This is an archived article that was published on sltrib.com in 2006, and information in the article may be outdated. It is provided only for personal research purposes and may not be reprinted.
Pamela Hines went from an active lifestyle of running five miles a day and working full-time to being unable to eat most foods and feeling constant pain.
The 52-year-old Sandy woman was diagnosed last year with osteonecrosis of the jaw (ONJ), a disfiguring condition that leads to the breakdown of the jawbone and loss of teeth. After having a tooth extracted, she became deeply concerned when her mouth failed to heal. After visiting several doctors, one told her she might have ONJ - and that it could be linked to her taking the popular osteoporosis drug Fosamax, for stronger bones.
Once she learned other dental patients who took Fosamax were suing the drug maker, Merck & Co., she joined a class-action lawsuit being handled by Tim O'Brien, a Pensacola, Fla., lawyer with the firm Levin Papantonio.
"The problem was known to Merck well prior to the present day," O'Brien said. "The [Food and Drug Administration] asked them to warn about ONJ. They needed to inform doctors and patients sooner."
For years, physicians and dentists have known about the increased risk of ONJ caused by chemotherapy. But the reason for the potential risk of ONJ for dental patients on bisphosphonates - the class of bone-strengthening drugs that includes Fosamax - is relatively unknown and has puzzled some experts.
In January 2005, the FDA recommended Merck change Fosamax's label to include ONJ warnings. The company revised its packaging information in July. The drug is one of Merck's best sellers, with $3.2 billion in sales and 22.4 million prescriptions written in 2005.
The company, still reeling from lawsuits on the recalled pain medication Vioxx, says on its Web site that most reported cases of bisphosphonate-associated osteonecrosis have been in cancer patients treated with the drugs intravenously.
"ONJ is not well understood and may occur for a number of reasons. . . . In controlled clinical trials involving more than 17,000 patients, contributing as much as 10 years' data with alendronate [the technical name for Fosamax] there have been no reports of ONJ," the statement says.
O'Brien filed his first Fosamax lawsuit in April in Fort Myers, Fla., on behalf of Linda Secrest, 60, who had been taking the drug for six years. She blames the drug for rotting her mouth and exposing her jawbone and alleges Merck withheld information about its health risks.
At its 2006 annual meeting, the American Association of Endodontists said that, until further information becomes available, all patients taking bisphosphonates be considered at some risk for ONJ, and should inform their dental care providers and other specialists they are on the medications.
Some dentists turn away patients who reveal they are on bisphosphonates, possibly because they fear lawsuits. Others ask those patients to quit the medication until their dental treatment is finished.
For Hines, the aftermath has been devastating. Now unemployed, she receives an intravenous antibiotic - ironically made by Merck - to help clear the infection in her mouth. She also undergoes hyperbaric treatment five days a week.
Patients who have hyperbaric treatment lie in an oxygen-rich, pressurized chamber that increases the blood and oxygen pumped to the wound, triggering the growth of new capillaries and accelerating healing.
Weighing a mere 85 pounds and appearing emaciated, Hines can only consume liquids and has lost 25 pounds. Once avid travelers and kayakers, she and her husband, Larry, have been mostly confined to their Sandy home so she can be close to her doctors.
Hines decided to take Fosamax after watching her grandmother suffer from osteoporosis, which severely weakened her spine.
"Your body is like a temple and you take care of it and then this happens," she said. "I want women to know if they have any problems with their mouth and they are on Fosamax, they should make the dentist aware of this. [ONJ] affects your life greatly. It turns your life upside down."
Others also want to raise awareness. After researching ONJ and being diagnosed with it, Beverly Hurwitz, a Salt Lake City doctor who treats chronic pain, sent out about 50 letters to dentists and oral surgeons in the state. She does not know whether her condition was caused by Fosamax because she only took a few doses. But because she only received a few responses to her letters, she is worried that dentists and the public are uninformed about the condition.
"I know there are millions of women who are on these drugs who need a root canal or other work," Hurwitz said. "There are probably thousands of people who have this and haven't been diagnosed. People say this is a rare condition, but it's only rare because it hasn't been identified" well.
Patrick Brain, an oral surgeon in Sandy, said more dentists and oral surgeons are becoming educated about the potential link between Fosamax and ONJ.
"It's a big problem, and it's becoming more pervasive," he said.
What is osteoporosis?
* Osteoporosis is thinning and weakening of the bones.
* It affects mostly women after menopause.
* In both men and women, osteoporosis may also be caused by certain medicines called corticosteroids, used in the treatment of some leukemias and also to suppress rejection after bone marrow and organ transplants.
* Osteoporosis can cause fractures, which may happen during everyday activities, such as lifting, or from a minor injury that would normally not cause bones to break.
Fosamax is for:
* The treatment or prevention of osteoporosis in women after menopause.
* Treatment to increase bone mass in men with osteoporosis.
* The treatment of osteoporosis in people taking corticosteroids.
To help prevent osteoporosis:
* Stop smoking.
* Reduce the use of alcohol.
* Exercise regularly.
* Eat a balanced diet with calcium.
* Ask your doctor if you need to take a calcium or vitamin D dietary supplement.