Recently, the FDA’s Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee held a joint meeting to discuss the appropriate duration of use for Fosamax and other bisphosphonates. Among other things, the committees discussed the risks and benefits of these drugs. As you may recall from our previous articles on bisphosphonates, these are drugs prescribed for the treatment of bone loss and osteoporosis.
Earlier this year the FDA required manufacturers of bisphosphonates to include language in their labels stating that the optimal duration for patient use has not yet been determined and that patients should consult with their physicians on a regular basis to re-evaluate their use of these medications. The FDA, as reports of atypical fractures continue to emerge in long-time bisphosphonate patients, has had to take a stronger position. It has become a sensitive topic for the FDA.
This is another instance where the FDA has weighed in on bisphosphonates. You may recall last year, that the FDA required language regarding an increased risk of atypical femur fractures after an American Society for Bone and Mineral Research task force concluded that the risk does, in fact, exist.
There have also been recent developments in New Jersey where the Judicial Panel for Multi District Litigation has consolidated all federal cases under In re: Fosamax Products Liability Litigation (No. II), MDL 2243. This litigation encompasses hundreds of cases against Merck Sharp & Dohme, Corp. involving femur fractures. The cases are consolidated under U.S. District Judge Garrett E. Brown, Jr. in the District of New Jersey.
Chad Cook, a lawyer in our firm’s Mass Torts Section, has been selected to help direct this litigation. He is one of 11 lawyers appointed by Judge Brown to the Plaintiffs Steering Committee (PSC), which will oversee the consolidated litigation. Our firm continues to investigate new claims involving individuals who took Fosamax and suffered a femur fracture. If you need more information on Fosamax, contact Chad Cook at 800-898-2034 or by email at Chad.Cook@beasleyallen.com.
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