Fosamax
Fosamax is a bisphosphonate medication used for bone loss. How, similar bisphosphonates have been implicated in the serious necrosis of the jaw and other bones, a condition known as "osteonecrosis."
In the U.S. Package Insert for both Aredia and Zometa, the following information on osteonecrosis had previously been added to the Adverse Reactions section under Post-Marketing Experience.
"Cases of osteonecrosis (primarily involving the jaws) have been reported in patients treated with bisphosphonates. The majority of the reported cases are in cancer patients attendant to a dental procedure. Osteonecrosis of the jaw has multiple well documented risk factors including a diagnosis of cancer, concomitant therapies (e.g., chemotherapy, radiotherapy, corticosteroids) and co-morbid conditions (e.g., anemia, coagulopathies, infection, pre-existing oral disease). Although causality cannot be determined, it is prudent to avoid dental surgery as recovery may be prolonged."
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.
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.
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...
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.
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.
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.
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."
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