Investigations

Fosamax and Osteonecrosis of the Jaw (ONJ) Warnings

The original Fosamax warning label issued by Merck in 1995 failed to include any warning that Fosamax may cause jaw bone decay or death. However, after a story published by the Journal of Oral and Maxillofacial Surgeons uncovered that many patients suffering from Osteonecrosis of the Jaw (ONJ), an extremely painful and irreversible jaw bone disease, were also taking Fosamax, the FDA initiated an investigation into Fosamax’s adverse side effects. In January 2005, the FDA recommended that Merck revise the Fosamax warning label to include a warning that Fosamax may be related to ONJ. While Merck eventually complied with the FDA’s request to update the Fosamax warning label, Merck did not issue the new warning label until several months later. In addition to asking Merck to revise its Fosamax warning label, the FDA has asked all bisphosphonate manufacturers to include a new warning in the medication warning label about the possible link between bisphosphonates and ONJ.

Fosamax and Bone, Joint & Muscle Pain Warnings

In addition to ONJ, Fosamax has been known to cause severe bone, joint, and muscle (musculoskeletal) pain in same patients. Although Fosamax’s labeling includes a warning that severe musculoskeletal pain is a possible adverse effect caused by the drug, the FDA has stated that healthcare professional could easily overlook the link between Fosamax and severe musculoskeletal pain. The FDA says this could result in delayed diagnosis and prolonged pain, causing physicians to unnecessarily prescribe pain relieving medications. As a result, the FDA recently issued a health alert warning physicians to be aware that Fosamax use could be responsible for severe musculoskeletal pain in patients suffering from this symptom. 

Fosamax and Chronic Heart Condition, Atrial Fibrillation Warnings

According to a new warning, Fosamax may be related to the chronic heart condition, known as atrial fibrillation, which causes a recurring irregular heart beat. In fact, a study suggests that women who use Fosamax may be twice as likely to develop atrial fibrillation as women who do not use bisphosphonates. Atrial fibrillation occurs when a problem with the heart’s electrical system causes the atria to quiver, or fibrillate. The quivering interrupts the normal rhythm between the heart’s upper and lower chambers, which may cause the heart to beat fast and irregularly. While atrial fibrillation usually is not life threatening, the condition can lead to more serious heart problems such as stroke, heart failure, and heart attack.

If you or someone you love has been affected by Fosamax related side effects and you’d like to more about your legal rights, contact our lawyers today.