Generic: Sodium alendronate
Manufacturer: Merck & Co.
Date approved: 2001
Status: Prescription only
Approved uses: Osteoporosis prevention and treatment
Off-Label uses: N/A
• Osteonecrosis (ONJ) of the jaw (“dead jaw syndrome”)
• Femur Fractures
• Esophageal Disorders
• Bone Pain and Swelling
Related topics: Unsafe drugs, Vioxx, bisphosphonates
Fosamax and Femur Fractures
Fosamax is a bisphosphonate manufactured by Merck and used to treat osteoporosis and decreased bone density in postmenopausal women. Many reports have linked Fosamax to sudden femur fractures, many of which occured during low-energy activities, such as walking down stairs. In addition, the drug has been shown to cause osteonecrosis (ONJ) of the jaw, or “dead jaw.” Osteonecrosis is a slow death of bone tissue that occurs because of poor blood supply to the bone. The deterioration is painful and often characterized by mouth swelling, loosening of teeth and exposed bone. Patients who have undergone chemotherapy, taken Fosamax intravenously, have a history of cancer, Paget’s disease or osteoporosis, use steroids while on Fosamax or have a history of major dental work are at an increased risk for ONJ. Other side effects include a risk of severe stomach ulcers when used in conjunction with Naproxin.
Fosamax Linked to Sudden Femur Fractures
Fosamax, a leading osteoporosis drug has been linked to a sudden and unexplained bone breaks in patients taking the medication.
Although the active ingredient is supposed to make bones stronger, some doctors believe it is responsible for many spontaneous fractures and breaks.
A news station in Charleston S.C. reported on a woman whose leg snapped while she was walking. X-rays showed a clean break through the middle of her thigh bone – an extremely rare type of fracture and coupled with the fact that she neither tripped nor fell prior to the break has made doctors curious.
Furthermore, it’s not a typical break for a person with osteoporosis.
Fosamax is designed to stop osteoclasts – cells that re-absorb bone in the body. Meanwhile, osteoblasts, the cells that make bone, are supposed to keep working, thus preventing osteoporosis. However, tests have revealed that both sets of cells have ceased function in patients who have suffered from these sudden fractures.
The rare fractures have been dubbed “frozen bone” by Dr. Robert Bunning, a lead rheumatologist at the National Rehabilitation Hospital. The brittle bone is more susceptible to fractures, with many patients only feeling vague thigh pain before the fracture.
Merck and Co Inc, the makers of the drug, and denied a link between the drug and the fractures. Osteoporosis has been blamed for many of the breaks, although doctors have been quick to point out that most osteoporosis breaks occur in the hip area and usually occur after a fall.
The U.S. Food and Drug Administration says it is aware of the allegations against the drug and are currently researching the situation. However, this is not the first harmful side effect linked to Fosamax.
The drug has been shown to cause a painful medical condition called osteonecrosis (ONJ), or �dead jaw.� Osteonecrosis is a slow death of bone tissue in the jaw that occurs because of poor blood supply to the bone. Side effects of ONJ include mouth swelling, loosening of teeth and exposed bone.
A New York federal judge refused to dismiss the lawsuits against Merck in early 2010 alleging the drug caused ONJ in an Indiana woman who took the medication for close to eight years. The lawsuit is one of almost 900 that have been filed nationwide.
In June 2010, a judge awarded an $8 million settlement to a women who claimed Fosamax was responsible for her osteonecrosis. This case is monumental because it may impact the way future lawsuits are decided against the company.
Merck plans to fight the verdict, calling it excessive and unnecessary.
Serious Side Effects Associated with Fosamax
For several years, Merck & Co., Inc. has produced alendronate sodium, a bisphosphonate which is marketed as the popular drug Fosamax or Fosamax D. Fosamax is used to treat osteoporosis and decreased bone density, and has been proven to help reverse bone loss in female patients. The drug is intended for use in conjunction with weight-bearing exercise, a healthy diet and vitamin use, and is taken in once-weekly doses in tablet or liquid (swallowed or intravenous) forms. Fosamax and Fosamax D are the most-prescribed osteoporosis drugs for post-menopausal women.
Fosamax side effects cited by Merck include heartburn, painful or difficult swallowing up to and including serious upper digestive problems, and severe joint and/or muscle pain. Merck suggests that women who suffer from low blood calcium, certain esophagus disorders, kidney disease refrain from taking Fosamax. In addition, Merck recommends that Fosamax patients do not lie down within 30 minutes of taking the drug in order to prevent irritation of the esophagus.
No Warnings For “Dead Jaw” In Fosamax Patients
What Merck does not warn against is the drug’s serious links to osteonecrosis (bone death) of the jaw (ONJ). Fosamax patients with osteonecrosis have insufficient blood supply to their bones, which prevents bone regeneration and contributes to the slow death of the bone. Often, dental work leads to traumas to the bone that do not heal, eventually fracture, and require long-term antibiotic care. While osteonecrosis can be managed, it is irreversible. More than 2,400 patients taking bisphosphonates have reported “dead jaw” since 2001.
Most of the dangerous side effects of Fosamax take place in chemotherapy patients who have the drug delivered intravenously; however, “dead jaw” has been noted in other patients as well. “Dead jaw” causes loosening teeth, swelling and severe infections. Other Fosamax patients suffer from debilitating joint and bone pain that results in being bed- or wheelchair-ridden or dependence on walkers and other assistive devices.
Risk for ONJ in Fosamax patients is based on four factors:
• intravenous use of Fosamax or Fosamax D;
• previous history of Paget’s disease, osteoporosis or cancer;
• history of dental procedures including implants or extractions;
• concurrent steroid use.
Other potential side effects of Fosamax include interactions with Naproxin (an arthritis drug) that can lead to severe stomach ulcers in some patients.
The Legal Battle Begins
In March, 2006, an FDA advisory committee announced that osteonecrosis lead to death in some patients taking bisphosphonates. This follows a battle to get osteonecrosis listed on Fosamax warning labels instead of embedded deep within a long brochure detailing the drug’s possible dangerous side effects. The FDA’s disclosure was quickly followed by a Fosamax lawsuit in which a female patient accused Merck of withholding warnings that the drug slowly kills jaw bone tissue. The complaint, which was filed in federal court in Fort Meyers, Florida, seeks to represent over 10 million Fosamax patients. In 2004, the Journal of Oral and Maxillofacial Surgeons published a study linking Fosamax to ONJ and bone death.
As the lawsuits slowly begin to accumulate, a class action lawsuit for Fosamax patients who have experienced adverse side effects after using the drug becomes more and more likely. Experts state that only ten percent of drug side effects are reported to the FDA; if you are a Fosamax patient experiencing “dead jaw” symptoms, the time may be right to file a complaint.