A must read for biphosphoate users ...CAUTION

[RobinP]

JAMA June 28th issue sites the following article, "Reports of Adverse Events From Bone Drugs Prompt Caution", reports 2000 cases of osteonecosis of the jaw as a rare adverse event from taking biphosphonates, MOSTLY but NOT ENTIRELY as a result of high dose intravenous use as opposed from oral use. And it appears that jaw injury, poor oral hygiene or jaw injury percipitated this adverse event in biphosphonate users.

Wished I had a link to this article, but I only have the magazine here at home.If anyone subscribes online, please post the link. Below is another resource article on the same topic.It just seems there is never free lunch with any of these meds for breast cancer patients, very discouraging and displeasing to say the least.

Fosamax and Osteonecrosis
http://www.adrugrecall.com/fosamax/osteonecrosis.html

June 2, 2006

For a decade, millions of patients have been taking seemingly safe bisphosphonates to treat painful and debilitating bone conditions for metasicized cancer, osteoporosis, and Paget's disease. While this class of drugs has been on the market for a decade, research is now culminating to reveal the serious risk of osteonecrosis of the jaw (ONJ) associated with drugs like Fosamax .

Doctors, dentists, drug makers, medical researchers, and patients are now scrambling for answers to questions, many of which have no clear answers.

What is the risk of osteonecrosis caused by Fosamax?

While most experts agree the incidence of osteonecrosis among bisphosphonate users is rare, it is unclear the extent of the risk. Experts estimate that one to ten percent of the 500,000 cancer patients taking Fosamax or a related bone drug will develop osteonecrosis. Patients using lower doses of bisphosphonates for osteoporosis appear to be at a lesser risk, though know one appears able to quantify this risk.

What is clear is that dozens of bisphosphonate users have developed this painful and debilitating condition.

How are experts and consumers reacting to this risk?

Drug makers and medical groups are rushing to provide some answers, but so far, most of these are based on hunches, not scientific evidence. Doctors have been besieged by concerns from their patients about Fosamax and osteonecrosis risks. Some dentists are refusing to provide treatment to patients taking these drugs for fear that dental work will trigger this jaw-rotting disease.

Consumer legal advocates, plaintiff's attorneys, are investigating claims of those who have developed osteonecrosis due to bisphosphonates. At least 16 lawsuits have been filed against the various makers of bisphosphonates. The FDA has required additional osteonecrosis warnings on all bisphosphonates.

Patients want to know if they should stop or continue to take these medications. Some are avoiding any type of invasive dental work, such as tooth extraction, for fear of osteonecrosis. Patients want to know if osteonecrosis can be treated and what the prognosis would be. Some people have chosen to stop taking these medications until more answers are available. Firm data is, so far, rare to non-existent.

The Story of Fosamax and Osteonecrosis

Evidence of the connection between Fosamax and Osteonecrosis first surfaced with a 2003 letter to The Journal of Oral Maxillofacial Surgery , in which Dr. Robert E. Marx of the University of Miami reported 36 cases of osteonecrosis in cancer patients taking Fosamax or related bisphosphonates.

While experts were still speculative about these risks, another study followed, confirming this first report. Dr. Salvatore Ruggiero of the Long Island Jewish Hospital also found numerous cases of osteonecrosis among patients taking bisphosphonates in his own clinical experience.

While the first doctor reports of Fosamax and Osteonecrosis appeared in 2003, Novartis, the maker of one bisphosphonate, got its first patient report of osteonecrosis in December of 2002. This eventually prompted Novartis to voluntarily add warning labels to their medication, as more reports of osteonecrosis trickled in.

In 2004, Dr. Ruggiero discovered that patients taking bisphosphonates for osteoporosis were also at risk. He and his team published are report of 63 patients with osteonecrosis – 56 had cancer and seven had osteoporosis.

A recent article in the Annals of Internal Medicine included reports of 388 cases of osteonecrosis in cancer patients, 15 cases in patients with osteoporosis, and 3 cases in patients with Paget's disease. The researchers, medical experts from Harvard, estimate that the risk of cancer patients developing osteonecrosis from bisphosphonate use is between six and ten percent. The researchers did not quantify the risk for osteoporosis patients.

Osteonecrosis treatment and prognosis

So far, medical experts have found that cutting out decaying portions of the jaw in osteonecrosis patients only serves to make the condition worse . Patients using antibiotic rinses appear to have greater success with treatment endeavors. Many patients who have developed this condition have NOT been successful with treatment and live every day with a painful and deforming condition caused by their bone medication.

Other concerns

Many doctors indicate that they have long been concerned with the recommendation that patients take bisphosphonates for life . “The pharmaceutical industry has every desire that a patient who starts on a bisphosphonate would take it for life. The bone community, of which I am a member, has always been suspicious of that viewpoint,” contends Dr. Robert Gagel of Houston's M.D. Anderson Cancer Center.

Of additional concern is the length at which Fosamax and related drugs remain in the body after terminating treatment. Bisphosphonate drugs remain in the bone tissue for years and it is unclear what risks remain after terminating treatment. Some doctors and dentists say to stop using bisphosphonates for a few months to a year before dental surgery, though these are merely educated guesses about patient safety.

The Legal Consequences

Dozens of injured patients have pursued legal action against the makers of bisphosphonate drugs, alleging that the drug makers failed to adequately warn consumers about the potential risk of osteonecrosis. Merck, the makers of Fosamax , has been named as a defendant in 15 Fosamax lawsuits so far. Roche, who manufactures Boniva , has not reported any litigation against their company. Proctor & Gamble has been named in two lawsuits, one involving Actonel and one for Didronel . Novartis has refused to disclose information about litigation.

If you or a loved one has been injured by this medication, help may be available. You may be eligible to file a legal claim to seek compensation for your losses and suffering. If you would like to learn more, please contact us to speak with a qualified and experienced attorney who can answer your questions and determine the best way to protect your interests.


PS http://jama.ama-assn.org/cgi/content...urcetype=HWCIT

above is the link to the JAMA abstract. Note this is not the complete article.

http://www.adrugrecall.com/news/fosamax-danger.html

http://www.adrugrecall.com/fosamax/osteonecrosis.html