Fosomax

Fosomax History and Use

Fosomax is an oral drug designed, manufactured and distributed by Merck. It was first approved by the United States Food & Drug Administration (“FDA”) in September, 1995, and a generic version of Fosomax was approved in February, 2006. Fosomax falls within a class of drugs known as bisphosphonates. Fosomax is used for the treatment and prevention of osteoporosis in postmenopausal women and to increase bone mass with men with osteoporosis. It is also used in the treatment of Paget’s disease. Osteoporosis is a condition in which the loss of living bone tissue causes the bones to become more fragile. Osteoporosis can occur when a person experiences a significant decrease in Vitamin D and/or with estrogen depravation, and it is with and due to estrogen deprivation that post-menopausal women are especially at-risk for osteoporosis.

Bisphosphonates such as Fosomax are supposed to prevent osteoporosis by reducing the activity of osteoclasts in bone, which are cells that break-up bone tissue. Counter balancing osteoclasts are another specialized cell, osteoblasts, which develop bone tissue. Fosomax will decrease bone breakdown, but it simultaneously increases bone mineralization. As a result of this mineralization process, bone brittleness is also increased, resulting in increased risk of fracture. A further complicating factor is that the chemical nature of Fosomax also causes it to bind very tightly with bone tissue making a long lasting. Fosomax will remain biologically active for over ten years after a final dose is used.

Clinical studies and trials and other research have confirmed two injuries that can result from the long term use of Fosomax. The first is osteonecrosis of the jaw (“ONJ”). The second and more recently discovered injury from Fosomax usage is the occurrence of atypical femur shaft fractures.

Osteonecrosis of the Jaw

ONJ is the deadening of bone tissue in the upper and lower jaws. Because of the unique structure of the human jaw bone, Fosomax has been shown to inhibit vascularization in the jaw causing the jaw to die. ONJ is difficult to treat and is typically not reversible.

Throughout the 1990s and 2000s, medical articles and studies appeared reporting the frequent occurrence of ONJ from exposure to bisphosphonates used for chemotherapy. Reports of osteonecrosis of the jaw and other dental complications among users began surfacing. It was also learned that bisphosphonates, including Fosomax, inhibit endothelial cell function and inhibit vascularization and induce ischemic changes specific to patient’s mandibles (lower jaws) and maxillae (upper jaws).

Since Fosomax was released, the FDA has received a significant number of reports of osteonecrosis of the jaw among users of Fosomax. On August 25, 2004, the FDA released its ODS Postmarketing Safety Review on bisphosphonates - - specifically pamidronate (Aredia), zoledronic acid (Zometa), risedronate (Actonel), and alendronate (FOSAMAX). This was an epidemiologic review of the FDA adverse events database conducted by the FDA's Division of Drug Risk Evaluation. In its Review, the FDA observed that the risk of ONJ was not confined to bisphosphonates used for chemotherapy, rather ONJ was a side effect which resulted from the oral use of bisphosphonates, including Fosomax. The FDA recommended that the labeling for Fosomax be amended by Merck to specifically warn about the risk of ONJ.

Femoral Shaft Fractures

The second major side effect of long-term Fosamax use is femoral shaft fractures. A number of recent articles and different highly regarded medical and research journals have reported on findings that Fosomax users are at risk for developing atypical femur shaft fractures. A number of long term Fosomax users, typically women, have experienced spontaneous femur fractures; that is a fracture to the femur, or thigh bone, without any significant traumatic event. In some cases, women have experienced femur fractures simply by walking. Articles regarding the connection between Fosomax usage and these atypical femur fractures have been published in the Journal of Endocrinology and Metabolism, in the Journal of the American Medical Association and in the Journal of Clinical Endocrinology. The FDA has acknowledged the findings regarding the occurrence of femur fractures among Fosomax users and pointed a special Task Force to review the issue. The Task Force concluded that “There is evidence of a relationship between long-term use of bisphosphonates [which would include Fosomax] and a specific type of subtrochanteric femoral shaft fracture.”

Fosomax Litigation

Hundreds, if not thousands, of cases have been filed across the United States against Merck by Fosomax users that have suffered ONJ or femoral shaft fractures. Federal multi district litigation proceedings are pending in New York and Ohio – the New York MDL is focused on ONJ claims and the Ohio MDL is focused on femoral shaft fracture claims.

Foley & Small is representing clients who are Fosomax users who have suffered both ONJ and femoral shaft fractures. Foley & Small is sensitive of the experience of clients who have had to deal with the adverse side effects involving loss of living jaw bone and severe thigh fractures. Foley & Small is experienced in both state and federal court litigation involving defective pharmaceuticals, such as Fosomax and in the multi district litigation proceedings that have involved a variety of different defective drugs and medical implants, including Fosomax. Foley & Small would welcome the opportunity to help you or a family member dealing with the adverse side effects resulting from Fosomax usage.

Fosomax Complications – Contact Foley & Small

We’ve handled various cases involving defective pharmaceuticals, including pending Fosamax cases and others such as Vioxx, Digitek and Darvocet. We are experienced in handling such defective phamaceutical product claims both in federal and in state courts. We are dedicated to helping women who are dealing with symptoms and loses and heart ache that comes with dealing Fosamax complications. If you or a family member or friend is suffering from complications due to Fosamax use, contact Foley & Small.

You can call Foley & Small on our toll free number 800-276-2525, you can email us or you can complete new client contact form located to the upper right column of this page. A member of our office will contact you and we can begin steps to evaluate your case and provide needed help.