Call for Changes after Bisphosphonate Drugs Linked
to Fractures in Osteoporosis Patients
Bisphosphonates include the drugs Aclasta, Actonel,
Aredia, Bondronat, Boniva, Didronel, Fosamax, Fosavance, Reclast, Skelid,
and Zometa
Sept. 14, 2010 - A widely prescribed class of drugs
is highly effective in reducing common bone fractures in people with
osteoporosis, but an expert panel announced today that these same drugs
when used long term may be related to unusual but serious fractures
of the thigh bone. Ten million people in U.S. have osteoporosis, mostly
senior women. One out of two women and one in four men over 50 will
break a bone due to osteoporosis.
In the most comprehensive scientific report to date
on the thigh bone fractures, the task force reviewed 310 cases of
"atypical femur fractures," and found that 94 percent (291) of patients
had taken the drugs, most for more than five years.
The task force
members emphasized that atypical femur fractures represent less than one
percent of hip and thigh fractures overall and therefore are very
uncommon.
The task force was convened by the American Society
of Bone and Mineral Research the leading scientific organization on
bone science in the wake of growing concern about the connection
between these drugs, called bisphosphonates, and unusual femur
fractures.
The Food and Drug Administration (FDA) said in
March that it would await the report before making recommendations about
bisphosphonates and has received a copy of the task force's report. The
report was published in the Journal of Bone and Mineral Research.
"For the vast majority of patients with
osteoporosis, these drugs are an important weapon against fractures and
their benefits far outweigh the risks of using them," said task force
co-chair and lead author Elizabeth Shane, M.D., of Columbia University.
"Most of the patients who experienced these
atypical femur fractures had been taking bisphosphonates for more than
five years. However, we are concerned that there may be a relationship
between these fractures and long-term bisphosphonate use and, although
the risk is low, we want to make sure that people know about the warning
signs," she said.
The task force is calling for additional product
labeling, better identification and tracking of patients experiencing
these breaks, and more research to determine whether and how these drugs
cause the serious but uncommon fractures.
The international, multi-disciplinary task force
conducted an extensive review of both published and unpublished data and
interviewed scientists at pharmaceutical companies that sell the drug
and at the FDA, which maintains the MedWatch database that tracks
reported side effects of approved medications.
The task force expressed concern about the lack of
awareness of atypical femur fractures, their warning signs and their
association with long-term use of bisphosphonates. More than half of
patients with atypical femur fractures reported groin or thigh pain for
a period of weeks or months before fractures occurred, according to the
report.
More than a quarter of patients who experienced
atypical femur fractures in one leg experienced a fracture in the other
leg as well.
Millions of people, primarily women, have been
treated with bisphosphonates since they were approved in 1995.
Bisphosphonates include the drugs Aclasta, Actonel, Aredia, Bondronat,
Boniva, Didronel, Fosamax, Fosavance, Reclast, Skelid, and Zometa.
Bone diseases, such as osteoporosis, drastically
affect the way people function. Individuals who suffer broken bones as a
result of osteoporosis can suffer severe pain, loss of height and
stooped posture that can affect breathing and digestion. One in five
patients who walked before their hip fracture needs long-term care
afterward. And although the rate of hip fractures is two to three times
higher in women, after one year, the death rate in men is nearly twice
as high.
Among the task force recommendations:
● Product labeling should be changed to alert
health professionals and patients to the possibility of atypical femur
fractures for patients on bisphosphonate therapy and the associated
warning signs; cases should be reported to the FDA MedWatch program.
● New diagnostic and procedural codes should be
developed for atypical femur fractures to improve the quality of case
reporting and enable better review of medical records.
● An international registry of patients
experiencing atypical femur fractures should be established to track
cases and facilitate future research.
About Osteoporosis
Osteoporosis makes your bones weak and more likely to break.
Anyone can develop osteoporosis, but it is common in older
women. As many as half of all women and a quarter of men
older than 50 will break a bone due to osteoporosis.
Risk
factors include
●
Getting older
●
Being small and thin
●
Having a family history of osteoporosis
●
Taking certain medicines
●
Being a white or Asian woman
●
Having osteopenia, which is low bone mass
Osteoporosis is a silent disease. You might not know you
have it until you break a bone. A bone mineral density test
is the best way to check your bone health. To keep bones
strong, eat a diet rich in calcium and vitamin D, exercise
and do not smoke. If needed, medicines can also help.
"We know that bisphosphonates prevent many, many
common fractures. For this reason, we want to emphasize that patients
should not stop taking these drugs because they are afraid of the much
more uncommon femur fractures," Shane said.
They should talk to their health professionals
about their concerns and should let them know if they experience any new
groin or thigh pain. Patients can also report any side effects of these
medications to the FDA by phone or online.
She added, "Health professionals should reserve
bisphosphonates for patients with certain cancers, Paget's disease of
bone, and patients with osteoporosis who are at high risk of having a
fracture. Drug labels should include information about this side effect.
Although the risks are very low, health
professionals should know the warning signs of atypical femur fractures
and regularly ask patients on these drugs about groin or thigh pain.
They also should assess annually whether this therapy is appropriate for
each patient.
The task force report will be the topic of a
session at the ASBMR 2010 Annual Meeting in Toronto on Saturday, October
16 and is available at
www.jbmr.org.
About the Task Force
A full list of task force members and their
affiliations is listed below. All task force members were required to
disclose any potential conflicts of interest and their disclosures are
published as part of the task force report. To ensure the objectivity of
its findings, the task force included a physician and bioethicist with
expertise in conflict issues affecting biomedical researchers and a
scientist who does not work directly on osteoporosis or bisphosphonates
or with pharmaceutical companies that make or market bisphosphonates.
Additionally, the report underwent a rigorous peer review process prior
to its acceptance for publication by the Journal of Bone and Mineral
Research.
About ASBMR and the Journal of Bone and Mineral
Research
The ASBMR is a professional, scientific and medical
society that brings together clinical and experimental scientists
involved in the study of bone and mineral metabolism. The Society has a
hard-earned reputation for scientific integrity. The majority of the
Society's revenue comes from membership dues, fees paid to attend the
Society's annual meeting and subscriptions to ASBMR publications. Like
many scientific, professional, and medical organizations, ASBMR also
accepts grants from pharmaceutical companies, the federal government and
other entities to support its mission. To ensure that the Society
adheres to the highest ethical practices ASBMR has an ethics committee,
consults with experts in health care ethics and reviews its practices
with regard to managing potential conflicts of interest.
The Journal of Bone and Mineral Research is the
leading source worldwide for cutting-edge basic and clinical research in
the hormones that regulate bone and mineral metabolism and the treatment
of bone and mineral disorders.
LIST OF TASK FORCE PARTICIPANTS
Elizabeth Shane, Task Force Co-Chair, Columbia
University
David Burr, Task Force Co-Chair, Indiana University
School of Medicine
Bo Abrahamsen, Copenhagen University Hospital
Gentofte
Robert A. Adler, McGuire Veteran's Administration
Medical Center
Thomas D. Brown (Reviewer Scientist), University of
Iowa
Angela M. Cheung, University Health Network -
University of Toronto
Felicia Cosman, Helen Hayes Hospital
Jeffrey R. Curtis, University of Alabama at
Birmingham
Richard Dell, Kaiser Permanente Bellflower
David Dempster, Columbia University
Peter R. Ebeling, University of Melbourne
Thomas A. Einhorn, Boston Medical Center
Harry Genant, University of California at San
Francisco
Piet Geusens, Maastricht University Medical Center,
The Netherlands & University Hasselt, Belgium
Klaus Klaushofer, Hanusch Hospital Ludwig
Boltzmann Institute of Osteology
Kenneth Koval, Dartmouth-Hitchcock Medical Center
Joseph M. Lane, Hospital for Special Surgery
Fergus McKiernan, Marshfield Clinic
Ross McKinney (Ethicist), Duke
University School of Medicine
Alvin Ng, Singapore General Hospital
Jeri Nieves, Helen Hayes Hospital
Regis O'Keefe, University of Rochester Socrates
Papapoulos, Leiden University Medical Center
Howe Tet Sen, Singapore General Hospital
Marjolein C.H. van der Meulen, Cornell University
Robert S. Weinstein, University of Arkansas for
Medical Sciences
Michael Whyte, Shriners Hospital for Children
Keep up with the latest news for senior citizens, baby
boomers
Sept. 14, 2010 - A widely prescribed class of drugs
is highly effective in reducing common bone fractures in people with
osteoporosis, but an expert panel announced today that these same drugs
when used long term may be related to unusual but serious fractures
of the thigh bone. Ten million people in U.S. have osteoporosis, mostly
senior women. One out of two women and one in four men over 50 will
break a bone due to osteoporosis.
