- Actonel®with Calcium (as a combination product containing Calcium, Risedronate)
[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
Risedronate tablets and delayed-release (long-acting tablets) are 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). Risedronate tablets are also used to treat osteoporosis in men, and in men and women who are taking glucocorticoids (a type of corticosteroid medication that may cause osteoporosis). Risedronate tablets are also 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). Risedronate is in a class of medications called bisphosphonates. It works by preventing bone breakdown and increasing bone density (thickness).
Risedronate comes as a tablet and a delayed-release tablet to take by mouth. The delayed-release tablets are usually taken once a week in the morning, immediately after breakfast. The tablets are usually taken on an empty stomach once a day in the morning, once a week in the morning, once monthly in the morning, or once monthly for two mornings in a row depending on your condition and the dosage prescribed by your doctor. If you are taking risedronate once a week, once monthly, or once monthly for 2 days in a row, take it on the same day every week or month or the same 2 days in a row every month. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take risedronate 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.
Risedronate may not work properly and may damage the esophagus (tube that connects 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 risedronate tablets immediately after you get out of bed in the morning and before you eat or drink anything. You must take risedronate delayed-release tablets immediately after breakfast. Never take risedronate 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 while you are sitting or standing. Swallow the delayed-release tablets with at least 4 ounces (120 mL) of plain water while you are sitting or standing. Never take risedronate with tea, coffee, juice, mineral water, milk, other dairy drinks, or any liquid other than plain water.
- Swallow the tablets and delayed-release tablets whole. Do not split, chew, or crush them. Do not suck on the tablets or hold them in your mouth for any length of time.
- After you take risedronate, do not eat, drink, or take any other medications for at least 30 minutes. Do not lie down for at least 30 minutes after you take risedronate. Sit upright or stand upright until at least 30 minutes have passed.
Risedronate controls osteoporosis and Paget's disease of bone but does not cure these conditions. Risedronate helps to treat and prevent osteoporosis only as long as it is taken regularly. Continue to take risedronate even if you feel well. Do not stop taking risedronate without talking to your doctor, but talk to your doctor from time to time about whether you still need to take risedronate.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with risedronate 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 risedronate,
- tell your doctor and pharmacist if you are allergic to risedronate, any other medications, or any of the ingredients in risedronate tablets or delayed-release tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients
- 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; or oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone). If you are taking the delayed-release tablets, you should also tell your doctor if you are taking an H2 blocker such as cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid), and ranitidine (Zantac) or a proton pump inhibitor such as esomeprazole (Nexium), lansoprazole (Prilosec), omeprazole (Prevacid, Zegarid), pantoprazole (Protonix), and rabeprazole (AcipHex). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- you should know that Actonel and Atelvia both contain risedronate. You cannot take both of these medications at the same time.
- if you are taking any other oral medications including vitamins, supplements, or antacids, take them at least 30 minutes after you take risedronate.
- tell your doctor if you have or have ever had a low level of calcium in your blood or any problems with your esophagus and if you are unable to sit upright or stand upright for at least 30 minutes. Your doctor may tell you that you should not take risedronate.
- tell your doctor if you are undergoing radiation therapy; if you have or have ever had difficulty swallowing; heartburn; ulcers or other problems with your 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 or are breast-feeding. Also tell your doctor if you plan to become pregnant at any time in the future, because risedronate 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 risedronate.
- you should know that risedronate 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 risedronate. Be sure to brush your teeth and clean your mouth properly while you are taking risedronate. Talk to your doctor before having any dental treatments while you are taking this medication.
- you should know that risedronate may cause severe bone, muscle, or joint pain. You may begin to feel this pain within days, months, or years after you first take risedronate. Although this type of pain may begin after you have taken risedronate for some time, it is important for you and your doctor to realize that it may be caused by risedronate. Call your doctor right away if you experience severe pain at any time during your treatment with risedronate. Your doctor may tell you to stop taking risedronate 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 plenty of foods that are rich in calcium and vitamin D while you are taking risedronate. 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 can prescribe or recommend a supplement.
If you miss a dose of once-daily risedronate, do not take it later in the day. Skip the missed dose and take one dose the next morning as usual.
If you miss a dose of once-weekly risedronate, do not take it later in the day. Take one dose the morning after you remember. Then return to taking one dose once each week on your regularly scheduled day.
If you miss a dose of once-monthly risedronate but remember more than 7 days before your next scheduled dose, take the missed dose the morning after you remember. If you remember less than 7 days before your next scheduled dose, do not take the missed dose. Instead, wait until the morning of your next scheduled dose and then take risedronate as usual.
If you miss one or both doses of the two days in a row, once-monthly risedronate but remember more than 7 days before your next scheduled dose, you can take the missed doses. Take the first missed dose the morning after you remember and if you missed both doses, take the second missed dose the morning after you take the first one. If you remember less than 7 days before your next scheduled dose, do not take the missed dose(s). Instead, wait until the morning of your next scheduled dose and then take risedronate as usual.
If you miss doses of risedronate and do not know what to do, call your doctor. Always take risedronate first thing in the morning. Never take a double dose to make up for a missed one, and never take more than one dose in one day.
Risedronate may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- dry mouth
- stomach pain
- leg cramps
- back pain
- frequent or urgent need to urinate
- painful urination
Some side effects can be serious. If you experience any of the following side effects, call your doctor immediately before you take any more risedronate:
- difficulty swallowing or pain when swallowing
- new or worsening heartburn
- chest pain
- blisters on skin
- swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
- difficulty breathing
- muscle spasms, twitching, or cramps
- numbness or tingling around mouth or in hands or feet
- swollen, red, or painful eyes
- sensitivity to light
- 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
Risedronate may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
Taking a bisphosphonate medication such as risedronate 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 risedronate. Talk to your doctor about the risks of taking risedronate.
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.
Symptoms of overdose may include the following:
- numbness or tingling around mouth or in hands or feet
- muscle spasms, cramps, or twitches
Keep all appointments with your doctor and the laboratory.
Before having any laboratory test or bone imaging study, tell your doctor and the laboratory personnel that you are taking risedronate.
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: August 15, 2011.