[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 Site
and Web Site
Ibandronate is used to prevent and treat osteoporosis (a condition in which the bones become thin and weak and break easily) in women who have undergone menopause (''change of life,'' end of menstrual periods). Ibandronate is in a class of medications called bisphosphonates. It works by preventing bone breakdown and increasing bone density (thickness).
Ibandronate comes as a tablet to take by mouth. The 2.5-mg tablet is usually taken once a day in the morning on an empty stomach and the 150-mg tablet is usually taken once a month in the morning on an empty stomach. The 150-mg tablet should be taken on the same date each month. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ibandronate exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Ibandronate may not work properly and may damage the esophagus (tube between the mouth and stomach) or cause sores in the mouth if it is not taken according to the following instructions. Tell your doctor if you do not understand, you do not think you will remember, or you are unable to follow these instructions:
- You must take ibandronate just after you get out of bed in the morning, before you eat or drink anything. Never take ibandronate at bedtime or before you wake up and get out of bed for the day.
- Swallow the tablets with a full glass (6 to 8 ounces [180 to 240 mL]) of plain water. Never take ibandronate with tea, coffee, juice, milk, mineral water, sparkling water, or any liquid other than plain water.
- Swallow the tablets whole; do not split, chew, or crush them. Do not suck on the tablets.
- After you take ibandronate, do not eat, drink, or take any other medications (including vitamins or antacids) for at least 60 minutes. Do not lie down for at least 60 minutes after you take ibandronate. Sit upright or stand upright for at least 60 minutes.
Ibandronate controls osteoporosis but does not cure it. Ibandronate helps to treat and prevent osteoporosis only as long as it is taken regularly. Continue to take ibandronate even if you feel well. Do not stop taking ibandronate without talking to your doctor, but talk to your doctor from time to time about whether you still need to take ibandronate.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with ibandronate and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website ( Web Site
) or the manufacturer's website} to obtain the Medication Guide.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Before taking ibandronate,
- tell your doctor and pharmacist if you are allergic to ibandronate 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 any of the following: aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); 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 any oral medications, including supplements, vitamins, or antacids, take them at least 60 minutes after you take ibandronate.
- tell your doctor if you are unable to sit upright or stand upright for at least 60 minutes and if you have or have ever had a low level of calcium in your blood. Your doctor may tell you not to take ibandronate.
- tell your doctor if are undergoing radiation therapy and 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 problems with your stomach or esophagus (tube that connects the throat to the stomach); 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 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 ibandronate 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 ibandronate 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 ibandronate. Be sure to brush your teeth and clean your mouth properly while you are taking ibandronate. Talk to your doctor before having any dental treatments while you are taking this medication.
- you should know that ibandronate may cause severe bone, muscle, or joint pain. You may begin to feel this pain within days, months, or years after you first take ibandronate. Although this type of pain may begin after you have taken ibandronate for some time, it is important for you and your doctor to realize that it may be caused by ibandronate. Call your doctor right away if you experience severe pain at any time during your treatment with ibandronate. Your doctor may tell you to stop taking ibandronate and your pain may go away after you stop taking the medication.
- talk to your doctor about other things you can do to prevent osteoporosis from developing or worsening. Your doctor will probably tell you to avoid smoking and drinking large amounts of alcohol and to follow a regular program of weight-bearing exercise.
You should eat and drink plenty of foods and drinks that are rich in calcium and vitamin D while you are taking ibandronate. 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.
If you forget to take the daily 2.5-mg tablet, do not take it later in the day. Skip the missed dose and continue your regular dosing schedule the next morning. Do not take two tablets of ibandronate on the same day.
If you forget to take the once-monthly 150-mg tablet, and your next scheduled day to take ibandronate is more than 7 days away, take one tablet the morning after you remember. Then return to taking one tablet each month on the regularly scheduled date. If you forget to take the once-monthly 150-mg tablet and your next scheduled day to take ibandronate is 7 or fewer days away, skip the dose and wait for your next scheduled day. You should not take two 150-mg tablets of ibandronate within 1 week.
If you are not sure what to do if you miss a dose of ibandronate, call your doctor.
Ibandronate may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- stomach pain
- fever, sore throat, chills, cough, and other signs of infection
- frequent or urgent need to urinate
- painful urination
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately before you take any more ibandronate:
- new or worsening heartburn
- difficulty swallowing
- pain on swallowing
- upper chest pain
- painful or swollen gums
- loosening of the teeth
- numbness or heavy feeling in the jaw
- poor healing of the jaw
- dull, aching pain in the hips, groin, or thighs
Ibandronate may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
Taking a bisphosphonate medication such as ibandronate for osteoporosis may increase the risk that you will break your thigh bone(s). You may feel pain in your hips, groin, or thighs for several weeks or months before the bone(s) break, and you may find that one or both of your thigh bones have broken even though you have not fallen or experienced other trauma. It is unusual for the thigh bone to break in healthy people, but people who have osteoporosis may break this bone even if they do not take ibandronate. Talk to your doctor about the risks of taking ibandronate.
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. 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 overdose, give the victim a full glass of milk and 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. Do not allow the victim to lie down and do not try to make the victim vomit.
Symptoms of overdose may include the following:
- stomach pain
Keep all appointments with your doctor. Your doctor may order certain tests to check your body's response to ibandronate.
Before having any bone imaging study, tell your doctor and healthcare personnel that you are taking ibandronate.
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: March 20, 2012.