FDA Issues Report With Caution On Long-Term Usage of Bisphosphonates
In mid-May, the FDA finally took a position on the controversial bisphosphonates prescribed as treatment for osteoporosis in postmenopausal women. (1) Of late the bisphosphonates class of drugs had been gathering an increasing amount of evidence of dire side effects in long term usage scenarios such as inflammatory eye diseases, osteonecrosis of the jaw, unusual fractures, irregular heartbeats as well as a steeped risk of esophageal and colon cancer. However, bone specialists had brushed these claims as rare and the possibilities of such occurrences ranging from anything between 1 in 10, 000 to 1 in 100,000 (2).
In a report issued by the FDA, the agency clearly stated that medical practitioners ought to practice caution in prescribing bisphosphonates class of drugs to women for the management of osteoporosis especially in the long run. It also stated that if the drug had been run for a period of 3 years or more for a senior female patient it was imperative that the situation be reviewed by her bone specialist. This was necessary to re-asses her bone mass and density situation. If the patient has been treated then she needs to get off the bisphosphonates and ensure she lives a healthy and active lifestyle and eats a well balanced diet rich in calcium and vitamin D. Continuing with bisphosphonates when the body does not require it harms the body and actually could cause fractures. (3)
Bisphosphonates are sold under the brand names Fosomax, Boniva, Reclast, Actonel, Evista, Zometa, Didronel, Aclasta and Skelid and are prescribed for osteoporosis as well as for Paget’s disease, multiple myeloma, bone metastasis and to those suffering from hypercalcemia (excessive calcium deposition in bones)
FDA’s findings on bisphosphonates are not new. Last year too the agency had voiced its concerns which it has repeated. In a nutshell, it said:
- Women who no longer have/ have recovered from, osteoporosis will not benefit from taking bisphosphonates.
- Bisphosphonates should not be taken beyond three to five years without having a review with your doctor.
- Postmenopausal women with lower than -2.5 T score may benefit from taking bisphosphonates beyond five years if their doctors so suggest.
- At any case, women should be periodically reassessed by their doctors to see if they need to continue bisphosphonates drugs.
Though there is no doubt that bisphosphonates are helpful in preventing millions of fractures in older women, it would be good if their doctors advise them to take it few years at a time. At the present moment there exists a lot of uncertainty around what is the optimal length of time a patient should take these drugs safely.
There have been successful clinical trials on bisphosphonates showing benefits to women when tried for a 5-year period, but for longer periods clinical trials have involved very small population and so the conclusions have been uncertain.
According to Dr. Rita Redberg, a professor of medicine at University of California at San Fransisco, “The problem is we don’t really know when to start or stop these drugs, and we don’t know how common those serious adverse events are. We think they’re uncommon, but we don’t really have strong data.”
- The Effect of Bisphosphonates as Treatment for Osteoporosis; Bellmore Patch – The Doctor Is In; Web May 2012; http://bellmore.patch.com/articles/the-effect-of-biphosponates-as-treatment-for-osteoporosis
- Bisphosphonates: The Good, The Bad, And The Unidentified; American Academy of Orthopaedic Surgeons; Web May 2012; http://www.aaos.org/news/aaosnow/dec11/clinical9.asp
- ABC News Video interview with Dr Richard Besser ABC News Chief Health and Medical Editor: FDA Still Cautious About Bone Drugs; ABC News; Web May 2012; http://abcnews.go.com/Health/fda-cautions-long-term-bone-drugs-osteoporosis/story?id=16321946#.T7nUZtxDv0c
Summary of the FDA report may be accessed at:
- Continuing Bisphosphonate Treatment for Osteoporosis — For Whom and for How Long?; The New England Journal of Medicine; Web May 2012; http://www.nejm.org/doi/full/10.1056/NEJMp1202623