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FOSAMAX®

(alendronate)

What is alendronate or Fosamax®?

Alendronate, or Fosamax® is a compound that alters the cycle of bone formation and breakdown in your body. Fosamax® can increase new bone formation in the body. Alendronate, or Fosamax® can be used to treat and prevent osteoporosis. Fosamax® can also be used to treat Paget's disease. Alendronate, or Fosamax® is also used to treat osteoporosis that is caused by treatment with a corticosteroid. Fosamax® may also be used for purposes other than those listed in this medication guide.

Talk to your doctor to decide if the prescription medication Fosamax® is right for you.

What are the possible side effects of Fosamax®?

Common Side effects of Fosamax® can include: bone and joint pain, indigestion, diarrhea, muscle pain, abdominal pain, nausea, and constipation

Less common side effects of Fosamax® can include: Abdominal distention, difficulty swallowing, acid backup, excessive gas, esophageal ulcers, headache, vomiting, and stomach ulcers

Very rare side effects of Fosamax® can include: Changes in taste, esophageal blockage or perforation, rash, mouth sores, muscle cramps, hives, redness of the skin, swollen face and throat, and inflammation of the stomach, and eye pain

Side effects are difficult to predict. Some side effects are normal, while other side effects are not. Always discuss any side effects you are experiencing while taking any prescription medication, including Fosamax®, with your doctor.

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Who should avoid Fosamax®?

Patients with certain disorders of the esophagus, who have inability to stand or sit upright for at least 30 minutes, patients with low levels of calcium in their blood, severe kidney disease, or patients who are allergic to Fosamax®, should all avoid taking Fosamax®.

You should always talk to your doctor before stopping or starting any prescription medication, including Fosamax®.

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Actonel® - A possible alternative to Fosamax®

Actonel® is a possible alternative to Merck®'s Fosamax®. The alternative, Actonel® is a prescription drug that can be used to treat postmenopausal osteoporosis, glucocorticoid-induced osteoporosis in men and women, and Paget's disease.

The most common side effects of Actonel ® include: flu syndrome, chest pain, diarrhea, abdominal, pain,   nausea, constipation, swelling, joint pain, headache, dizziness, and rash. These are just some of the side effects you may experience while taking Actonel®. Discuss these side effects along with any other side effects you may experience while taking Actonel®.

Side effects are difficult to predict. Some side effects are normal, while other side effects are not. Some side effects are not listed here, so as always, discuss any side effects you are experiencing while taking any prescription medicine, including Actonel®.

Always consult with your doctor before taking any prescription medication, including Fosamax® and Actonel®.

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What is ONJ or Osteonecrosis of the jaw?

Osteonecrosis of the jaw (ONJ) is a condition in which the bone tissue of the jaw fails to heal properly after a minor trauma. This can lead to the bone being exposed, which can eventually lead to an infection and/or fracture. Osteonecrosis of the jaw (ONJ) can sometimes require surgery later to fix this problem. Treatment and prevention is essential in protecting the jawbone from Osteonecrosis of the jaw (ONJ). Individuals using Fosamax® or similar bisphosphonates might want to consider avoiding tooth extractions and other dental work while on these prescription drugs. This is because a minor trauma like a tooth extraction could cause Osteonecrosis of the jaw (ONJ).

According to Merck, the maker of Fosamax, the risk of a healthy person developing ONJ is very remote. Merck estimate's it to be less than 1 out of 100,000 patients a year.

Fosamax® in the News


Fosamax® and Other Osteoporosis Drugs Allegedly Linked to “Dead Jaw” Disease - Osteonecrosis of the jaw or ONJ

Dead Jaw is also known as ONJ, or Osteonecrosis of the jaw. Osteonecrosis of the jaw is an uncommon condition that involves the loss or breakdown of the jawbone. Symptoms include pain, swelling, or infection of the gums, loosening of the teeth, poor healing of the gums, and numbness or feeling of heaviness in the jaw.

If you experience any of the symptoms of Osteonecrosis of the jaw, or ONJ, contact your oncologist and dentist immediately.

Fosamax® and Fosamax® Plus D together are the most prescribed medicine for osteoporosis in post-menopausal women.

For more information about the prescription medication Fosamax®, visit http://www.fosamax-information.com

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Leading Osteoporosis Researcher to Explore Potential Use of Protein Therapy to Treat Osteoporosis

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Fosamax® Warning

In September 2004 the FDA issued a Fosamax® warning report. This report also included 3 other drugs in the same class: Zometa®, Aredia®, and Actonel®. The FDA concluded that the label of Fosamax® should include a warning about osteonecrosis. Merck® revised the label on 2005. Some critics have said that the label is not a sufficient enough warning. Despite all of this, Fosamax® is still Merck®'s 2nd best selling drugs. It brought in $3.2 billion in sales in 2005.

Merck® is currently facing many lawsuits regarding the drug Fosamax®, because there was no warning label prior to 2005. The lawsuits will argue that Merck® knew about the dangers of Fosamax®, but did nothing to warn potential patients.

Statement by Merck & Co., Inc. Regarding FOSAMAX® (alendronate sodium) and Rare Cases of Osteonecrosis of the Jaw

Merck is committed to putting patients first and providing accurate information regarding the efficacy, safety and tolerability of our medicines.  Merck offers the following statement in response to news reports concerning the osteoporosis medication FOSAMAX ® (alendronate sodium) and reports of jaw problems associated with delayed healing and infection of the jaw often following tooth extraction. The condition is known as osteonecrosis of the jaw (ONJ).

ONJ is not well understood and may occur for a number of reasons. Most reported cases of bisphosphonate-associated osteonecrosis have been in cancer patients treated with intravenous bisphosphonates, but cases have occurred in patients with postmenopausal osteoporosis and other diagnoses.  Known risk factors for osteonecrosis include a diagnosis of cancer, concomitant therapies (e.g., chemotherapy, radiotherapy, corticosteroids), poor oral hygiene, and co-morbid disorders (e.g., pre-existing dental disease, anemia, coagulopathy, infection).

In controlled clinical trials involving more than 17,000 patients, contributing as much as 10 years' data with alendronate, there have been no reports of ONJ.  This includes ~3000 osteoporosis patients taking alendronate for 3-5 years and ~800 patients taking alendronate for 8-10 years. Since their market introduction, over 191 million total prescriptions have been dispensed for FOSAMAX/FOSAMAX Plus D, Actonel (risedronate) and Boniva (ibandronate) in the U.S. and 77% of these have been dispensed as FOSAMAX/FOSAMAX Plus D.

In worldwide post-marketing experience with FOSAMAX/FOSAMAX Plus D, rare reports consistent with osteonecrosis of the jaw have been received. Many of these reports lack sufficient clinical details to make definitive assessments and/or are confounded, particularly since a generally accepted definition of ONJ in the general population is unknown. As of March 31, 2006 , Merck estimates the worldwide, cumulative reporting rate of osteonecrosis of the jaw to be <1/100,000 patient-treatment-years, regardless of causality.

On January 31, 2005 , Merck received a request dated January 24, 2005 from the Food and Drug Administration to update the label for FOSAMAX to include bisphosphonate class labeling for ONJ.  Merck submitted a draft revised label to FDA on March 1, 2005 .  FDA comments on this draft revised label were received in June 2005, and the new label was made publicly available in July, 2005.

Rare cases of ONJ have also been reported in patients who do not have osteoporosis and who have not taken any bisphosphonate medicines. These cases have been discussed in articles that have been published in the medical literature.

All products containing FOSAMAX include the following language pertaining to ONJ in the "Precautions" section of their respective package circular:

Information for ONJ is also provided in the "Adverse Reactions" section of the package circular as well as in the patient package insert for the products containing FOSAMAX.   As part of a review of your medical history with your healthcare providers (such as dentists, physicians, oral surgeons or others), be sure to include any product containing FOSAMAX in your list of medicines and talk to your healthcare provider if you have any questions about FOSAMAX.  

FOSAMAX is indicated for the treatment of osteoporosis in postmenopausal women.  For the treatment of osteoporosis, FOSAMAX increases bone mass and reduces the incidence of fracture, including those of the hip and spine.  FOSAMAX is also indicated to increase bone mass in men with osteoporosis. 

Osteoporosis, the most prevalent bone disease in the U.S. , can lead to bone loss and an increased risk of fractures.  Over 10 million Americans over the age of 50 have osteoporosis and another 34 million have low bone mass. Osteoporosis is especially common in women after menopause, but also occurs in older men.  Most often, it is due to an increase in the rate of resorption (breakdown) of bone tissue that is not matched by the rate of bone formation.  The risk of having an osteoporosis-related fracture increases with age.  According to the Surgeon General, osteoporosis is a national health threat and by 2020 one in two Americans over the age of 50 will be at risk for fractures from osteoporosis or low bone mass.  In fact, one out of every two women over age 50 will have an osteoporosis-related fracture in their remaining lifetime, with the risk of fracture increasing with age.

Important information about FOSAMAX
FOSAMAX, like other bisphosphonate containing products, should be used with caution in people with certain stomach or digestive problems.  FOSAMAX should not be used if the patient has certain disorders of the esophagus that delay emptying or if the patient is unable to stand or sit upright for at least 30 minutes.  In addition, FOSAMAX should not be used in patients with severe kidney disease or low levels of calcium in their blood, in patients who are allergic to FOSAMAX or in patients who are pregnant or nursing.  Patients who have difficulty swallowing liquids should not take FOSAMAX oral solution.

Some patients may develop severe digestive reactions including irritation, inflammation or ulceration of the esophagus.  The risk of severe esophageal experiences appears to be greater in patients who fail to follow dosing instructions (see prescribing information for more details). Patients who experience new or worsening heartburn, difficulty or pain when swallowing or chest pain should stop taking the drug and call their doctor right away.  Patients who develop severe bone, joint and/or muscle pain at any time should contact their doctor.  

The standard dosing regimen for FOSAMAX includes swallowing the tablet with six to eight ounces of plain water the first thing upon arising for the day and at least 30 minutes before the first food, beverage or medication of the day.  After swallowing FOSAMAX, patients should not lie down for at least 30 minutes and not until after consuming their first food of the day.  Patients should not chew or suck on a tablet of FOSAMAX.

For more information on products containing FOSAMAX, please see and read the prescribing information and patient package insert which are available at www.fosamax.com .

Addendum:  Several independent organizations have published statements related to osteonecrosis of the jaw (ONJ).  Merck & Co, Inc., does not necessarily endorse the perspectives or opinions expressed within these statements.  Also, the prescribing information of currently available intravenous and oral bisphosphonates may provide information about ONJ. To help healthcare professionals in their efforts to understand ONJ, a non-exhaustive list of online addresses associated with independent organizations and available intravenous and oral bisphosphonates is provided as follows.

Information from the National Institutes of Health
http://www.niams.nih.gov/bone/hi/oralhealth_bone.htm

Background from the American Dental Association
http://www.ada.org/prof/resources/topics/osteonecrosis.asp

Statement from the National Osteoporosis Foundation
http://www.nof.org/news/pressreleases/osteonecrosis.htm

Prescribing Information for Oral Bisphosphonates
http://www.fosamax.com/fosamax/shared/documents/english/pi.pdf
http://www.fosamax.com/fosamax/shared/documents/english/pi_plus_d.pdf
http://www.actonel.com/global/prescribingInfo-040506.pdf
http://www.actonel.com/global/prescribingInfo-AwC-040506.pdf
http://www.rocheusa.com/products/Boniva/PI.pdf
http://www.pgpharma.com/pi/US-Didronel.pdf
http://www.products.sanofi-aventis.us/skelid/skelid.html

Prescribing Information for IV Bisphosphonates
http://www.rocheusa.com/products/Boniva/Injection_PI.pdf
http://www.pharma.us.novartis.com/product/pi/pdf/Zometa.pdf
http://www.pharma.us.novartis.com/product/pi/pdf/aredia.pdf

Source: http://www.merck.com/newsroom/press_releases/product/fosamax_statement.html

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