A US Food and Drug Administration advisory panel has said that there isn't enough information available for it to recommend limits for how long a patient should take a bisphosphonate drug to treat osteoporosis. The panel, however, did say that it was concerned about the number of women claiming to have developed thigh fractures and osteonecrosis of the jaw after taking Fosamax and similar medications over several years. Numerous Fosamax fracture lawsuits have even been filed. During its meeting on Friday, the panel voted in favor of adding more information on labels about the medications' effectiveness and safety when taken long-term--over three to five years.
Some four to five million people have prescriptions for a bisphosphonate drug filled each year. Actonel, Aclasta, Bonevia, Altevia, and Reclast are other biphosphonates. The Risk Management Advisory Committee and the Advisory Committee for Reproductive Health Drugs and the Drug Safety make up the FDA's advisory panel.
Fosamax, from Merck & Co, was approved in 1995 as the first approved bisphosphonate. At that time it was believed that Fosamax could be used indefinitely. Now, however, some researchers are wondering whether the benefits of taking the drug--the medication slows the bone breakdown that can come with aging--outweigh the possibility that it may also cause the bones to become so brittle that jaw death and/or thigh fractures can occur.
According to The Wall Street Journal, one California woman who testified before the FDA advisory panel said that her fracture occurred last May while she was throwing an item in the trash. She experienced a snap and then severe pain. Prior to her injury, Lanter, 68, would bike 25 miles each week and hike three miles a day. She had been taking Fosamax to treat her osteoporosis for nine years. There were other women that also testified before the FDA advisory panel about their fractures. X-rays of the injuries demonstrated the type of bone breaks that are usually associated with those sustained in car accidents.
The FDA is now reconsidering whether it will keep approving bisphosphonates for preventing osteoporosis. It, too, is looking at whether the suspected injury risks are worth the health benefits. It was just last year that, because of these concerns, the FDA recommended that doctors periodically reassess whether a patient should keep taking bisphosphonates.
Recently, questions have also been raised over whether Fosamax causes Esophageal ulcers and inflammation, which can lead to cancer.
Our Anaheim Fosamax fracture lawyers represent clients that have suffered thigh fractures, osteonecrosis of the jaw, severely suppressed bone turnover, and other serious side effects while taking this drug. We are experienced in holding drug manufacturers liable for Orange County, California personal injury.
FDA panel unclear on osteoporosis drug labels, CBS News, September 12, 2011
FDA Panel: Won't Make Treatment Recommendation For Osteoporosis Drugs, Wall Street Journal, September 9, 2011
More Blog Posts:
FDA Advisory Panel to Review Risks Associated with Taking Fosamax, California Injury Lawyers, September 8, 2011
Does Fosamax Increase the Risk of Esophageal Cancer?, California Injury Lawyers, July 31, 2011
Federal Fosamax Lawsuits Over Femur Fractures to be Coordinated Under Multidistrict Litigation, California Injury Lawyers, July 29, 2011