FDA Questions Long-Term Safety of Osteoporosis Drugs

The Food and Drug Administration estimates that over 10 million Americans are affected by osteoporosis, a condition which involves progressive weakening of the bones and can result in easy injury, particularly in the elderly. Women are at a particular risk of developing the disease. A class of bone drugs called bisphosphonates have been widely prescribed to slow the loss of bone mass, with more than 150 million prescriptions issued between 2005 and 2009 to help promote bone growth and reduce the risk of fractures.

And new data from the FDA suggest that these drugs, known by the brand names Fosamax, Boniva, and Reclast, may be doing more harm than good with long-term use. In rare cases, using the drugs for more than 3-5 years can result in serious adverse events, including unusual femur fractures, esophageal cancer, and osteonecrosis of the jaw – a condition which causes painful, disfiguring crumbling of bone.

These kinds of serious complications are worrying but rare. Unfortunately, no is sure exactly how rare – estimates for the rate of bisphosphonate-related fractures range from 1 in 10,000 users to 10 in 10,000. Some are calling for more research to be done on whether the drugs are safe  - and wondering why a drug with such dangerous potential side effects was given such quick approval.

The more important implication of the study is the finding that most patients don’t benefit from long-term use of these drugs either way. In wake of this news, experts consulted by the New York Times predict that many doctors will probably stop prescribing bone drugs to their patients, resulting in anywhere from 60-70% of those currently taking the drugs going off them.

Unfortunately, the FDA hasn’t issued any specific guidelines for safe long-term use yet. Some patients with osteoporosis may continue to benefit from use of bisphosphonates long-term, and the risks versus benefits need determined on a case-by-case basis.

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Photo credit: Asja Boros

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Elisa Faulkner- Uriarte
Elisa F.2 years ago

Scary stuff...thanks for keeping us informed.

Charlotte A.
Charlotte A.3 years ago

Ever since the "revolving door" problem began, around the Reagan-Bush administrations, we haven't been able to trust what the FDA says. What is meant by the revolving door is that a former CEO of a drug company gets a position of power in the FDA. This is a conflict of interest, and shouldn't be allowed. However, here we are with the sad consequences being that the new drugs are being sent to market without proper testing.

Debbie L.
Debbie Lim3 years ago

It's better to prevent it from happening than to wait until you have this disease and then ask for medicine. There are lots of vitamins and supplements that can help and eating the right food is obviously a must.

Phil Konigsberg
Phil Konigsberg3 years ago

To Jane B. - Your comment:"Take this if you want to die before your time cause it
will kill you." For a moment I thought you were referring to a statement that should be on any tobacco product that is manufactured and sold to the public.

Claire M.
Claire M.3 years ago

I used to have burning aching sensations in my bones [especially back and hips] when I stopped taking hypertension medication it went away. Been though a bunch of doctors over the last 9 years and none of them will listen to the side effects I report and take them seriously [above being only one of many]. Then I started researching on my own and found I was not as unique as I was being told by my doctors and that a lot of side effect reporting is not making it back to the FDA.

Its not just the FDA, it isn't just the drug companies, there is a dangerous flaw in the entire medical system that has evolved over the years. Most doctors work for large corporations also and we need to pressure those corporations to allow their doctors to be more honest. What we have is a system where one long term [or life long management drug] is causing problems leading to other drugs and so on and so on. If you step back it actually looks like we are being harvested for the drug money. No wonder the vitamin and supplement industry is under attack, its competing with the drug management system. Unfortunately the drug management system might not be too concerned with your vitality and longevity.

Research before you use please [I wish I had], your doctor is not always your savior

J.L. A.
JL A.3 years ago

So scary that the FDA apparently uses the same procedures to approve a drug intended for short term use as for long term use--and the expected negative consequences to public and individual health as a result...we and our doctors should be able to trust the FDA more than this tells us

Terry Vanderbush
Terry V.3 years ago

Why are the DRUGS available then? Who is NOT being accountable for THEIR actions? JEEZ.........

Mary Mattarelli
Mary Mattarelli3 years ago

Every Prescription drug can have nasty side effects. Thats why I dont take any prescription drugs. I treat myself with all natural products and a healthy diet..

Billie C.
Billie C.3 years ago

nimue i have copd and there is no cure.

Edith B.
Edith B.3 years ago

First we are told we need these drugs to keep from having fractures, now they are saying they can potentially kill us or cause fractures. How well are drugs investigated before being sold to us? Apparently not very well.