Fosamax , also known as alendronate sodium
, is an osteoporosis drug designed to build up brittle bones in men and postmenopausal women at risk for osteoporosis
. Fosamax is manufactured by Merck & Co
., and was first approved
by the FDA for use in the United States in 1995. Fosamax belongs to a class of bone density drugs called bisphosphonates that help the body to reabsorb calcium. Bisphosphonates help reduce bone fractures in the hip and the spine (vertical compression fractures) by gradually increasing bone mass.
Fosamax Advisory Information
It is important to take Fosamax on an empty stomach. After taking the dose for the day on an empty stomach, the patient must remain in an upright position for at least thirty minutes. According to the manufacturer, Fosamax has a tendency to irritate the esophagus, therefore patients must take precautions to avoid any reflux for about thirty minutes after taking the morning dose. Fosamax is a nonhormonal medication that retards bone loss and increases bone density, placing patients at a reduced risk for fractures and long-term osteoporosis.
Many patients on long-term Fosamax therapy for osteoporosis have reported serious musculoskeletal pain, and a small percentage has come down with a debilitating condition known as osteonecrosis of the jaw
(ONJ). ONJ is a condition in which jaw tissue fails to heal fully after a tooth extraction or some other maxillofacial surgery or dental procedure. The jawbone tissue begins to feel heavy and numb, and if not treated the jawbone tissue dies. Designed to retard bone loss, Fosamax paradoxically causes reduced cellular activity in healing bone tissue, which may account for loss of blood supply to the jaw and resulting ONJ.
2010Merck Loses Fosamax Trial
On June 25, a jury in New York awarded $8 million to a Shirley Boles, of Florida, who claimed Fosamax, destroyed her jaw bone
. She took Fosamax for ten years.
The verdict is the first loss for the drugmaker. Jurors found that Fosamax is defectively designed and unreasonably dangerous and that the drug was negligently designed.
The first trial over Fosamax
ended in a mistrial in September 2009 after the jury deadlocked and unable to reach a unanimous verdict.
Merck intends to challenge the verdict. The drugmaker faces at least 1,400 more lawsuits alleging Fosamax harmed patients.FDA Evaluating Fosamax Safety
The U.S. Food and Drug Administration (FDA) is evaluating the safety issues involving bisphosphonate
medications and atypical subtrochanteric femur fractures (fractures in the bone just below the hip joint), following recent study findings.
New research presented at the American Academy of Orthopaedic Surgeons
annual meeting suggests staying on Fosamax and similar drugs for five or more years can increase the risk of hip fractures
. Two new studies found the bones of post-menopausal women who take bisphosphonates (Actonel, Boniva, Fosamax, Reclast) to treat osteoporosis can stop rejuvenating and become brittle after long-term use. Researchers urge limiting the length of time people take the drugs.
The first trial over Fosamax
ended in a mistrial in September 2009 after the jury told the court it was deadlocked and unable to reach a unanimous verdict.
The case was the first among about 900 federal and state cases pending against Merck
A letter published in the January 2009 issue of the New England Journal of Medicine
(NEJM), indicated 23 cases of esophageal cancer in patients taking Fosamax
, including eight deaths, have been reported to the agency since the drug was first marketed in 1995.
In July 2008 the FDA reported szeveral adverse events relating to long-term bisphosphonate therapy and bone shear, specifically, sudden shattering and breakage of the femur. Several patients on long-term Fosamax therapy for oseteoporosis reported incidence of shattered bones after no stress or minimal stress to the bone.
In April 2008, researchers at the University of Washington, found Fosamax
may be linked to a doubling of a woman’s risk of developing atrial fibrillation.
Atrial fibrillation (AF) is a chronic irregular heart beat that can cause dizziness and fainting as well as fatigue. In rare cases it can lead to a blood clots and stroke.2007
After receiving numerous warnings from cardiologists, the FDA alerted the public in 2007 to an ongoing safety review of all bisphosphonate drugs, including Fosamax. The review warned of the potentiality of a chronic irregular heartbeat in patients who have been on bisphosphonate therapy for several years. Patients on Fosamax who have been diagnosed with atrial fibrillation should consult their physician immediately.
Please consult with your physician about any questions you may have concerning Fosamax and other bisphosphonates. If you are experiencing any of the side effects or symptoms associated with Fosamax, it may be important for you to discuss treatment alternatives to your current medication.
If you have legal questions or believe that you have been injured as a result of Fosamax, you should contact an attorney who has experience in this area of practice.IMPORTANT - You should never stop taking any medication without first consulting with your prescribing physician.
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