Rottenstein Law Group Acknowledges and Approves FDA Advisory Panel Suggestion That Fosamax Labeling Carry Patient Re-Evaluation Warning
(New York, NY, Spetember 12, 2011) The Rottenstein Law Group, which represents clients with claims of harm stemming from use of the drug Fosamax, agrees with the recommendation of two U.S. Food and Drug Administration (FDA) advisory panels that Fosamax, and other osteoporosis drugs should carry warning labeling advising those who are prescribed the drug to speak to their physicians regularly to re-evaluate the risks and benefits of taking the medication.
According to a Reuters article, two FDA advisory panels announced on Friday that they “declined to suggest how long women should take a class of drugs used by millions to prevent bone fractures, but agreed the labels should be changed to reflect uncertainty about the risks and benefits of long-term use.” The FDA had previously issued a warning about Fosamax and other bisphosphonate drugs in October 2010, stating that these drugs cause atypical low-impact thigh bone fractures. Prior to this latest warning, a warning about the potentially higher risk of osteonecrosis of the jaw was added, and in 2009, an advisory about adverse gastrointestinal difficulties.
The FDA, the Reuters article reports, “had asked two of its advisory panels to recommend whether a ‘drug holiday’ or some time limit was warranted on a class of osteoporosis drugs known as bisphosphonates that have been linked to unusual thigh fractures and other side effects.” (The drugs currently being reviewed are Merck & Co.’s Fosamax, Warner Chilcott’s Actonel, Roche’s Boniva, and Novartis’s Reclast. This class of drugs has also been linked to osteonecrosis of the jaw, or jaw bone death, and a possible higher cancer risk.) “Instead, the advisors voted 17-6 on Friday to make changes to the labeling with many in favor of specifying how often patients need a re-evaluation of whether they need the medicine,” Reuters reported.
“Studies presented by the FDA and the industry did not paint a conclusive picture to estimate whether benefits outweigh the risks in taking bisphosphonates for longer than three to five years or how exactly each of these drugs affects various subgroups of patients,” advisors said.
The Rottenstein Law Group advises anyone with a friend or family member who has been prescribed Fosamax or another osteoporosis drug to recommend to that person that he or she consult a physician immediately, then speak to a qualified Fosamax lawyer. The Rottenstein Law Group lawyers have a total of more than 25 years of experience fighting for the rights of clients who have suffered harm due to the negligence of powerful corporations. Affected individuals are advised to keep apprised of the latest news concerning the Fosamax femur fracture lawsuits by checking the Fosamax Femur Fracture Lawsuit Information Center for updated information. The site is equipped with easy-to-use social media features which will enable users to spread the word about the dangers of Fosamax.
About the Rottenstein Law Group
The Rottenstein Law Group is a New York-based law firm that represents clients in mass tort actions. The firm was founded by Rochelle Rottenstein, a lawyer with over two decades of experience in compassionate representation of clients in consumer product injury, mass tort, and class action law suits. For more information, please visit their Web site, or call (888) 9-ROT-LAW.
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