Actonel Warnings and Recalls

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Actonel (known generically as risedronate sodium) is a commonly prescribed medication used to treat and prevent osteoporosis in post-menopausal women. Actonel is manufactured and marketed by Proctor & Gamble and their partner Sanofi-Aventis. In March of 1998, the US Food and Drug Administration gave the drug approval for human consumption. Actonel is part of a class of drugs known as bisphosphonates which are used to slow the rate of bone loss.

It is estimated that close to 36 million women use medications such as Actonel to reduce their chances of developing osteoporosis or improve bone density if they have already contracted the illness. In the body, bone is contantly forming and dissolving. In osteoporosis, bone dissolves faster than it is formed, causing the bone to lose density. Actonel works by blocking the cells that cause bone dissolution. By effectively blocking these cells, Actonel allows the bone to gain density by forming faster than it dissolves. This causes the bone to gain strength and reduces the risk of stress fractures, which are painful and can be life threatening in certain cases.

A link between bisphosphonates, such as Actonel, and Osteonecrosis of the Jaw (ONJ) was discovered in 2004, six years after Actonel was released to the public. Osteonecrosis of the Jaw, also called Dead Jaw, is a condition in which the jaw bone does not heal after minor damage, such as with a tooth extraction. The bone remains exposed and can lead to infection, rotting, and eventual bone death. The earlier a case of ONJ can be diagnosed, the more treatment options the specialist will have. Cases that go undiagnosed and untreated can result in bone collapse leaving the sufferer disfigured.

Serious cases require the dying bone tissue to be removed through surgery, along with a long term antibiotic regiment. Experts estimate that over 2,400 individuals taking medications such as Actonel have suffered jaw bone decay and death due to ONJ, some suffering from such severe pain and debilitation that they have become bedridden. Removal of portions of the jaw can also result in an inability to chew solid food. The bone death is irreversible and the damage done by ONJ is irreparable.

After these findings were published in the Journal of Oral and Maxillofacial Surgeons, the US Food and Drug Administration (FDA) and the drug manufacturer, Proctor & Gamble, issued a warning to healthcare professionals and the general public about the increased risk of ONJ while on medications such as Actonel. While the warning indicated that clinical trials conducted before Actonel’s approval did not demonstrate an increased risk of ONJ, the FDA admits that sometimes the long-term effects of a drug do not manifest themselves until after the drug has been released to the general public. It is estimated that dozens of cases of osteonecrosis of the jaw will occur per year in patients taking Actonel and other bisphosphonates. Although it was determined that a warning to the healthcare community and general public was warranted, the risk was not determined to be severe enough to require a Actonel recall.

Do I have an Actonel 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 Actonel lawsuits. We are handling individual litigation nationwide and currently accepting new Actonel cases in all 50 states.

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