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 Gerry M. Kaye
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RESEARCH: "OSTEOPOROSIS DRUGS"BISPHOSPHONATES" CAUSING  CONCERNS"
Fosamax, Actonel, Boniva
with
"POSSIBLE ALTERNATIVES"

May 31, 2006 - Among the vast numbers of men and women, worldwide, of varied age groups who suffer from low bone density or Osteoporosis, a crippling disease that in advanced stages can turn bones brittle and susceptible to easy breakage, a recent finding is causing alarm that their commonly used medications for Osteoporosis may be risky.

Research finds that a growing number of physicians and oral surgeons are having concerns about jaw disease developing among long term users of a group of  "bisphosphonates," similar medications, some known as Fosamax, Actonel, & Boniva; relied on by many to reverse and control the damaged bone structures.

These concerns are that  "bisphosphonates", can lead to "dead jaw" syndrome, technically called "osteonecrosis", a word that literally means "dead bone" which is a painful condition that causes ulcers, tooth loss and exposed bone.

About 44 million Americans, almost 70 percent of them women, have osteoporosis. Fosamax, manufactured by Merck & Co., is the world's best selling osteoporosis medication. More than 22 million prescriptions were written for Fosamax in this country last year, according to pharmaceutical research firm IMS Health, and the drug has about $3 billion annually in sales.

Researchers say that osteonecrosis is "relatively rare", and seems most common among patients receiving intravenous bisphosphonates such as Zometa or Aredia in conjunction with chemotherapy or radiation for breast cancer and multiple myelomas. Incidents also appear more likely to follow serious dental surgery, such as a tooth extraction.

Dr. Bruce Pihlstrom of the National Institutes of Health said that cancer patients appear more at risk, while some patients taking standard oral
doses of bisphosphonates for osteoporosis also developed the "osteonecrosis," condition:

"Patients need to be aware of the risk," said Dr. Pihlstrom, a clinical research director specializing in dental and cranial-facial work. "If I was taking these drugs, I would make sure I had the best dental health care I could get."

The American Association of Endodontists, which deals with conditions inside the tooth, issued a statement several months ago, advising precautions for patients on such drugs and urging dentists to report all cases to the Food and Drug Administration. Dr. Pihlstrom said he so far knew of 368 reported cases.

"NEW RESEARCH IN THE WORKS"

Dr. Pihlstrom said that NIH plans to fund new research to quantify the potential risks of bisphosphonates.

In a statement released last month, Merck stated that "in all of our controlled clinical trials which have included more than 17,000 patients, we have not had reports of osteonecrosis of the jaw occurring in patients taking Fosamax."

The company said it complied with FDA requests last year and includes updates about osteonecrosis risk both in packaging inserts and product information sent to physicians.

But Dr. Michelle Fiorillo, a family physician with the Holy Cross Medical Group in Fort Lauderdale, doesn't remember seeing any such warnings and said the representative promoting Fosamax never mentioned them.

Now she says she's carefully monitoring her patients who have been on the medication for years.

Diagnosing a woman with osteoporosis this week, Fiorillo placed her on a low-dose estrogen patch instead of Fosamax when she learned the woman had dental problems.

Rochelle Kenig, who lives west of Boynton Beach, had no second thoughts about starting on Fosamax 10 years ago when a bone-density test showed she was in the early stages of osteoporosis.

In September 2004, Kenig began having excruciating pain in her right lower jaw. Her jaw swelled, and she developed an infection that required intravenous antibiotics. A maxillofacial surgeon finally told her in May 2005 that she had osteonecrosis.

Kenig's doctor told her to stop the Fosamax immediately.

Earlier this year, Kenig had a portion of her jaw removed, followed by a graft to fill a hole in her rotting jaw bone.

"I don't want this to happen to anyone else. And I'm angry it happened to me," said Kenig, 67.

Kenig is part of a class action lawsuit filed in U.S. District Court in Fort Myers last month by the law firm Levin Papantonio Thomas Mitchell Echsner & Proctor.

The Pensacola law firm also has filed some of the 10,000 lawsuits Merck faces over the painkiller Vioxx, which the manufacturer pulled from the market in 2004 after a study showed long term use of the drug increased the risk of heart attack and strokes.

The suit represents about 300 people nationwide, said attorney Timothy O'Brien. All were formerly on Fosamax and none were cancer patients.

The suit will ask the court to set up medical monitoring and pay for treatments and surgery for osteonecrosis patients.

The connection between jawbone death and bisphosphonate use is difficult to track, Fiorillo said, because it's physicians who prescribe the drug but dentists who treat the result.

And switching patients off bisphosphonates will do little good immediately, Fiorillo said, as the drug has a long half-life,  it can continue to effect the body's bone-building properties for six to 12 years, researchers think.

"This definitely is changing the way I prescribe for my patients with osteoporosis," Fiorillo said.

"POSSIBLE ALTERNATIVES"

When I telephoned  the "Drug Information" line, a pharmacist was kind enough to look up some possible alternatives to the "bisphosphonates" group of medications that instead of bisphosphonates, may effectively treat Osteoporosis. These are: "Evista", "Forted", "Estrogen" and "Miacalzin". The decision to make any changes for treatment should be thoroughly discussed with a physician.

References:
The "Drug Information" Telephone Line: 800-622-4728
.
An Article by Diane C. Lade - South Florida Sun-Sentinel- Posted May 20 2006
.
The Pharmaceutical Online Website

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Other NEWS Reports:
11/04/05-  Study-"Screening All Postmenopausal Women for Osteoporosis Recommended"
Park Nicollet Health Serv., Minneapolis - Screening all postmenopausal women for osteoporosis, or thinning of the bones, using bone densitometry and treatment of women found to have this condition is highly cost effective, regardless of age. "Even among the oldest of the elderly, bone densitometry and treatment of those with osteoporosis is worthwhile,.. & highly cost-effective and necessary if we are to make better progress reducing the health burden of osteoporotic fractures." said Dr. John T. Schousboe.
..
4/18/06  Study-"Side Effects Diminished In Cancer with "Evista" (Osteoporosis) Drug"
4/23/06  "Scientists "Reach The Summit" In Bone Disease Discovery"
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