Fosamax Resource Center
FOSAMAX® Bone Death of the Jaw
Fosamax, a medication used for bone loss, has been implicated in the serious necrosis of the jaw and other bones, a condition known as "osteonecrosis" (ONJ) – also called "bone death."
Recent studies suggest a link between the use of bisphosphonates, such as Fosamax or Aredia, and osteonecrosis. This condition is associated with the interference of the blood supply to the bone and the consequential damage that occurs. The majority of the reported cases are in cancer patients who have had, or are having, a dental procedure.
Fosamax can also irritate the esophagus, and care must be taken in order to avoid such irritation. Recently, researchers discovered that taking Fosamax in combination with the popular arthritis drug Naproxin may increase the risk of developing stomach ulcers.
The U.S. Food and Drug Administration asked Merck to add a warning to Fosamax's label in August of 2004 and it has yet to comply with that request. In a statement, Merck said that in all of its clinical trials of Fosamax, which have included more than 17,000 patients, it has not had any reports of osteonecrosis of the jaw. Merck said that there have been reports of patients taking Fosamax developing the condition but that doesn't necessarily mean the drug caused it.
Fosamax is taken by nearly 10 million men and women. Fosamax is Merck's second best-selling drug with last year's revenue at $3.2 billion.
If you or a family member have been taking Fosamax®, Actonel ®, Aredia®, or Zometa®, and have suffered any injuries or illnesses, please contact our Fosamax Attorneys for a free case evaluation.
Fosamax Frequently Asked Questions:
» What is Fosamax?
» Who manufacturers Fosamax?
» Are there any reported problems with Fosamax?
» What is osteonecrosis of the jaw?
» What are the symptoms of ONJ?
» How is ONJ diagnosed?
» What are the risk factors for developing osteonecrosis of the jaw?
» Who should not take Fosamax?
» What are the potential side effects of Fosamax?
» What should I do if I’m currently taking Fosamax?
What is Fosamax?
Fosamax (Alendronate Sodium Tablets) is a bisphosphonate medication used to increase bone mass, reduce bone fractures, and prevent and treat osteoporosis in post-menopausal women.
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Who manufacturers Fosamax?
Fosamax is manufactured by Merck & Company.
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Are there any reported problems with Fosamax?
Cases of osteonecrosis (involving the jaw) have been reported in patients treated with bisphosphonates. The majority of the reported cases are in cancer patients who are having, or have had, a dental procedure.
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What is osteonecrosis of the jaw?
Osteonecrosis of the jaw (ONJ)is a rare condition that involves the loss, or breakdown, of the jaw bone. ONJ has been reported in patients with cancer receiving treatment, including bisphosphonates, chemotherapy, and/or corticosteroids. The majority of reported cases have been associated with dental procedures such as tooth extraction. A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors. While on treatment, these patients should avoid, if possible, invasive dental procedures. No data are available as to whether discontinuation of bisphosphonate therapy reduces the risk of ONJ in patients requiring dental procedures.
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What are the symptoms of ONJ?
Tell both your oncologist and your dentist immediately if you experience any of these symptoms: pain, swelling, or infection of the gums; loosening of teeth; poor healing of the gums, and numbness or the feeling of heaviness in the jaw.
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How is ONJ diagnosed?
To diagnose osteonecrosis of the jaw, doctors may use x-rays or tests for infection (microbial cultures). Treatments for osteonecrosis of the jaw may include antibiotics, oral rinses, and removable mouth appliances. Minor dental work may be necessary to remove injured tissue and reduce sharp edges of the bone. Surgery is typically avoided because it may make the condition worse.
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What are the risk factors for developing osteonecrosis of the jaw?
Those at risk for developing ONJ include those individuals who have:
- Taken bisphosphonates, especially in IV form
- Been involved with concurrent use of steroids
- A previous history of cancer, osteoporosis or Paget's disease
- Had a traumatic dental procedure, such as tooth extraction or dental implants.
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Who should not take Fosamax?
Patients who should not take Fosamax include those who:
- Have certain disorders of the esophagus
- Are unable to stand or sit upright for at least 30 minutes
- Have low levels of calcium in their blood
- Have severe kidney disease
- Are pregnant or nursing
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What are the potential side effects of Fosamax?
Some patients may develop severe digestive reactions including irritation, inflammation or ulceration (occasionally with bleeding) of the esophagus. These reactions can cause chest pain, heartburn or difficulty or pain upon swallowing. This may occur especially if patients do not drink a full glass of water with Fosamax and/or if they lie down in less than 30 minutes or before their first food of the day. Esophageal reactions may worsen if patients continue to take Fosamax after developing symptoms suggesting irritation of the esophagus.
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What should I do if I’m currently taking Fosamax?
The most important step for patients currently taking Fosamax is to discuss their health and history with their physician. Your doctor is hopefully aware of the potential health risks associated with bisphosphonates and may advise using an alternative in order to minimize the risk of osteonecrosis from this drug. Patients must educate themselves on the potential risks, and, if they experience any side effects, must immediately contact their doctor.
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Fosamax® Links about Osteonecrosis from bisphosphonate medications for bone loss:
- Suit Alleges Merck Negligently Promoted Osteoporosis Drug Fosamax
Merck & Co., which is already facing a raft of cases over its pain reliever Vioxx, may need to hire additional attorneys to fight a recently filed lawsuit alleging the company was negligent in promoting its osteoporosis drug Fosamax.
- Wall Street Journal says industry moving slowly on dead jaw problems
After eight operations on patients whose jawbones turned out to be dead, oral surgeon Salvatore Ruggiero began doing some research in February 2001. He scoured the patients' medical records and discovered they had something in common: They were cancer patients taking a drug called Aredia to combat bone loss...
- Oral Surgeon Warns about "bis-phossy jaw"
Bisphosphonates, a class of drugs taken by millions of patients for osteoporosis and bone-related complications of metastatic cancer may actually contribute to the onset of osteochemonecrosis, or "bis-phossy jaw," a painful, potentially disfiguring jaw condition, according to an article published in the May issue of the Journal of Oral and Maxillofacial Surgery.
- Biphosphonates and Jaw Necrosis
Cancer patients given drugs called bisphosphonates to control hypercalcemia – too much calcium in the blood – or the growth of bone metastases can develop bone death in the jaw the FDA warns.
- Novartis Letter warns about its drugs causing osteonecrosis
Novartis is fully committed to assuring timely dissemination of safety information about their products to the healthcare community. We are writing to inform you of changes made to the Precautions and Post-Marketing Experience sections of the Aredia®.
- USA Today - Dead Jawbones linked to drug
Over a three-year period, the jaws of dozens of patients who had undergone oral surgery at his hospital had failed to heal properly. Part of the jawbone had died and become exposed.
Fosamax® additional links of interest:
- Drug linked to death of jawbone
Salvatore Ruggiero was puzzled. Over a three-year period, the jaws of dozens of patients who had undergone oral surgery at his hospital had failed to heal properly. Part of the jawbone had died and become exposed.
- Bone drugs' reverse danger
Rare instances of jaw decay are being linked to medicines, like Fosamax, used to prevent bone loss.
- Action On 'Jaw Rotting' Drug Erodes Merck's Share Price
SHARES in Merck, the American drugs giant, slipped 1.2 per cent in early trading on Wall Street yesterday amid reports that class action lawyers were targeting a second blockbuster drug at the company - Fosamax.
- Lawsuit Filed Against Fosamax Maker
"A class action lawsuit filed Monday charged that Fosamax, one of the most prescribed drugs to help increase bone density, actually does the reverse on the bone in the jaw, destroying it. The suit charges Fosamax chases osteonecrosis, or bone death, in the jawbone."
- Merck Sued Over Fosamax Health Risks
"Merck & Co., which faces more than 9,000 lawsuits over its Vioxx painkiller, misrepresented the safety of its osteoporosis drug Fosamax by withholding warnings that it could kill jawbone tissue, according to a lawsuit filed Monday. Linda Secrest, 59, sued Merck, accusing it of failing to warn doctors and patients that Fosamax could hamper blood flow to the jaw. Secrest, who began taking the drug in 2000, says she was diagnosed with jawbone tissue death in 2005. The condition is irreversible."
- Merck's Fosamax next legal battleground?
In the wake of the recent $15 million Vioxx verdict, plaintiffs' attorneys are already setting their sights on Merck's Fosamax. That according to a Wall Street Journal report Wednesday, which said that Merck's top-selling osteoporosis drug Fosamax is the second drug made by the embattled company to come into the crosshairs of the medical tort bar. A lawsuit was filed this week in Fort Myers, Fla., the report said, with the plaintiffs seeking class-action status."
If you or a family member have been taking Fosamax®, Actonel ®, Aredia®, or Zometa®, and have suffered any injuries or illnesses, please contact our Fosamax Lawyers for a free case evaluation.
