Alendron Safety Questions, Alendron Answers
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Alendron Safety Reports
Total Alendron reports: 1.Alendron FDA safety alerts: 2007 .
Reported deaths: 3 Reported hospitalizations: 8.
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Reported Alendron Side Effects: dehydration.
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Alendron Side Effects Report #5346220-3
Physician from GERMANY reported ALENDRON problem on May 24, 2007. Male patient, weighting 94.14 lb, was diagnosed with osteoporosis, sleep disorder, angioplasty, stent placement and was treated with ALENDRON. After drug was administered, patient experienced the following problems/side effects: dehydration. ALENDRON dosage: unknown. During the same period patient was treated with CALCIMAGON, FLUNITRAZEPAM, ISCOVER. Patient was hospitalized. Patient recovered.
Drug Information: Alendronate
URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a601011.html
(a len' 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.
Alendronate is used to treat and prevent 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). Alendronate is also used to treat osteoporosis in men and women, who are taking corticosteroids (a type of medication that may cause osteoporosis in some patients). Alendronate is 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). Alendronate is in a class of medications called bisphosphonates. It works by preventing bone breakdown and increasing bone density (thickness).
How should this medicine be used?
Alendronate comes as a tablet and a solution (liquid) to take by mouth. The solution is usually taken on an empty stomach once a week in the morning. The 5-mg and 10-mg tablets are usually taken on an empty stomach once a day in the morning, and the 30-mg and 70-mg tablets are usually taken on an empty stomach once a week in the morning. The 40-mg tablets are usually taken once a day in the morning for six months to treat Paget's disease of bone. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take alendronate exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Alendronate 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 alendronate just after you get out of bed in the morning, before you eat or drink anything. Never take alendronate at bedtime or before you wake up and get out of bed for the day.
- Swallow alendronate tablets with a full glass (6 to 8 ounces, about 1 cup) of plain water. Drink at least a quarter of a cup (2 ounces) of plain water after you drink alendronate liquid. Never take alendronate 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 alendronate, do not eat, drink, or take any other medications (including vitamins or antacids) for at least 30 minutes. Do not lie down for at least 30 minutes after you take alendronate. Sit upright or stand upright until at least 30 minutes have passed and you have eaten your first food of the day.
Alendronate controls osteoporosis and Paget's disease of bone but does not cure these conditions. It may take 3 months or longer before your bone density begins to increase. Alendronate helps to treat and prevent osteoporosis only as long as it is taken regularly. Continue to take alendronate even if you feel well. Do not stop taking alendronate without talking to your doctor.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
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.
Before taking alendronate,
- tell your doctor and pharmacist if you are allergic to alendronate, any other medications, or any of the ingredients in alendronate tablets or liquid. Ask your pharmacist 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 medications (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Naprosyn, Aleve); cancer chemotherapy; or 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 other medications including supplements, vitamins, or antacids by mouth, take them at least 30 minutes after you take alendronate.
- tell your doctor if you are unable to sit upright or stand upright for at least 30 minutes and if you have or have ever had a low level of calcium in your blood or any problems with your esophagus. Your doctor may tell you that you should not take alendronate.
- 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 stomach problems;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 alendronate may remain in your body for many years after you stop taking it. Call your doctor if you become pregnant during or after your treatment.
- you should know that alendronate 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 alendronate. Be sure to brush your teeth and clean your mouth properly while you are taking alendronate. Talk to your doctor before having any dental treatments while you are taking this medication.
- you should know that alendronate may cause serious damage to the lining of your mouth, esophagus, or stomach, especially if you do not take it according to the directions listed in the HOW section above. If you experience any of the following symptoms, stop taking alendronate, and call your doctor immediately: new or worsening heartburn, difficulty swallowing, pain on swallowing, or chest pain.
- 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.
What special dietary instructions should I follow?
You should eat and drink plenty of foods and drinks that are rich in calcium and vitamin D while you are taking alendronate. 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 can prescribe or recommend a supplement.
What should I do if I forget a dose?
If you miss a dose of once-daily alendronate, 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 alendronate, take one dose the morning after you remember. Then return to taking one dose once each week on your regularly scheduled day. Never take a double dose to make up for a missed one, and never take more than one dose in 1 day.
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.
Alendronate may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- nausea
- stomach pain
- constipation
- diarrhea
- gas
- bloating or fullness in the stomach
- change in ability to taste food
- bone, muscle, or joint pain
- headache
- dizziness
- flu-like symptoms
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately before you take any more alendronate:
- new or worsening heartburn
- difficulty swallowing
- pain on swallowing
- chest pain
- bloody vomit or vomit that looks like coffee grounds
- black, tarry, or bloody stools
- fever
- blisters or peeling skin
- rash (may be made worse by sunlight)
- itching
- hives
- swelling of eyes, face, lips, tongue, or throat
- difficulty breathing
- hoarseness
- painful or swollen gums
- loosening of the teeth
- numbness or heavy feeling in the jaw
- poor healing of the jaw
- eye pain
Alendronate 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). Do not freeze alendronate solution. 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, 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:
- heartburn
- nausea
- stomach pain
- bloody vomit or vomit that looks like coffee grounds
- difficulty swallowing or pain when swallowing
- bloody or black and tarry stool
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 alendronate.
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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