Fosamax

Motley Rice is investigating cases involving individuals who have suffered serious injury or wrongful death after use of Fosamax.

Fosamax is a bisphosphonate drug that is marketed, advertised, distributed and sold for the treatment of osteoporosis and Paget's Disease. This drug is manufactured by Merck and has additionally been prescribed for off-label uses for conditions such as bone cancer.

Symptoms

Symptoms associated with the use of Fosamax can include:

  • osteomyelitis: inflammation of bone marrow
  • osteonecrosis of the jaw (ONJ): a condition also known as dead jaw disease, jaw death, bisphossy jaw, and avascular or aseptic necrosis of the mandible/maxilla

ONJ is a painful and disfiguring condition resulting from infection of the jaw and exposed portions of bone inside the mouth, causes the jaw bone to decay and die. 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 that exposes jaw bone. While almost all cases of ONJ have occurred following dental work, several cases have been reported as having occurred in the absence of dental work when bone is exposed and subject to infection.

If you or a loved one may have experienced any of the above symptoms, contact attorney Fred Thompson or Carmen Scott by email or call +1.800.768.4026.

Drug History and Serious Adverse Reactions

The FDA approved Fosamax tablets on September 29, 1995 and the oral solution 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 used in chemotherapy but are not indicated for use in non-cancerous conditions like osteoporosis.

Throughout the 1990s and 2000s, medical articles and studies reported the frequent and common occurrence of ONJ following the use of nitrogenous bisphosphonates used for chemotherapy. Because Merck reported and acknowledged side effects concerning irritation, erosion, and inflammation of the upper gastrointestinal tract, we believe this manufacturer 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.

In addition, we believe Merck knew or should have known that bisphosphonates also inhibit the development of blood vessels in an organism or tissue of an affected area, resulting in an inadequate supply of blood, specifically to patients' lower jaws and upper jaws. As a result, a minor injury or disease can turn into a non-healing wound that may then progress to widespread bone death and inflammation of bone marrow.

An article about bisphosphonate-associated osteonecrosis of the jaw in the Oregon Dental Association's March 2006 newsletter cites 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. The article uses the term bisphosphonate-associated osteonecrosis of the jaw (BONJ).

Some state dental associations are now advising dentists to refrain from using any invasive procedure, such as drilling a cavity, on any patients who are taking Fosamax. Once osteonecrosis begins and becomes symptomatic, it is very difficult to treat and is not reversible.

On January 7, 2008, the FDA issued an alert regarding the possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain in patients taking bisphosphonates. The alert said that severe musculoskeletal pain may occur within days, months, or years after starting a bisphosphonate.