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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 3 of 3. This is the beginning of the thread.
Posted by Phillipa on October 28, 2010, at 23:58:58
Two types of fractures. Affects all the biophosphinates. Glad to see the FDA finally stepped in. Phillipa
FDA Adds Femur Fracture Warning to Bisphosphonate Labels
Robert LowesAuthors and Disclosures
Posted: 10/13/2010
October 13, 2010 Bisphosphonates approved for the treatment of osteoporosis will now bear a label warning about the risk for 2 types of atypical femur fractures, the US Food and Drug Administration (FDA) announced today.One type of break, subtrochanteric femur fracture, occurs just below the hip joint. Another type, diaphyseal femur fracture, is in the long part of the bone. Both are very uncommon, accounting for less than 1% of all hip and femur fractures overall, according to the agency.
Risedronate sodium, alendronate
The FDA's decision to add a warning about the fractures to the labels of bisphosphonates comes in the wake of a recommendation to do so by a task force of the American Society for Bone and Mineral Research. In a report released last month, the task force said that of 310 cases of atypical femur fractures under study, 94% of the patients had been taking bisphosphonates, most for more than 5 years. The task force stopped short of declaring that the medications cause the fractures.The label change applies only to bisphosphonates approved for osteoporosis such as alendronate (Fosamax; Merck) and risedronate sodium (Actonel; Proctor & Gamble Pharmaceuticals). Bisphosphonates approved for the treatment of Paget's disease and high blood calcium levels caused by cancer are unaffected.
More information about today's announcement is available on the FDA's Web site.
To report adverse events related to bisphosphonates, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
Posted by ed_uk2010 on October 28, 2010, at 23:58:58
In reply to FDA Adds Warning to Biophospnates on 2 types femur, posted by Phillipa on October 13, 2010, at 20:00:11
Both types of atypical fractures are very uncommon. The bisphosphonates are still among the most useful treatments for osteoporosis.
Posted by 49er on October 31, 2010, at 10:37:55
In reply to Re: FDA Adds Warning to Biophospnates on 2 types femur, posted by ed_uk2010 on October 28, 2010, at 23:58:58
> Both types of atypical fractures are very uncommon. The bisphosphonates are still among the most useful treatments for osteoporosis.
Hi Ed,
As I mentioned in a previous thread, here is the problem I have with drugs, side effects, and doctors.
Many times, doctors will blow off side effects that are definitely associated with a drug like statins.
http://kendrive.blog.co.uk/2007/09/13/back_to_statins~2971602/
Sorry, this isn't the best link but the information you see is coming from the Washington Post and statistics are quoted. At one point, I had a direct link but of course, I can't find it.
Anyway, if doctors are routinely blowing off complaints about major side effects, then it seems that something that is listed as rare may be occurring more frequently.
Also, I saw a statistic that only 2 to 10% of all drug side effects are ever reported to the FDA so again, that makes me question whether something that is reported as rare actually occurs alot more often.
Not sure what the deal is in your area, the UK as an FYI.
Just so people know, I have never taken any of these drugs.
49er
This is the end of the thread.
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