Popular medications for bone health is raising concerns from the FDA
On Friday two advisory panels for the U.S. Food and Drug Administration will meet to examine the safety of the well known osteoporosis medications called bisphosphonates such as “Fosamax”. Concerns raising long term usage of the drugs which could cause rare fractures of thigh bones and death of jaw bone.
It is expected that both FDA staff members and the panels will be conducting an extensive review of safety of medical evidence to current date. Depending on the recommendation it may affect around four million women in the United States who are currently using these medications.
The FDA has confirmed this meeting and has stated more information will become available on Wednesday on their website. The question as if women should stop using these drugs on a temporary basis or using them just for a couple of years will be evaluated according to the Wall Street Journal.
Just towards the end of last year it was reported that Loyola University Health System had advocated taking a drug break from some of these medications. The University also had noted at that time that those popular bone drugs like Fosamax and Boniva could result in fractures in thigh bones and decay of tissue in jaw bone.
Another report also had come out last year in September by American Society of Bone and Mineral Research. The report had associated these drugs in which included the generic forms to rare femur fractures among patients with osteoporosis. At that time it was recommended that the FDA review these medications.
If that was not enough in February a study had appeared in the online edition of the Journal of the American Medical Association which had found that taking these medications for a time span of five years or more was associated to a 2.7 times of higher risk of hospitalization for uncommon fractures of the femur compared to lower rates of usage of these medications.
In July, an announcement had come from the FDA that it would convey a joint meeting of advisory committees for the drug safety and reproductive health to reconsider these medications after proof had emerged associating long term use of these drugs with fractures in the femur or thigh bone, death of the jaw bone and a possible association to esophageal cancer.
Merck spokesperson Ronald Rogers had stated the company in responding to two questions presented by the FDA. One is whether these drugs have proof of being safe and effective for long term use and the other poses the question of either restricting or requiring a break from taking these medications. Merck has plans on issuing a report later on this week.
FDA spokesperson Jeff Ventura would only comment that the will discloses its questions concerning these drugs and staff report maybe on Wednesday.
In October, the FDA did order a warning label to be placed on these drugs about the small increased risk of femur fractures. In 2005, one had been added about raw jaw disease from these drugs.
The main issue at present facing the FDA and the advisory committees is to either order a stronger warning on these drugs or ban long term use. The FDA is recommending for women to continue these drugs until at which time a safety review has been completed.
Dr. Susan M Ott, associate medical professor and bone specialist at the University of Washington had remarked that her own personal opinion that in most cases after five years the drugs should be stopped due to mounting evidence of risk and no proven benefits after that time frame. She further notes the longest time anyone should take these drugs is a period of fifteen years.
Merck is currently faced with an estimated 1,115 lawsuits concerning jaw damage and another 535 cases over femur fractures and other
Last year Judith Graves a 67 year old retired investigator for the Unites States Army had made news when she went forth with a civil trial and sued Merck. Ms. Graves who had taken Fosamax had suffered bone death in her jaw. She had to under go five major operations which had included a long surgery to replace her broken jaw with bone from her left arm.
Fosamax has also been associated to severe muscle pain.
There are several alternative therapies available to aide with osteoporosis. Here are just two of them.
Chiropractic
Regular visits to your chiropractor can provide pain relief from this disease. These treatments also boost the immune system, raise bone density, and maintain mobility and range of motions which helps in fall prevention. If you have osteoporosis make sure you inform your chiropractor as each treatment is geared to the individual. Chiropractors are trained in the area of this disease.
Acupuncture
Treatments from your acupuncturists just may give you beneficial outcomes to prevent this disease. Certain points used can enhanced bone tissue growth and even replace tissue loss fast to prevent decrease in bone density.
Sources:
New York Times
ABC News
Detroit Examiner