FOSAMAX AND DENTAL PROCEDURES

Jaw Complications May Be Linked to Bone-Saving Drugs
www.RedNova.com
Jun 22, 2005 

Three months after Betty Beckman had a broken tooth pulled, her jaw still hasn't healed. So the Nebraska City woman travels each weekday to Omaha, where doctors put her in a pressure chamber in which she breathes pure oxygen, in hopes of helping her jaw heal.

What left her with a sharp, exposed piece of jawbone isn't clear. But after a friend gave her an article about puzzling cases in which patients had patches of jawbone die after similar procedures, Beckman suspects that it may have something to do with a drug she's taking. And she wants to warn others who might be at risk.

The patients in the article, like Beckman, took drugs called bisphosphonates. Most, like Beckman, were cancer patients receiving high intravenous doses to lower elevated blood calcium or prevent cancer from invading bone. A few were osteoporosis patients taking oral versions marketed under names like Fosamax and Actonel to strengthen bone.

"After I read it, I thought, 'Oh, dear,'" said Beckman, 65.

Although some doctors are beginning to share Beckman's suspicions, it's unclear whether the normally bone-saving drugs play a role in jawbone death. Some don't think there's a connection to osteoporosis drugs. The anecdotal cases and the roughly 875 reports that the IV drugs' maker had received by February from among millions of users point to a small risk among users.

The concern arises because use of the drugs, particularly for osteoporosis, is growing. Doctors don't know as much as they would like about the jaw condition and have few tools to treat it. The best way to prevent it, at least among cancer patients, may be to do a dental exam and repair any problems before treatment begins with the drugs.

"It's more of a public awareness and medical awareness issue," said Dr. Michael Miloro, chief of oral and maxillofacial surgery at the Nebraska Medical Center, who is treating Beckman.

Oral surgeons were among the first to notice the problem. In May 2004, a New York doctor reported seeing 63 patients with the jaw condition from February 2001 to November 2003.

Of those cases, 56 had received the IV drugs Zometa or Aredia; seven had been taking oral medications.

After a tooth is pulled, the bone typically remolds itself and fills in the gap. But the drugs inhibit cells that take away dead bone and clear the way for other cells to finish the rebuilding job.

An estimated 90 percent to 95 percent of the 875 cases have been in cancer patients taking the intravenous versions, said Dr. John Hellstein, clinical professor of oral and maxillofacial pathology at the University of Iowa.

A smaller number have shown up in osteoporosis patients, he said. He based his estimates on published reports, the cases he has seen and those he has discussed with other doctors.

But Dr. Robert Recker, director of Creighton University's Osteoporosis Research Center, said he isn't convinced that there's a risk associated with the osteoporosis drugs.

Recker has treated several thousand patients with oral bisphosphonates in clinical trials and in practice. He also has seen clinical trial data on the drugs as a member of scientific advisory boards for Merck and Procter & Gamble Pharmaceuticals, the respective makers of Fosamax and Actonel.

"I don't think there's any significant risk in patients who have osteoporosis," he said. "The risk is in patients who are taking giant doses for cancer."

No one is advising patients to stop taking the drugs, which produce clear benefits, Hellstein said. "You don't want to scare people not to take their osteoporosis medicine, because that would be a lot worse."

Novartis, which makes the intravenous drugs, has added inserts to package labels noting that it has received reports of the condition among patients taking the drug. The company sent a letter to dentists in May and has produced a brochure for cancer patients.

Merck, maker of Fosamax, is in discussions with the Food and Drug Administration about the matter. Procter & Gamble Pharmaceuticals plans to add precautions about the condition to Actonel's labels at the FDA's request.

Miloro said it's unclear whether the pressure chamber treatments will work for Beckman.

"I can't blame anyone," she said. "I just wish I'd known."

If you suffer from jaw osteonecrosis (ONJ) or death of the jaw as a result of taking Fosamax you should contact an attorney. Please fill out the form below and your submission will be forwarded to an experienced attorney.