FDA to Change Bisphosphonate Labels to Reflect Risk of Long-Term Use

A U.S. Food and Drug Administration (FDA) advisory panel recommended on Friday that osteoporosis drugs called bisphosphonates should now come with new and revised labels indicating the length of time it is safe to take the drugs. This suggestion comes on the heels of increased reports and studies indicating that long-term use of drugs such as Fosamax, Aclasta, Actonel, Altevia, Boniva and Reclast could lead to negative complications including osteonecrosis of the jaw and atypical femur fractures. According to CBS News, the FDA is comfortable with recommending that women cease taking these drugs at some point because there is growing research which demonstrates that because they remain in the bloodstream for some time that they could continue to be effective after use has ceased.

There is growing evidence that long-term use of bisphosphonates by females may carry an increased risk of atypical femur fractures, as well as osteonecrosis of the jaw.

Fosamax and other bisphosphonates have been used in osteoporosis patients because the drugs aim to improve bone density, but there is growing evidence that long-term use of bisphosphonates by females may carry an increased risk of atypical femur fractures, as well as osteonecrosis of the jaw. There is growing proof that, surprisingly, these drugs could actually make bones more brittle, not stronger. Atypical femur fractures occur when the long part of the thigh bone snaps, which can happen during low-energy exercise and is extremely painful. Osteonecrosis of the jaw literally means “death of the jaw,” where a loss of blood to bone tissue leads to the death of the tissue and the exposure of the jawbone.

It is reported by the FDA advisory panel that studies “suggest no significant advantage of continuing drug therapy beyond five years.” Accordingly, the FDA is expected to issue a revised label in November. According to the FDA, four million to five million Americans are prescribed bisphosphonates each year. This number accounts for the fact that about 11% of women over the age of 55 rely on the drug to fight osteoporosis. Nine percent of users take the drugs longer than three years, but less than one percent take them longer than five years. Manufactured by Merck, Fosamax alone boasts annual revenue of over $3 billion, with 37 million prescriptions written just in 2007.

If you or a loved one has experienced a fracture of the femur, osteonecrosis of the jaw, or other negative side effects believed to be connected to the use of Fosamax, you may be entitled to compensation for your suffering and medical bills. Though they are rare, the negative complications of long-term Fosamax and other bisphosphonate use are severe and debilitating. Contact a dedicated Fosamax femur fracture attorney to find out if you can pursue financial compensation. Complete the free case evaluation form on the right today for a no cost review of your claim.