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Drug Notebook

Generic Name: risedronate

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Actonel
A bisphosphonate - It helps make healthy bone and to slow bone loss in patients with Paget's disease... more
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FDA Alerts

Special Alerts:

[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.

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risedronate
(ris ED roe nate)
What is this medicine?What side effects may I notice from receiving this medicine?How should I use this medicine?What if I miss a dose?What may interact with this medicine?What should I watch for while using this medicine?What should I tell my health care provider before I take this medicine?Can I stop taking the medication if I feel better?I am on so many medications; do I have to take them all?

What is this medicine?

RISEDRONATE reduces calcium loss from bones. It helps make healthy bone and to slow bone loss in patients with Paget's disease and osteoporosis. It may be used in others at risk for bone loss. This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor as soon as possible:

  • allergic reactions such as skin rash or itching, hives, swelling of the face, lips, throat, or tongue
  • black or tarry stools
  • changes in vision
  • heartburn or stomach pain
  • jaw pain, especially after dental work
  • pain or difficulty when swallowing
  • redness, blistering, peeling, or loosening of the skin, including inside the mouth
Side effects that usually do not require medical attention (report to your doctor if they continue or are bothersome):
  • bone, muscle, or joint pain
  • changes in taste
  • diarrhea or constipation
  • eye pain or itching
  • headache
  • nausea or vomiting
  • stomach gas or fullness
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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How should I use this medicine?

You must take this medication exactly as directed or you will lower the amount of medicine you absorb into your body or you may cause your self harm. Take this medicine by mouth first thing in the morning, after you are up for the day. Do not eat or drink anything before you take this medicine. Swallow the tablets with a full glass (6 to 8 fluid ounces) of plain water. Do not take the tablets with any other drink. Do not chew or crush the tablet. After taking this medicine, do not eat breakfast, drink, or take any other medicines or vitamins for at least 30 minutes. Stand or sit up for at least 30 minutes after you take this medicine; do not lie down. Do not take your medicine more often than directed. A patient information sheet for the product will be given with each prescription and refill. Read this sheet carefully each time. This sheet may change. Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

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What if I miss a dose?

If you miss a dose, do not take it later in the day. Take your normal dose the next morning. Do not take double or extra doses.

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What may interact with this medicine?

  • antacids like aluminum hydroxide or magnesium hydroxide
  • aspirin
  • calcium supplements
  • iron supplements
  • NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
  • thyroid hormones
  • vitamins with minerals
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

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What should I watch for while using this medicine?

Visit your doctor or health care professional for regular check ups. It may be some time before you see the benefit from this medicine. Your doctor or health care professional may order blood tests and other tests to see how you are doing. You should make sure you get enough calcium and vitamin D while you are taking this medicine, unless your doctor tells you not to. Discuss the foods you eat and the vitamins you take with your health care professional. Some people who take this medicine have severe bone, joint, and/or muscle pain. Tell your doctor if you have pain that does not go away or that gets worse.

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What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • dental disease
  • esophagus, stomach, or intestine problems, like acid reflux or GERD
  • kidney disease
  • low blood calcium
  • problems sitting or standing
  • trouble swallowing
  • an unusual or allergic reaction to risedronate, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

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Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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