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Tuesday, November 18, 2008

Bone Loss Problematic, Bone Drugs Risky

In January 2008 the FDA issued warnings regarding the class of drugs developed to allegedly help people with osteopenia and osteoporosis.

Numerous problems are associated with these drugs, including bone frailty and increased fracture rates.

Now chemotherapy for cancer seems to be opening a new window to ply these drugs on patients who already are health compromised because of the cancer and chemotherapy drug treatments.

It is interesting to note that there does exist a safe and effective approach to maintaining storng, healthy and flexible bones with vitamins and other natural supplements.

Some other physicians express concern -"
Bisphosphonates, like Fosamax and Actonel, are taken up by osteoclasts with resulting loss of osteoclast activity and inhibition of bone resorption, and bone remodeling (link). Although DEXA scanning confirms increased bone density and studies such as the FIT suggest reduced fracture rate, Susan Ott, MD raises questions about the long term safety of bisphosphonates. Although the bisphosphonates appear to have short term benefits, she speculates that after 5 years of use, there is severe suppression of bone formation with negative effects such as microdamage and brittleness.

Jennifer P. Schneider, MD, PhD reports a 59-year old previously healthy woman on long-term alendronate. While on a subway train in New York City one morning, the train jolted, and the woman shifted all her weight to one leg, felt a bone snap, and fell to the floor, suffering a spontaneous mid -femur fracture (see image). In the months following, it became clear that the fracture was not uniting. Schneider speculates that increased bone density from the bisphosphonate drug does not necessarily equate with good bone quality. By decreasing osteoclast activity and bone resorption, and therefore bone formation as well, microdamage, and brittle bone may result in fractures.

Odvina reports on 9 cases of spontanous fracture while on alendonate. Five of the nine cases were spontaneous mid femur fractures. Two had bilateral mid femur fractures same as Toulouse Lautrec. Six cases had delayed or absent fracture healing. Histomorphometric analysis of the cancellous bone showed markedly suppressed bone formation, and Odvina raised the possibility that severe suppression of bone turnover could develop during long-term alendronate therapy, resulting in increased susceptibility to, and delayed healing of, nonspinal fractures.

Dimitrakopoulos reports on 11 patients presenting with necrosis of the jaw, claiming this to be a new complication of bisphosphonate therapy administration, i.e. osteonecrosis of jaws. He advised clinicians to reconsider the merits of the rampant use of bisphosphonates. Osteonecrosis of the jaw is a common finding in pycnodysostosis. The bisphosphonates recreate the same clinical p rofile of spontaneous mid femur fractures, failure of bone healing and jaw necrosis which tormented Toulouse Lautrec.

In spite of this well known information, there are four more drugs in clinical trials which are specifically designed to inhibit cathepsin K, the enzyme defect in Lautrec's genetic bone disease. FDA approval for use in osteoporosis treatment is expected. Excuse me here, but perhaps this thinking needs re-evaluation. In essence we are creating a population of women with Toulouse Lautrec's bone disease. Ironically, women who sustain fractures while on Fosamax are told by their docs that the fractures are due to the underlying osteoporosis, not the drug. "

Cancer Treatment May Result In Bone Loss, Study Finds

ScienceDaily (2008-11-17) -- A new cross-Canada study has found that breast and prostate cancer treatment can foster bone loss. Scientists explain how loss of bone mass might affect 46,000 people diagnosed with breast and prostate cancer each year and place them at increased risk for osteoporosis and fractures. ... > read full article

FDA Issues Alert on Bone Drugs
By Elizabeth Trotta
The FDA posted an alert on Monday regarding possible severe, sometimes incapacitating bone, joint, and/or muscle pain in patients taking a class of bone-density drugs called bisphosphonates.
The possibility of such pain is listed in the drugs' prescribing information, but the FDA warned that doctors may overlook it to the point that it's prolonged or results in impairment, possibly requiring analgesics. This pain can occur days, months or years after initial use, and the risk factors for and incidence of severe musculoskeletal pain associated with the class are still unknown, according to the agency.

"Healthcare professionals should consider whether bisphosphonate use might be responsible for severe musculoskeletal pain in patients who present with these symptoms and consider temporary or permanent discontinuation of the drug," noted the health regulator in a Med Watch post on Monday.

The class of bone drugs in question include:

Proctor & Gamble's(PG Quote - Cramer on PG - Stock Picks) Actonel, Actonel +Ca, and Didronel

Novartis'(NVS Quote - Cramer on NVS - Stock Picks) Aredia, Reclast and Zometa

Roche and GlaxoSmithKline's(GSK Quote - Cramer on GSK - Stock Picks) Boniva

Merck's(MRK Quote - Cramer on MRK - Stock Picks) Foxamax, Fosamax + D

Sanofi Aventis'(SNY Quote - Cramer on SNY - Stock Picks) Skelid.

Drug companies downplay risks of bone-strengthening drugs for women
18.01.2008 Source: URL: -0

Drug companies exaggerate the benefits and downplay the risks of prescribing bone-strengthening drugs for women whose bones are weakened but who do not have osteoporosis, a new report claims.

Drugs such as alendronate and risedronate do reduce the risk of fractures of women with osteoporosis, according to the article in the Jan. 19 issue of BMJ.

Alendronate is a bisphosphonate drug used for osteoporosis and several other bone diseases. It is marketed alone as well as in combination with vitamin D (2,800 U and 5600 U, under the name Fosamax+D). Merck's U.S. patent on alendronate is set to expire in 2008 and Merck has lost a series of appeals to block a generic version of the drug from being certified by the U.S. Food and Drug Administration.

Risedronate sodium is a bisphosphonate used to strengthen bone, treat or prevent osteoporosis, and treat Paget's disease of bone. It is produced and marketed by Procter & Gamble and Sanofi-Aventis.

In January 2006 P&G and its marketing partner Sanofi-Aventis filed a Lanham Act false claims lawsuit against rival drugmakers Roche and GlaxoSmithKline claiming false advertising about Boniva. The manufacturers of Boniva, a rival bisphosphonate, were accused in the suit of causing a "serious public health risk" through misrepresentation of scientific findings. In a ruling on on September 7 2006 U.S. District Judge Paul A. Crotty rejected P&G's attempted injunction. P&G was criticized for attempting to "preserve its market share by denigrating Boniva". Judge Crotty wrote that "Roche was clearly entitled to respond with its own data, provided that the data was truthfully and accurately presented".

Source: «PRAVDA.Ru».


Anonymous said...

So what would you do if you had osteoporosis, given the real risk of death or loss of independence following a hip fracture? Rather than talk only about how risky the drugs are, should you not also talk about how risky osteoprosis is?

herbalYODA said...

I could very well write about how risky ostoporosis is however that is not the focus of this blog.

I don't underestimate the problem however patients and providers need to be aware that it is their due diligience that should come in to play in this or any other health concern.

Ostoporosis can be prevented through sound nutrition practices and it can be reversed with effective natural methods.

The point is to question autthority - meaning that you should ask yourself how did you get to the point where you had the diagnosis and and what dod your health care provider due to help you stay well before hand, and not give you drugs that really do make it worse in the end.