[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.
Tiludronate 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). Tiludronate is in a class of medications called bisphosphonates. It works by preventing bone breakdown and increasing bone density (thickness).
Tiludronate comes as a tablet to take by mouth. It is usually taken on an empty stomach once a day for 3 months. This treatment may be repeated if symptoms come back or worsen after some time has passed. Take tiludronate at around the same time 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 tiludronate exactly as directed. Do not take it more or less often or for a longer period of time than prescribed by your doctor.
Take tiludronate with a full glass (6 to 8 ounces [180 to 240 milliliters]) of plain water. Do not take tiludronate with any other liquid, including mineral water. Do not eat or drink for 2 hours before or 2 hours after you take tiludronate. Do not lie down for at least 30 minutes after taking this medication.
Tiludronate controls Paget's disease of bone only when it is taken as prescribed. Do not stop taking tiludronate without talking to your doctor.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
Before taking tiludronate,
- tell your doctor and pharmacist if you are allergic to tiludronate, any other medications, or any of the ingredients in tiludronate tablets. Ask your pharmacist for a list of the ingredients.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: chemotherapy medications for cancer 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 aspirin, indomethacin (Indocin), or calcium or mineral supplements, take them 2 hours before or 2 hours after you take tiludronate. If you are taking antacids containing calcium, magnesium, or aluminum (Maalox, Mylanta, Tums, others), take them at least 2 hours after you take tiludronate.
- tell your doctor if you are unable to stand or sit upright for at least 30 minutes after taking tiludronate. Your doctor will probably tell you not to take tiludronate.
- tell your doctor if you are undergoing radiation therapy and if you have or have ever had difficulty or pain when swallowing; heartburn, ulcers, or other problems with your stomach or esophagus (tube connecting the mouth to the stomach); anemia (condition in which the red blood cells do not bring enough oxygen to all the parts of the body); cancer; any type of infection, especially in your mouth; problems with your mouth, teeth, or gums; any condition that stops your blood from clotting normally; or dental or kidney disease.
- 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 tiludronate may remain in your body for years after you stop taking it. Call your doctor if you become pregnant during or after your treatment.
- you should know that tiludronate 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 tiludronate. Be sure to brush your teeth and clean your mouth properly while you are taking tiludronate. Talk to your doctor before having any dental treatments while you are taking this medication.
- you should know that tiludronate may cause severe bone, muscle, or joint pain. You may begin to feel this pain within days, months, or years after you first take tiludronate. Although this type of pain may begin after you have taken tiludronate for some time, it is important for you and your doctor to realize that it may be caused by tiludronate. Call your doctor right away if you experience severe pain at any time during your treatment with tiludronate. Your doctor may tell you to stop taking tiludronate and your pain may go away after you stop taking the medication.
You should eat and drink plenty of foods and drinks that are rich in calcium and vitamin D while you are taking tiludronate Your doctor will tell you which foods and drinks 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.
Take the missed dose as soon as you remember it. 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.
Tiludronate may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- swelling of the arms, hands, feet, ankles, or lower legs
- pain, burning, numbness, or tingling in the hands or feet
- red or irritated eyes
- changes in vision
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:
- new or worsening heartburn
- difficulty swallowing
- pain on swallowing
- chest pain
Tiludronate may cause other side effects. Call your doctor if you have any unusual problems while you are taking tiludronate.
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].
Keep this medication in the container it came in, tightly closed, and out of reach of children. Do not remove the tablets from the foil strip until you are ready to take them. Store this medication at room temperature and away from excess heat and moisture (not in the bathroom). Talk to your pharmacist about the proper disposal of your medication.
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.
Keep all appointments with your doctor and the laboratory. Your doctor may order certain laboratory tests to check your response to tiludronate.
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.
AHFS® Consumer Medication Information. © Copyright, 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.
Selected Revisions: September 15, 2011.