Zometa

zoledronic acid

Zometa, known generically as zoledronate, is a bisphospate drug used to prevent skeletal fractures, particularly in patients with cancers such as multiple myeloma and prostate cancer. It can also be used to treat hypercalcemia of malignancy and pain from bone metastases.

Dr. Gregory Lutcavage, an oral and facial reconstructive surgeon in Goldsboro, North Carolina, sees a connection between drugs containing bisphosphonates and osteonecrosis of the jaw (ONJ). ONJ is a devastating condition in which the soft tissue inside a person’s jaw dies.

Symptoms include:

• jutting and exposed bone
• spontaneous jaw fractures
• raw and seeping infections
• facial collapse and disfigurement

The condition was once known as “fossy jaw” or “phossy jaw” because it developed in workers who were exposed to phosphorus in match-making plants.

Bisphosphonates include Fosamax as well as the intravenous drugs Aredia and Zometa, used in the treatment of cancer. Dr. Lutcavage said, historically, patients on bisphosphonates may not show the effects of exposure until they have been using the medicine for some time. On average patients using the intravenous medications Aredia and Zometa see symptoms of ONJ within one year, if at all, but most patients on Fosamax take the drug for as long as three years before they see negative side effects.

In Dr. Lutcavage’s practice, he has seen 24 cases of fractures and ONJ related to bisphosphonate drugs.

On October 1, 2007, the United States Food and Drug Administration (FDA) released its conclusion from a review of bisphosphonate drugs, including Zometa. Despite a New England Journal of Medicine article published in May 2007 that raised safety concerns about the drugs, the FDA said doctors and patients should continue using them.

Fosamax may cause debilitating jaw disease

Florida woman files Fosamax class action lawsuit

In April 2006, Linda Secrest filed a Fosamax lawsuit against Merck & Co. in federal court in Fort Myers, Florida. Secrest accused Merck of failing to warn doctors and patients that Fosamax , the most-prescribed osteoporosis treatment in the U.S. for post-menopausal women, could hamper blood flow to the jaw, potentially causing irreversible damage to the face and mouth. Now, more people are supporting her Merck lawsuit.
Secrest’s suit seeks to represent more than 10 million Fosamax users and was the second of as many as 200 possible lawsuits that may be filed in Florida on behalf of Fosamax users. Secrest is seeking a change in the prescribing information given by Merck to doctors who recommend Fosamax to their patients and wants Merck to pay for the cost of monitoring her jawbone necrosis. Source: “Merck Sued Over Fosamax Health Risks,” Bloomberg.com, April 11, 2006.

Osteonecrosis of the jaw (ONJ) linked to Bisphosponate Drugs

Catherine Van Poznak, M.D., assistant professor of internal medicine at the University of Michigan Medical School, has published an article linking a disfiguring and debilitating condition to the class of drugs known as bisphosphonates. The article, which appeared in the October 2006 issue of Current Opinions in Orthopaedics, summarizes the currently available data on osteonecrosis of the jaw (ONJ), a condition marked by exposed and deteriorating jawbone that cannot be reversed.

According to the study, as many as ten percent of cancer patients taking bisphosphonates have developed osteonecrosis of the jaw.

Sources: “Drug used for advanced cancer could cause exposed bone in jaw,” Brightsurf.com Science News, October 3, 2006; Catherine Van Poznak and Brent B. Ward, “Osteonecrosis of the jaw (abstract),” Current Opinion in Orthopedics 17:5 (October 2006), accessed October 4, 2006.

MORE JOIN FOSAMAX CLASS ACTION LAWSUIT

Utah woman joins Fosamax class action lawsuit

Pamela Hines of Utah was diagnosed with osteonecrosis of the jaw (ONJ) after a routine tooth extraction. ONJ, also known as jawbone necrosis, is a disfiguring and irreversible breakdown of the jawbone and loss of teeth. Hines’s mouth failed to heal after her extraction. She visited several doctors before learning her ONJ could be linked to the Fosamax she had taken to prevent the loss of bone she now experiences. Hines’ weight dropped to only 85 pounds. She is forced to receive an intravenous antibiotic to help clear her mouth infection. At the time she joined the lawsuit, she was unemployed and undergoing a hyperbaric treatment five days a week. The treatment requires her to lie in an oxygen-rich, pressurized chamber in order to increase the blood and oxygen pumped to her wounds. Despite the fact that osteonecrosis of the jaw “can’t be fixed,” according to Hillel Ephros, chair of the St. Joseph’s Regional Medical Center in Paterson, NJ, Merck has never released a “Dear Doctor” letter warning of the ONJ risk associated with Fosamax.

Carey Hamilton, “Fosamax lawsuit brings risks to light,” Salt Lake Tribune, June 20, 2006, accessed June 22, 2006; Ed Silverman, “Bone-building drugs linked to bone-rotting side effect,” New Jersey Star-Ledger, June 13, 2006, accessed June 22, 2006.

FDA Warned Merck of the dangers of Fosamax

Tissue death from ONJ is irreversible

In July of 2005, the FDA told Merck to add a warning notice to the labeling for Fosamax warning of the risk of jawbone necrosis. Merck claims the risk of jawbone necrosis to patients on Fosamax is rare. Once the jawbone is affected with osteonecrosis, there is no way to halt the process of tissue death. Symptoms include: jutting and exposed bone, spontaneous jaw fractures, raw and seeping infections, facial collapse, and disfigurement. Should the FDA have ordered a Fosamax recall in 2005? What can the Fosamax lawyers in America do to help people afflicted with this disease because of the drug?

Sources: “The Current Facts about Osteonecrosis of the Jaw and Osteoporosis Drugs,” Foundation for Osteoporosis Research and Education (FORE), 2006, retrieved August 24, 2007; Ashraf Badros, et.al., “Osteonecrosis of the Jaw in Multiple Myeloma Patients: Clinical Features and Risk Factors,” Journal of Clinal Oncology 24:6, February 20, 2006.

Do You Need A Fosamax Lawyer? – Free Call, No Obligation

If you or someone you love have been taking Fosamax to control to prevent osteoporosis or to treat Paget’s disease and have experienced loose teeth or pain, swelling, bleeding, or exposed bone in the jaw or gum, healthcare professionals suggest you see a physician immediately. Contact our personal injury law firm today. A consultation with a product liability lawyer may be in your best interest. If Merck knew the risks of taking Fosamax were more dangerous than it claimed, you may be entitled to compensation for the injuries you may have suffered as a result.

Our lawyers are investigating the circumstances of this case. Your information will be reviewed by a Fosamax lawyer who may be able to help you gain compensation from a Fosamax lawsuit.

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