When the FDA held a hearing on the safety and effectiveness of long-term use of osteoporosis drugs last fall, we spoke up and said that women needed to know that studies were starting to show that long-term use might not be safe. We asked the FDA to tell women that using bisphosphonates for more than 3-5 years does not help women, and might be harmful. Just last week we wrote the FDA and again asked them to go one step further and tell women and their health care providers that these drugs should no longer be used for prevention of osteoporosis.
In an article published on-line in the New England Journal of Medicine, FDA officials took an important step in this direction. They explained that long-term studies of women taking three different types of bisphosphonates (Fosamax, Actonel and Reclast) showed that continuing to take the drugs beyond five years didn’t reduce the risk of fracture. Other studies show that some women taking bisphosphonates experience serious complications, including jaw bone decay and unprovoked broken legs. These complications are rare, but the FDA recognized that they are so serious that they tip the risk/benefit ratio against using the drugs longer than 3 to 5 years.
NWHN agrees with the FDA that long-term use of bisphosphonates isn’t helpful for most women, and urges women and their clinicians to seriously consider stopping these drugs after 3-5 years. Are there some women who should continue bisphosphonates beyond 3-5 years? There is no conclusive proof that long-term use of the drugs helps any women, but the FDA and many researchers believe that women whose bone density is still very low and who have already experienced a hip, wrist or vertebral fracture with symptoms might benefit from staying on bisphosphonates beyond 5 years. We will advocate for more studies to answer this important question.
Now that the FDA has acknowledged the problems of long-term use of these drugs, it should take the next step and address the important question – Which women should start taking bisphosphonates in the first place? We have urged the agency to change its recommendations to end the practice of prescribing bisphosphonates to healthy women for prevention. Too many women are handed a prescription for bisphosphonates after getting a bone density scan that shows normal age-related bone loss, even though they have no other risk factors for fracture. Those women are very unlikely to have a serious fracture in the next few years – and taking bisphosphonates isn’t likely to do them any good.
We applaud the FDA for making a very public announcement about long-term use of bisphosphonates. It’s going to take a major effort for women and their clinicians to un-learn the lessons taught to them by overly aggressive marketing of bisphosphonates. But protecting women from unnecessary harm is worth the effort. We’ll do our part getting the word out to women; starting with our factsheet, with an updated one to come. You can help us by forwarding this message to your friends, and encouraging them to join us by becoming a member of the Network. Click here to find out how!