Fosamax and Bisphosphonate Timeline

Many researchers and doctors are calling the jaw problems associated with Fosamax and bisphosphonates "bis-phossy jaw." This didn't just come out of the blue. It turns out there's a long relationship between phosphorus and jaw necrosis.

Many researchers and doctors are calling the jaw problems associated with Fosamax and other bisphosphonates "bis-phossy jaw." This is derived from the 19th century term "phossy jaw." It turns out there's a long relationship between phosphorus and jaw necrosis. Note the "phos" in bisphosphonate. It's there because these drugs are phosphorus-based. Here's a short timeline of phosphorus, bisphosphonates, and osteonecrosis of the jaw. This timeline is a work in progress and additional information will be added.

phossy jaw 19th Century: Match factory workers come down with something called "phossy jaw." It is caused by exposure to white phosphorus. Their jaws abscess, causing pain and disfigurement. Foul-smelling pus drains from their jaws and their jaws glow in the dark (due to the phosphorus). The only treatment is removal of the jaw bone. If these steps are not taken, organ failure occurs and then death. The photograph to the left is of a man with phossy jaw.

Sept. 29, 1995: The FDA approves bisphosphonate drug Fosamax (alendronate sodium) for the treatment of post-menopausal osteoporosis and Paget's disease.

2001: Oral surgeon Salvatore Ruggiero notices that an unusual number of his patients have osteonecrosis of the jaw. He does some digging into their medical records and discovers they are all taking a bisphosphonate called Aredia. He phones Aredia's manufacturer, Novartis AG, and asks them if there are other cases of osteonecrosis related to the drug. He also submits reports to MedWatch.

2002: Not having heard back from the FDA after submitting his reports to MedWatch, Ruggiero calls MedWatch to ask whether they have received his information. "How many of these do I have to put on before something gets done?" he asks.

2003: The FDA takes notice as several reports of osteonecrosis from use of bisphosphonate drugs are submitted to their "postmarketing database."

Summer 2003: Oral surgeon Robert Marx, a department chief at the University of Miami's Miller School of Medicine, has 36 cases of osteonecrosis of the jaw that he suspects are linked to Aredia and Zometa. He calls Novartis to let them know he is planning to write a medical alert in the Journal of Oral and Maxillofacial Surgery warning of the problem.

Sept. 2003: Marx's article is published in the Journal of Oral and Maxillofacial Surgery.

Dec. 2003: By this time, Dr. Ruggiero has 54 patients with osteonecrosis of the jaw.

Aug. 25, 2004: The FDA reviews new cases of osteonecrosis associated with pamidronate and zoledronic acid that have been submitted to them. They also review cases of osteonecrosis associated with oral bisphosphonates. Their recommendation is that the labels be changed to warn patients about the risk of osteonecrosis of the jaw.

Sept. 2004: By this time, Novartis has received 500 case reports of jaw problems in patients taking Aredia and Zometa. The company decides to add a "precaution" to the labels of its bisphosponate drugs Aredia and Zometa and sends letters to doctors alerting them to the problem.

July 2005: Almost a year after the FDA recommended they do so, Merck adds a warning to Fosamax. The warning is buried several pages deep in the package insert.

2005: During 2005, 22.4 million prescriptions for Fosamax are given out.

April 2006: Linda Secrest files a class action lawsuit in Florida against Merck for not warning patients about the risk of osteonecrosis of the jaw in patients taking Fosamax. Hundreds of similar lawsuits are expected to be filed.

July 2006: Earnings reports for Merck are released. The company reports that Fosamax earned $821 million for the second quarter of 2006.

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