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Fosamax may do more harm than good

Millions of Americans rely on the medication Fosamax to stave off osteoporosis, a crippling disease that turns bones so brittle that someone can break a bone by doing normal everyday activities.

However a growing number of physicians and oral surgeons have heightened concerns that the long-term use of Fosamax, and similar "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 various types of cancer. In addition, 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 while cancer patients appear more at risk, 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 with hopes to determine a more accurate conclusion of 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 the U.S. last year alone, according to pharmaceutical research firm IMS Health, and the drug has about $3 billion annually in sales.

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

In September 2004, however Kenig began having excruciating pain in her right lower jaw. Her jaw swelled with 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 taking 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 recently filed in U.S. District Court in Fort Myers, Florida against Merck & Co., manufacturer of Fosamax. Merck & Co. also faces thousands of lawsuits over its 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, all of who were formerly on Fosamax for conditions other than cancer.

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

In a recent statement, 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 recall ever seeing any such warnings and said the drugmaker’s representative promoting Fosamax never mentioned them.

Now she says she's closely monitoring her patients who have been on the medication for years. Recently, she diagnosed a woman with osteoporosis and placed her on a low-dose estrogen patch instead of Fosamax when she learned the woman had dental problems too.

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

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

Millions of Americans take bisphosphonates, such as Fosamax and Actonel, to build bone density. But some doctors are reporting cases of osteonecrosis of the jaw, or "dead jaw" syndrome, among patients taking the drugs.

Some of the symptoms of osteonecrosis are pain, swelling and gum infections, loosening teeth, poor healing of gums after dental work, numbness or heavy feeling in jaw.

It’s crucial to tell your dentist if you are taking bisphosphonates. Talk to your doctor about the benefits and risks of such drugs for you and your particular medical history and dental concerns. If you need major oral surgery in the future, do not start taking bisphosphonates until at least two months after the procedure or ask your dentist if nonsurgical endodontic treatments can be substituted for the surgery. It is very important to have regular dental checkups too.

More information can be obtained from The National Institute of Health Osteoporosis and Related Bone Diseases National Resource Center, The American Association of Endodontists and The American Dental Association.

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