidney disease. Tell the doctor who prescribed etidronate if you break a bone at any time during your treatment.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. Also tell your doctor if you plan to become pregnant at any time in the future because etidronate may remain in your body for years after you stop taking it. Call your doctor if you become pregnant during or after your treatment with etidronate.
- you should know that etidronate may cause serious problems with your jaw, especially if you have dental surgery or treatment while you are taking the medication. A dentist should examine your teeth and perform any needed treatments before you start to take etidronate. Be sure to brush your teeth and clean your mouth properly while you are taking etidronate. Talk to your doctor before having any dental treatments while you are taking this medication.
- you should know that etidronate may cause severe bone, muscle, or joint pain. You may begin to feel this pain within days, months, or years after you first take etidronate. Although this type of pain may begin after you have taken etidronate for some time, it is important for you and your doctor to realize that it may be caused by etidronate. Call your doctor right away if you experience severe pain at any time during your treatment with etidronate. Your doctor may tell you to stop taking etidronate and your pain may go away after you stop taking the medication.
What SPECIAL DIETARY instructions should I follow?
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 to take a dose?
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 medicine cause?
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:
- new or worsening heartburn
- chest pain
- swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
- difficulty swallowing or breathing
- blisters on the skin
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 Web Site] or by phone [1-800-332-1088].
What should I know about STORAGE and DISPOSAL of this medication?
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.
What should I do in case of OVERDOSE?
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:
- stomach cramps
- pain, burning, numbness, or tingling in the hands or feet
- muscle spasms and cramps
What OTHER INFORMATION should I know?
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.
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.
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