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Bone drug may hold hazards

Doctors raise concerns over use of Fosamax

May 20, 2006 | South Florida Sun-Sentinel

Millions of midlife and older Americans rely on the medication Fosamax to stave off osteoporosis, a crippling disease that turns bones so brittle that someone can break a hip just by walking around inside the house.

But a growing number of physicians and oral surgeons have raised concerns that the long-term use of Fosamax, and similar so-called "bisphosphonates," can lead to "dead jaw" syndrome, a painful condition that causes ulcers, tooth loss and exposed bone.

Researchers say cases are rare and seem 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.

But while cancer patients appear more at risk, Dr. Bruce Pihlstrom of the National Institutes of Health said some patients taking standard oral doses of bisphosphonates for osteoporosis also developed the condition technically called "osteonecrosis," a word that literally means "dead bone."

"Patients need to be aware of the risk," said 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."

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

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. Pihlstrom said he so far knew of 368 reported cases.

About 44 million Americans, almost 70 percent of them women, have low bone density or 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.

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. The suit represents about 300 people nationwide. 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.

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.

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.

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