Fosamax (bisphosphonate) Side Effects

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Fosamax (bisphosphonate) side effects have been reported to include femur fractures and osteonecrosis of the jaw. On October 13, 2010, the U.S. Food and Drug Administration (FDA) announced that it would require new warnings to be placed on the labels of certain bisphosphonate medications including Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia, and Reclast. The label changes, to be added to the drugs’ Warnings and Precautions section, will reflect the increased risk of atypical fractures of the thigh associated with bisphosphonates. These fractures, called subtrochanteric and diaphyseal femur fractures, had previously been the subject of FDA investigation in patients taking bisphosphonates for osteoporosis. Now, the FDA has taken even more stringent measures to alert the public to this increased risk of femur fractures through alterations to the drugs’ labels.

Bisphosphonates

Bisphosphonates commonly are prescribed to prevent or treat osteoporosis in postmenopausal women. However, bisphosphonates are also approved for the treatment of other medical ailments, including Paget's disease. Bisphosphonates may be used for the prevention of bone fractures in cancer patients and to treat other bone diseases. Bisphosphonates work to increase bone mass and reduce bone fractures. Bisphosphonates may be sold under the names: Actonel, Aredia, Bonefos, Boniva, Didronel, Fosamax, Reclast, Skelid and Zometa. Bisphosphonates may be administered intravenously or orally, depending on which specific drug is utilized. Fosamax is used for the treatment and prevention of osteoporosis. It is manufactured by Merck and was approved by the FDA in 1995. Fosamax is in the class of drugs known as bisphosphonates. Fosamax is a prescribed tablet form of a bisphosphonate. Intravenous forms of bisphosphonates include Zometa and Aredia. Intravenous bisphosphonates typically are used to manage advanced cancers that have metastasized to the bone, causing bone pain and possibly fractures.

Fosamax linked to Femur Fractures

In March 2010, the FDA announced that it would be investigating a possible link between the drug Fosamax (alendronate), and two particular types of leg fractures- subtrochanteric and diaphyseal femur fractures. The announcement came after recent news reports, including an ABC News report investigation, noted that certain osteoporosis drugs, bisphosphonates, may place patients at an increased risk of developing femur fractures. Popular bisphosphonate medications include Fosamax, Actonel, Boniva, and Reclast.

The FDA announced that it would continue to work closely with outside experts to gather information concerning the link between the osteoporosis drugs and a risk of atypical subtrochanteric and diaphyseal femur fractures. Atypical subtrochanteric fractures are fractures in the bone just below the hip joint. Diaphyseal femur fractures are fractures occurring in the long part of the thigh bone and are very uncommon. These fractures are estimated to account for less than 1% of all hip and femur fractures overall.

If you or a loved one has taken a bisphosphonate, including Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia, and Reclast, you may want to speak with an injury attorney. Contact the Law Offices of d’Oliveira & Associates today, regarding your potential drug lawsuit. A personal injury attorney may be able to help you get the compensation you deserve.

Fosamax linked to Osteonecrosis/Dead Jaw Syndrome

Bisphosphonates, like Fosamax, have also been linked to a serious bone disease called osteonecrosis of the jaw, also called “bone death.” This link was discovered by doctors at Long Island Jewish Medical Center (LIJ) in New York, in December of 2004 and published in the Journal of Oral and Maxillofacial Surgeons. In the study, a review of patient records revealed that all 63 patients diagnosed with osteonecrosis over a three-year period had received long-term bisphosphonate therapy. Most of these (57) were cancer patients who had received the intravenous bisphosphonates Zomenta and Aredia. About 10% were osteoporosis patients who had taken an oral bisphosphonate, mainly Fosamax. Doctors reported that each patient had developed osteonecrosis of the jaw (ONJ) after normal bone trauma, such as a tooth extraction.

Osteonecrosis of the jaw, or “bone death,” is a painful, disfiguring bone disease. Osteonecrosis of the jaw occurs when bone tissue in the jaw fails to heal after minor disturbances or procedures. In such instances, the bone tissue refuses to heal and begins to die. This condition may result in serious infection and fractures. Most patients require surgery to remove the dying bone tissue and diseased bone. Symptoms of “bone death” may include: numbness or heaviness in the jaw, other jaw pain, swelling of the gums, loose teeth, and exposed jaw bone, Osteonecrosis of the jaw has been linked to patients who have used large quantities of bisphosphonates. Such large dosages may be administered in some cancer treatment routines.

The American Association of Endodontists has released a position statement on the problem; “until further information is available, it would appear prudent to consider ALL patients taking bisphosphonates to be at some risk.” The discovery of the connection between osteonecrosis and Fosamax prompted the U.S. Food and Drug Administration, in March 2005, to conclude that the labels of all bisphosphonates should include information about the increased risk of osteonecrosis for patients taking Fosamax and other bisphosphonates.

PLEASE SPEAK WITH YOUR DOCTOR BEFORE DISCONTINUING THE USE OF FOSAMAX OR ANY OTHER PRESCRIPTION DRUGS.

Contact the Law Offices of d'Oliveira & Associates

If you believe that you or a loved one has suffered as a result of taking Fosamax or any other bisphosphonate, you may want to speak with a personal injury attorney. An injury lawyer familiar with new developments in the investigation of Fosamax and other bisphosphonates may be able to help you make important personal and legal decisions.

Please contact the law offices of d'Oliveira & Associates at 1-800-992-6878 or fill out a contact form for a free legal consultation.