Practice Area: Fosamax
Fosamax® (alendronate), a prescription drug manufactured by Merck, is used to treat osteoporosis, a disease in which bones become increasingly fragile. Drugs like Fosamax, called bisphosphonates, are prescribed to increase bone density, but recent evidence indicates it may have the opposite effect and destroy bone. A 2004 FDA analysis linked bisphosphonates to osteonecrosis of the jaw (ONJ). ONJ is an irreversible condition in which the jawbone dies and is unable to regenerate,
Fosamax is the most commonly dispensed bisphosphonate in the United States: 22 million prescriptions were written in 2004. Bisphosphonates, once taken, remain in the bones indefinitely.
Symptoms of ONJ include the following:
- Loose teeth
- Jaw pain
- Exposed bone
- Severe mouth infections
- Swelling in the mouth
- Mouth ulcers and sores
Fosamax Lawsuit Progress
The drug manufacturer Merck & Co. is currently facing 900 lawsuits over allegations that their osteoporosis drug Fosamax is the cause of jaw necrosis. The trial began on August 11 in a case that could strongly affect all of the others.
The trial, which was filed by Shirley Boles, 71, will take place in New York. The case is one of three bellwether cases that could lead to out-of-court settlements being made.
As of June 30, Merck is facing close to 900 Fosamax lawsuits filed by what may be as many as 2,000 plaintiffs.
The plaintiffs in the Fosamax lawsuits are alleging that Merck failed to warn both patients and doctors that the drug may inhibit blood flow to the jaw area, which in turn lead to jawbone-tissue necrosis, commonly referred to as osteonecrosis of the jaw, or ONJ.
The plaintiffs are further alleging that Merck misrepresented the drug's safety when it refused to use the language requested by the FDA when it changed its label in 2005.
Merck is currently disputing the claims, and says that there is no direct evidence that Fosamax causes osteonecrosis.
How Much Did Merck Know?
"Merck had notice through adverse reports starting in 1996", Boles attorney recently stated in an interview. Since then, the company has had "thousands of reports" regarding jawbone-tissue loss, he elaborated.
A major issue that is being raised in the Fosamax lawsuit is over whether Fosamax can cause ONJ if it's taken for a period of less than three years. The judge presiding over the case has put off a decision regarding what expert testimony he will allow on the subject for now; the issue isn't relevant to the Boles' case since she took the drug for longer than three years.
The federal-court Fosamax trials are currently slated for December and January. An additional state court trial is scheduled later this year in Alabama.
If you or a loved one have been injured by Fosamax and are experiencing complications, contact us for a free consultation and case evaluation by our drug recall attorneys.
Fosamax - What is it?
Fosamax belongs to a group of medicines known as bisphosphonates (bis-FOS-fo-nayts). This class of drugs changes the cycle of bone formation and breakdown in the body. Fosamax was created to slow bone loss while increasing bone mass, which may help to prevent bone fractures.
Fosamax is most commonly used to treat or prevent steroid-induced osteoporosis and postmenopausal osteoporosis. It has also been used to treat Pagets disease of the bone.
Important facts regarding Fosamax - Fosamax Problems
Many individuals taking bisphosphonates like Fosamax have developed problems, including bone loss in the jaw, also known as osteonecrosis of the jaw. The symptoms of jaw osteonecrosis often include numbness, loose teeth, jaw pain, swelling, slow healing after injury or surgery involving the gums and gum infection. Most people taking Fosamax are more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.
What should I discuss with my healthcare provider if I am taking Fosamax?
Along with osteonecrosis of the jaw, Fosamax can cause serious problems in the stomach or esophagus.
If you have cancer or have been treated with chemotherapy, radiation, or steroids you may be more likely to develop osteonecrosis of the jaw. Conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and dental surgery.
Fosamax is FDA pregnancy category C. which means this medication may be harmful to an unborn baby. You should tell your doctor if you are pregnant and have taken Fosamax. It is not known whether Fosamax passes into breast milk or if it could harm a nursing baby.
Fosamax Related Links:
- 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. - Side Effect Watch: Femur Fractures in Fosamax Patients
A study in the current issue of the Journal of Orthopedic Trauma links Merck's osteoporosis drug Fosamax to a rare type of fracture in the femur. - 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. - 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. - 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 problems with Fosamax
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...
