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 thousands of lawsuits over allegations that their osteoporosis drug Fosamax is the cause of jaw necrosis. Most of the cases are pending in the multi-district litigation (MDL) No. 1789 in the Southern District of New York. Judge Keenan is presiding over the MDL cases.
The first bellwhether trial ended in a mistrial. However, on retrial, the jury reached an $8 million verict for Mrs. Shirley Boles. The second bellwhether case was Maley v. Merck, and it concluded with a defense verdict. The third case is set for trial in the fall of 2010.
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.
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.
Low-Energy Femur Fractures Prompts Investigation and a New Safety Label Warning About Bone
The commonly prescribed osteoporosis drug, Fosamax, manufactured by the Pharmaceutical Company, Merck, has been linked to a rare type of femur fracture according to a study in the 2008 June Issue of the Journal of Orthopedic Trauma. The study found that twenty-five (25), out of seventy (70) patients who experienced low-energy femur fractures, took Fosamax for four years or more. Nineteen (19) of the twenty-five (25) Fosamax patients' fractures had distinct characteristics. It was a simple fracture with a straight line across the bone and a beak-like overhang on one side. The patients' bone appeared strong, unlike osteoporotic bone.
Fosamax is a bisphosphonate. It is prescribed to strengthen bones and prevent osteoporosis. A growing concern about its suspected link to low-energy femur (thigh bone) fractures prompted an investigative report by ABC World News Tonight on March 8, 2010.
The FDA has stated that it is investigating the suspected link between the use of Fosamax and an increase of low-energy femur shaft and subtrochanteric (thigh bone) fractures. In a statement, the FDA said it has not identified a link between the drug and the femur fractures, but it continues to study the issue with the assistance of experts from outside agencies including the American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force.
Recently, Merck updated its Adverse Reaction section of the Fosamax Label to include information about low-energy femoral shaft (thigh bone) fractures.
If you or a loved one have taken Fosamax and are experiencing unusual pain in the thigh or hip, you should contact your doctor. If you have been injured as a result of Fosamax side effects such as low-energy femur fractures, contact our Fosamax Attorneys for a free legal consultation.
What should I discuss with my healthcare provider if I am taking Fosamax?
Along with osteonecrosis of the jaw and low energy femur fractures, 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:
- Jury Awards Plaintiff $8 Million In Fosamax Lawsuit
A jury returned an $8 million compensatory damages verdict against Merck & Co. Inc. on June 25 in the U.S. District Court for the Southern District of New York in the retrial of the first Fosamax multidistrict litigation case to go to trial. - 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... - ABC World News reports: Breaking Bones
Can a drug meant to strengthen bones, such as Fosamax, actually cause a bone to weaken in some people after years of use? - Low-Energy Femoral Shaft Fractures Associated With Alendronate Use
Increasing evidence suggests long-term alendronate use may overly suppress bone metabolism, limiting repair of microdamage and creating risk for insufficiency fractures.
