On January 7, 2008, the Food and Drug Administration (FDA) informed physicians about the possibility of an adverse event reported in some patients taking bisphosphonates. There have been rare reports of bone, joint and/or muscle pain, sometimes very severe, occurring within days, months, or even years after starting one of the bisphosphonates (Fosamax®, Actonel®, Boniva®, and Reclast®) for osteoporosis. The FDA issued this notice in order to provide information to physicians and healthcare practitioners to help them manage their patients who experience these symptoms.

In nearly all reported cases, pain is relieved when the bisphosphonate therapy stops. Discomfort resolves within a few days after the drug is stopped, but may last as long as a week and in rare cases, much longer. In a few cases, when the bisphosphonate therapy restarts, the pain returns. The pain is quite severe and should not to be confused with the many aches and pains suffered by people that come and go during life.

What do we know?

Bisphosphonates are the mainstay of treatment and prevention of osteoporotic fractures, with as many as 191 million prescriptions written (Source: MS HEALTH, NPA Plusâ?¢ May 2006).

Presently, there is no known method to distinguish between these symptoms and other causes of pain in patients with osteoporosis. Physicians should recognize this set of symptoms, and if it occurs, first stop the bisphosphonate and evaluate to see if the pain eases before ordering expensive and uncomfortable evaluations. Physicians should not consider this syndrome as a contraindication to beginning treatment of osteoporosis with bisphosphonates. However, if severe bone pain occurs in patients taking bisphosphonates, the drug should be stopped for a period to evaluate the response. NOF believes the benefits of bisphosphonate treatment in patients at risk of osteoporotic fracture strongly outweigh the risks from treatment. Serious long-term disability and death are significant consequences of osteoporotic fractures.

Summary

Patients who take bisphosphonates should report severe and long lasting pain to their physician and discuss whether treatment should be stopped.

Patients should discuss their medication concerns with their healthcare providers.

Physicians of patients who report severe and long lasting bone pain while on bisphosphonates should discontinue bisphosphonates for a period of time until the pain symptoms resolve.