The United States Food and Drug Administration (FDA) is highlighting the possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain in patients taking bisphosphonates. Although severe musculoskeletal pain is included in the prescribing information for all bisphosphonates, the association between bisphosphonates and severe musculoskeletal pain may be overlooked by healthcare professionals, delaying diagnosis, prolonging pain and/or impairment, and necessitating the use of analgesics.

The severe musculoskeletal pain may occur within days, months, or years after starting a bisphosphonate. Some patients have reported complete relief of symptoms after discontinuing the bisphosphonate, whereas others have reported slow or incomplete resolution. The risk factors for and incidence of severe musculoskeletal pain associated with bisphosphonates are unknown.

This severe musculoskeletal pain is in contrast to the acute phase response characterized by fever, chills, bone pain, myalgia (means MUSCLE PAIN) , and arthralgia (means JOINT PAIN) that sometimes accompanies initial administration of intravenous bisphosphonates and may occur with initial exposure to once-weekly or once-monthly doses of oral bisphosphonates. The symptoms related to the acute phase response tend to resolve within several days with continued drug use.

Healthcare professionals should consider whether bisphosphonate use might be responsible for severe musculoskeletal pain in patients who present with these symptoms and consider temporary or permanent discontinuation of the drug.

This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this when additional information or analyses become available.

Larry's Comments:

Health care professionals who take the time to research the drugs they might prescribe soon find that all is not as nice and tidy as the drug makers would like them to believe. I've been campaigning against the use of bisphosphonates for years - and so have scores of my colleagues.

Some people listen to us and shun these potentially very harmful drugs. For example, I met a lady (in her 70s) who told me her doctor ordered Fosamax for her every time she had an appointment. She said she always thanked him, folded the prescription and threw it away after she got back home. She never had it filled - for all the right reasons but her doctor didn't know. He happily prescribed it over and over thinking that the drug was working.

Sadly, the vast majority of doctors believe the tripe they're fed by the drug company sales force. There are all sorts of reasons why they believe so completely, but I won't bore you with all that here. I must point out that I believe the doctors really believe they're doing the right thing. I just think it's a shame they decided to let someone do their thinking for them - instead of using the education they paid so dearly for. 

Here's the summary: bisphosphonates will NOT improve osteoporosis - AND - they can do far more harm than good. Nobody needs them. There are far better ways to prevent bone fracture - and they don't demand the use of drugs. Osteoporosis is NOT a drug deficiency.

Here are a few references from our website; Dr. Filice & Osteoporosis, Bone Mineral Density by Dr. John Abramson, About Osteoporosis, Fractures & Bone Mineral Testing