Fosamax Warnings and Recalls

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Fosamax (known generically as alendronate sodium) is a prescription medication used to treat and prevent osteoporosis in men and women. Fosamax is manufactured and marketed by Merck and Company Inc. In September of 1995, the US Food and Drug Administration (FDA) gave the drug approval for human consumption. Fosamax belongs to a class of drugs known as bisphosphonates, used to reduce the rate of bone loss.

Experts estimate that 36 million women use drugs such as Fosamax to reduce the chance of developing osteoporosis or improve bone density. Bone is contantly forming and dissolving in the body. During osteoporosis, bone dissolves at a higher rate than it is formed, resulting in the bone losing density. The active ingredient in Fosamax blocks the cells that cause bone dissolution. By blocking these cells, Fosamax allows the bone to increase density by forming at a greater rate than it dissolves. This causes the bone to increase strength and reduce the risk of fractures, which are painful and can be life threatening in certain cases.

The connection between bisphosphonates, such as Fosamax, and Osteonecrosis of the Jaw (ONJ) was discovered in 2004, almost ten years after Fosamax was released to the public. Osteonecrosis of the Jaw, also called Dead Jaw, is an affliction in which the jaw bone does not repair itself after minor damage, such as with a tooth extraction. The bone remains exposed, leading to infection, rotting, and even bone death. The earlier a diagnosis can be made, the more treatment options a medical specialist will have. Cases that go untreated or undiagnosed can result in the bone collapsing, leaving the sufferer disfigured.

Serious cases require the dead bone tissue removed through surgery, coupled with a long-term antibiotic regiment. Experts estimate that more than 2,000 individuals taking medications such as Fosamax have contracted ONJ resulting in jaw bone decay and death. Some patients suffer such severe pain and debilitation that they become bedridden. The removal of portions of jaw bone has also resulted in an inability to chew solid food. Bone death is permanent and the damage done is irreparable.

Following these findings being published in the Journal of Oral and Maxillofacial Surgeons, the FDA and drug manufacturer, Merck, issued a warning to medical professionals and the general public about the increased risk of ONJ while taking medications such as Fosamax. Clinical trials conducted before Fosamax’s approval did not reveal an increased risk of ONJ, but occasionally the longer-term effects of a medication do not appear until after the drug has been released for use. It is estimated that dozens of ONJ cases will be diagnosed annually in patients taking Fosamax and other bisphosphonates.

Although a warning to the medical community and general public was warranted, the risk was not shown to be severe enough to require a recall of the medication. Even so, many in the medical community are recommending that patients should reevaluate their decision to take Fosamax based on the new information. The risks and benefits of taking Fosamax should be discussed between medical professionals and their patients, allowing for an informed decision of whether the medication is right for the person involved.

Do I have a Fosamax Side Effects Lawsuit?

The Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in Fosamax lawsuits. We are handling individual litigation nationwide and currently accepting new Fosamax side effect cases in all 50 states.

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