Fosamax lawsuits have been on the rise recently because of increased attention paid to the link between Fosamax and osteonecrosis of the jaw (ONJ). Fosamax is the brand name for alendronate, a drug manufactured and marketed by Merck & Co. for the treatment of certain bone conditions including osteoporosis and osteitis deformans (Paget's disease). Although Fosamax has proven to be a successful oral treatment for such bone conditions, it has also been the cause of a number of serious side effects, notably the development of osteonecrosis of the jaw.
As of 2006, there were approximately 15 Fosamax lawsuits pending against Merck for its role in producing a drug capable of eliciting such serious side effects as ONJ. Instances of Fosamax-induced osteonecrosis of the jaw have been limited to a few known cases, though it is expected that countless other users are afflicted without yet being aware. In fact, it has been estimated that more than 1,000 cases of osteonecrosis of the jaw have been reportedly caused by Fosamax use, though many of these patients may have been treated for cancer and therefore received much higher doses of the oral bisphosphonate. Nonetheless, there remains a great deal of concern regarding Fosamax's propensity towards causing the development of ONJ. Some legal experts forecast a sharp increase in the number of Fosamax lawsuits filed by ONJ victims.
Aside from its notorious arthritis drug Vioxx, Fosamax has been Merck's best selling product, accounting for more than $3 billion in revenue for 2005. The pharmaceutical giant has been accused of having had information regarding the link between Fosamax and osteonecrosis of the jaw prior to widespread knowledge of the serious side effect. It has been suggested that Merck opted to withhold this information in order to protect profitability of its second most popular drug, especially given the turmoil it was facing with regards to Vioxx. This alleged misconduct has been the basis for a number of Fosamax lawsuits.
Drug manufacturers have a responsibility to ensure the safety and efficacy of their products prior to marketing them to the general public. The Food and Drug Administration (FDA) monitors the development of new drugs and requires extensive clinical trial testing before it will consider their approval. The fourth and final phase of a given clinical trial coincides with FDA approval and involves long term study and evaluation of a drug's potential to eventually elicit side effects.
FDA approval of a drug does not rule out manufacturer liability should users be affected by serious side effects. As such, Merck & Co. find themselves at the center of a great deal of litigation with regards to the development of Fosamax side effects, even though the drug is FDA approved and has not been recalled. Patients suffering from bisphosphonate associated osteonecrosis of the jaw (BON) resulting from Fosamax use may find that they have legal recourse against Merck & Co.
The recent surge in Fosamax lawsuits is directly related to the causative relationship held between Fosamax and ONJ. Fosamax side effects can include a number of mild to moderate GI tract abnormalities, vision problems, or the development of serious conditions like Stevens Johnson Syndrome (SJS) or ONJ. Fosamax users displaying signs of ONJ are advised to immediately consult with their physician as to the appropriate course of action. The first step in treating BON is halting use of the bisphosphonate drug assumed responsible for presentation of the serious bone condition. If a case of BON is not dealt with in a timely manner, it could culminate in jawbone death and joint collapse, requiring the sufferer undergo major reconstructive surgery.
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