Fosamax® (alendronate sodium tablets and oral solution) is a bisphosphonate manufactured by Merck, that is marketed, advertised, distributed and sold for the treatment of osteoporosis and Paget’s Disease. It has additionally been prescribed for off label uses such as bone cancers. Fosamax® tablets were approved by the FDA on September 29, 1995, while the oral solution was approved on September 17, 2003. Fosamax® is in the non-nitrogenous class of bisphosphonates, meaning it contains a nitrogen atom. Other drugs within this class such as Aredia® and Zometa® are also used as chemotherapy, but are not indicated for use in non-cancerous conditions such as osteoporosis. The Physician’s Desk Reference (PDR) for Fosamax® confirms that the molecule contains a nitrogen atom.
Serious Adverse Reactions
Throughout the 1990s and 2000s, medical articles and studies reported the frequent and common occurrence of osteonecrosis of the jaw with the use of nitrogenous bisphosphonates used for chemotherapy. As with its reported and acknowledged side effects concerning irritation, erosion, and inflammation of the upper gastrointestinal tract, we believe Merck knew or should have known that Fosamax®, as a nitrogenous bisphosphonate, shared an adverse event profile similar to that of the other drugs within this specific subclass of bisphosphonates. Similarly, we believe Merck knew or should have known that bisphosphonates also inhibit the development of blood vessels in an organism or tissue of the affected area, resulting in an inadequate supply of blood, specifically to patients' mandibles (lower jaws) and maxillae (upper jaws), appearing to be cumulative in nature. As a result, a minor injury or disease can turn into a non-healing wound. That in turn can progress to widespread necrosis (bone death) and osteomyelitis (inflammation of bone marrow).
More recently, an article about bisphosphonate-associated osteonecrosis of the jaw in the Oregon Dental Association’s March 2006 newsletter cited an increasing number of complications associated with the use of bisphosphonate drugs, and specifically names Fosamax® as being “associated with development of a disorder involving non-healing, necrotic exposure of bone in the jaws” and uses the term “bisphosphonate-associated osteonecrosis of the jaw” (BONJ).
Dentists are now being advised by some state dental associations to refrain from using any invasive procedure (such as drilling a cavity) for any patient on Fosamax®. Once osteonecrosis begins and becomes symptomatic, it is very difficult to treat and is not reversible.
In an October 2007 Early Communication of an Ongoing Safety Review, the FDA issued the following statement regarding Fosamax®:
“An article and an accompanying letter to the editor in the May 3, 2007, issue of The New England Journal of Medicine describe increased rates of serious atrial fibrillation (defined by the authors as life-threatening or resulting in hospitalization or disability) in two different studies of older women with osteoporosis treated with the bisphosphonates, Reclast and Fosamax. In both studies, more women who received one of the bisphosphonates (Reclast-1.3% or Fosamax-1.5%) reportedly developed serious atrial fibrillation as compared to women who received placebo (Reclast study-0.5%, Fosamax study-1.0%).”
On January 7, 2008, the FDA issued the following alert regarding bisphosphonates:
“FDA is highlighting the possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain in patients taking bisphosphonates….The severe musculoskeletal pain may occur within days, months, or years after starting a bisphosphonate. 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.”
Symptoms associated with the use of Fosamax® can include:
• Osteonecrosis of the jaw (ONJ) also known as dead jaw disease, jaw death, bisphossy jaw, and avascular or aseptic necrosis of the mandible/maxilla. This painful and disfiguring condition causes the jaw bone to decay and die as a result of infection of the jaw and exposed portions of bone inside the mouth. Symptoms may take weeks or months to become evident, and may develop following trauma to the tooth, such as an extraction, or other dental surgery performed exposing jaw bone. While almost all cases of ONJ have occurred following dental work, several cases have been reported to occur in the absence of dental work where bone is exposed and subject to infection.
Jon L. Gelman LLC is investigating cases in which individuals suffered serious injury or wrongful death after use of Fosamax®. If you or someone you know has experienced any of the foregoing symptoms, call Jon L. Gelman at 1-973-696-7900.
FDA Alert March 2008
FDA Alert January 2008
Oregon Dental Association’s March 2006 newsletter
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