Etidronate Safety Questions, Etidronate Answers
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Etidronate Safety Reports
Total Etidronate reports: 7.Etidronate FDA safety alerts: 2007 .
Reported deaths: 1 Reported hospitalizations: 2.
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Reported Etidronate Side Effects: stomach discomfort, breast cyst, breast cancer female, toxic epidermal necrolysis, staphylococcal sepsis, pneumonia, multi-organ failure, apache ii score increased, retinal detachment, no therapeutic response, hypertension.
More About Etidronate.
Etidronate Side Effects Report #5244848-2
Pharmacist from CANADA reported ETIDRONATE problem on Feb 09, 2007. Female patient, 74 years of age, weighting 110.0 lb, was diagnosed with osteoporosis and was treated with ETIDRONATE. After drug was administered, patient experienced the following problems/side effects: leukaemia. ETIDRONATE dosage: unknown. During the same period patient was treated with ACTONEL, TRAVATAN. Patient recovered.
Etidronate Side Effects Report #5248048-1
ETIDRONATE problem was reported by a Pharmacist from CANADA on Feb 12, 2007. Female patient, 86 years of age, was treated with ETIDRONATE. After drug was administered, patient experienced the following problems/side effects: non-hodgkin's lymphoma. ETIDRONATE dosage: unknown. During the same period patient was treated with DIDRONEL, METOPROLOL TARTRATE. Patient recovered.
Etidronate Side Effects Report #5248051-1
Pharmacist from CANADA reported ETIDRONATE problem on Feb 12, 2007. Female patient, 76 years of age, was treated with ETIDRONATE. After drug was administered, patient experienced the following problems/side effects: non-hodgkin's lymphoma stage iii. ETIDRONATE dosage: unknown. During the same period patient was treated with ACTONEL, COZAAR, DIABETA, GLIBENCLAMIDE). Patient recovered.
Etidronate Side Effects Report #5339449-1
ETIDRONATE problem was reported by a Consumer or non-health professional from CANADA on May 18, 2007. Female patient was treated with ETIDRONATE. After drug was administered, patient experienced the following problems/side effects: dizziness, fall, loss of consciousness, syncope. ETIDRONATE dosage: unknown. During the same period patient was treated with WARFARIN. Patient was hospitalized. Patient recovered.
Etidronate Side Effects Report #5345394-8
Consumer or non-health professional from CANADA reported ETIDRONATE problem on May 18, 2007. Female patient, 79 years of age, was diagnosed with osteoporosis and was treated with ETIDRONATE. After drug was administered, patient experienced the following problems/side effects: hypertension, no therapeutic response, retinal detachment. ETIDRONATE dosage: unknown. During the same period patient was treated with GLUCOSAMINE SULPHATE, VITAMIN D, DOMPERIDONE, RABEPRAZOLE, SENOKOT. Patient recovered.
Etidronate Side Effects Report #5412969-7
ETIDRONATE problem was reported by a Health Professional from NETHERLANDS on July 26, 2007. Female patient, 72 years of age, was treated with ETIDRONATE. After drug was administered, patient experienced the following problems/side effects: apache ii score increased, multi-organ failure, pneumonia, staphylococcal sepsis, toxic epidermal necrolysis. ETIDRONATE dosage: unknown. Patient was hospitalized. Patient died.
Etidronate Side Effects Report #5429284-8
Consumer or non-health professional from CANADA reported ETIDRONATE problem on Aug 16, 2007. Female patient, 70 years of age, was diagnosed with bone disorder and was treated with ETIDRONATE. After drug was administered, patient experienced the following problems/side effects: breast cancer female, breast cyst, stomach discomfort. ETIDRONATE dosage: unknown. During the same period patient was treated with ETIDRONATE DI, DILTIAZEM, DIGOXIN, DOMPERIDONE, ARIMIDEX, ZOCOR. Patient recovered.
Drug Information: Etidronate
URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a682581.html
(e ti droe' nate)IMPORTANT WARNING:
| [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. |
Why is this medication prescribed?
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 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. To help you remember to take etidronate, take it 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
Etidronate is also used sometimes to treat and prevent osteoporosis caused by corticosteroids (a type of medication that may cause osteoporosis) treatment. 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 so 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.
What special dietary instructions should I follow?
It is important 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?
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?
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 may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- nausea
- diarrhea
- bone, joint, and/or muscle pain
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:
- swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
- hoarseness
- difficulty swallowing or breathing
- blisters on the skin
- fever
Etidronate may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
What storage conditions are needed for this medicine?
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
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:
- vomiting
- stomach cramps
- diarrhea
- pain, burning, numbness, or tingling in the hands or feet
- muscle spasms and cramps
What other information should I know?
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.
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