June 27, 2012 — The FDA is warning consumers to only use bisphosphonate osteoporosis drugs for three to five years. Millions of people use this popular class of drugs, including Fosamax, Boniva, Acontel, Atelvia, and several generics.
After the FDA reviewed clinical safety studies, they found that there is little information on the safety or effectiveness of long-term use of these drugs. The New England Journal of Medicine published the results of the FDA study on May 31, 2012.
Osteoporosis is a condition that occurs when bones disintegrate faster than the body can repair them. Over times, the bones gradually become weaker, more brittle, and are more likely to break. Approximately 44 million Americans are at risk of developing osteoporosis as they age.
Scientific studies have clearly established that bisphosphonates are effective at preventing bone fractures when the drugs are taken for three to five years, but there have been no studies on the long-term risks and benefits of bisphosphonates. Even so, many people use these drugs for many years.
The FDA is now recommending that bisphosphonate users limit their use of the drugs to 3-5 years, but the long-term benefits of the drug may continue even after the drugs are stopped. Bones are constantly dissolving and re-forming. Over time, bisphosphonates incorporate themselves into the bones being formed. They could, potentially, provide anti-fracture bone protection for several years after the drugs are discontinued. However, more studies need to be conducted to better understand the long-term effects.
One reason why the FDA wants to limit the use of bisphosphonates is because they have been linked to several severe side effects. One is osteonecrosis of the jaw (ONJ), in which the jaw decays severely and can become infected, necessitating removal of the jaw bone. Bisphosphonates may also increase the risk of spontaneous femur fractures, which can be very painful and debilitating. The FDA updated the labels on bisphosphonates to warn of these risks in October 2010.
Hopefully, more studies in the future will increase awareness about the long-term safety profile of the bisphosphonate class of osteoporosis drugs. One FDA medical officer warned, “We just don’t know yet the optimum period of time individuals should be on the drug to both maximize its effectiveness and minimize potential risks.”
The FDA is recommending that current patients talk to their doctors about the risk-benefit of using a bisphosphonate. Furthermore, patients should periodically meet with their doctor to re-evaluate whether to continue bisphosphonate drug therapy.