Rottenstein Law Group Notes With Approval Suggestion of FDA Advisory Panel That Fosamax Carry Label Warning Recommending Regular Re-Evaluations

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The Rottenstein Law Group, which represents clients with claims of harm resulting from use of the drug Fosamax, agrees with the recommendation of two FDA advisory panels that Fosamax and other bisphosphonates should carry label warnings advising those taking the drugs to speak with their prescribing physicians regularly to re-evaluate the risks and benefits of the medication.

Fosamax Femur Fracture

According to a Reuters article, two advisory panels of the U.S. Food and Drug Administration on Friday “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 Fosamax warning in October 2010, stating that the drug, among other bisphosphonates, causes atypical low-impact femur fractures Before that, in 2005, a warning of higher risk of osteonecrosis of the jaw had been added to labels, and in 2009, a caution about adverse gastrointestinal reactions.

The FDA, the Reuters piece 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 under review include 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 advisers 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, advisers said.” Accordingly, the FDA advisers voted 17-6 on Friday to make changes to bisphosphonate medication labeling, with many in favor of specifying how often patients need a re-evaluation of whether they need the medicine.

The Rottenstein Law Group urges anyone whose friend or relative has been prescribed Fosamax or another osteoporosis drug to reach out to that person and recommend that he or she consult a physician immediately and then speak to a qualified personal injury lawyer. The Rottenstein Law Group maintains a Fosamax Fracture Lawsuit Information Center at The site has features that allow for easy sharing, including links for automatic posting on Facebook and Twitter, specifically to enable visitors to spread the word about the dangers of Fosamax.

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, who has more than two decades of experience as a lawyer, to represent clients in consumer product injury, mass tort, and class action lawsuits in a compassionate manner.
The Rottenstein Law Group, LLP
Rochelle Rottenstein, Esq.
1259 Veeder Drive
Hewlett NY 11557
(212) 933-9500 (office phone)
(212) 933-9980 (facsimile)


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Rochelle Rottenstein, Esq.
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