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Given to treat osteoporosis in patients, Fosamax, generically known as alendronate sodium, falls under the bisphosphonate drug category. The drug is designed to greatly reduce osteoporosis progression by halting the breakdown of old or damaged bones. Since the FDA approved the medication in 1995, an estimate 20 million people have used it.
Typically, doctors prescribe Fosamax to treat osteoporosis and pre-osteoporosis in post-menopausal women, men, anyone with steroid-related osteoporosis, and Paget’s disease of bone. When it’s given to patients at risk, it has been considered to prevent their condition from progressing further.
However, plaintiffs claiming manufacturer Merck was less-than-forth about the potentially life-altering side effects have since gone onto file thousands of lawsuits at state and federal levels. The largest group has been consolidated into multi-district litigation in New York.
Fosamax has been associated with several side effects, some potentially requiring patients to get corrective surgery:
- Irritation, inflammation, or ulceration of the esophagus
- Bone, joint, and muscle pain
- Atrial fibrillation, or abnormal heart rhythm
- Femur fractures
- Osteonecrosis of the Jaw (ONJ)
Out of these, ONJ has been the most common – but also the most devastating. Patients experience loosening teeth, gum lesions, osteomyelitis, or infection of the jaw bone marrow, and sequestration, or breaking of the jaw bone. Patients who went through dental surgery may have the greatest risk, but in all cases, the debilitating condition may require multiple surgeries to replace the broken jaw with other bone.
Studies have further found Fosamax usage may cause fractures in other parts of the body, including the femur – one of the skeleton’s strongest bones – as well as the knee and shoulder. Although a correlation between the drug usage and these conditions had been debated, an FDA study, followed by an advisory in 2011, revealed that long-term use may put patients at a greater risk. As a result, Fosamax and other osteoporosis drugs display labels stating the optimal period for usage is unknown.
With lawsuits occurring at state and federal levels, plaintiffs have gone after Merck, claiming the manufacturer understated the risks and overemphasized the benefits and failed to effectively warn about the side effects. In response, Merck has attempted to deflect blame onto the plaintiff, stating the side effects may be attributed to other conditions.
Bellweather trials now continue into 2014, while lawsuits specifically concerning femur fractures make up over 1,000 pending cases.
Along with not releasing all information to the public about Fosamax, lawsuits further allege Fosamax is unsafe, down to the design, label, and conditions in which it is manufactured, therefore making it dangerous for the public.
Although a settlement was reached in the multi-district New York case, plaintiffs at all levels have been seeking compensation for lost wages, medical expenses incurred from surgeries, pain and suffering, and other injuries.
A patient trusts in a doctor to provide medications that improve his or her condition, while medical professionals count on manufacturers to introduce safe drugs that have been fully studied and adequately tested. No one expects to take a drug to improve a harmful condition, only to find said medication exacerbated it. Beyond false marketing, manufacturers introducing defective drugs breach patients’ and medical professionals’ trust.