Fosamax Timeline
19th Century—Match factory workers, who are constantly exposed to white phosphorus, come down with condition in which their jaws abscess, causing pain and disfigurement. If jawbone is not removed, organ failure occurs, followed by death.
September 29, 1995—The Food and Drug Administration approves the bisphosphonate drug Fosamax (alendronate sodium) for the treatment of post-menopausal osteoporosis and Paget’s disease. Its maker is Merck.
2001—Long Island oral surgeon Salvatore Ruggiero finds that an unusual number of his patients have osteonecrosis of the jaw, and all of them have taken a bisphosphonate—whether Fosamax, Actonel, Zometa, Boniva or Aredia.
2003—The FDA notes submission of several reports of osteonecrosis of the jaw resulting from use of bisphosphonate drugs.
Summer 2003—Oral surgeon Robert Marx of the University of Miami medical school has 36 cases of jaw necrosis, which he suspects are linked to the use of bisphosphonates.
September 2003—The Journal of Oral and Maxillofacial Surgery publishes a medical alert by Dr. Marx about drugs linked to osteonecrosis of the jaw.
December 2003—By this time, Dr. Ruggiero has more than 50 patients with jaw necrosis.
August 25, 2004—The FDA reviews new cases of osteonecrosis and recommends that label of Fosamax and other bisphosphonates be changed to warn patients about the risk of osteonecrosis of the jaw.
September 2004—By this time, Novartis has received 500 case reports of osteonecrosis of the jaw in patients taking Aredia and Zometa. The company decides to add a “precaution” to the labels of its bisphosponate drugs and sends letters to doctors informing them of the problem.
July 2005—Almost a year after FDA recommended it do so, Merck responds to Fosamax problems and adds a warning to Fosamax label.
2005—More than 22 million prescriptions for Fosamax are written despite side effects.
April 2006—The first class action lawsuit is filed against Merck for not warning patients taking Fosamax about the risk of osteonecrosis of the jaw. Hundreds of similar Fosamax lawsuits are expected to be filed.
June 2, 2006—The New York Times publishes article about connection between Fosamax and osteonecrosis of the jaw.
July 2006—In spite of ongoing news about Fosamax and jaw problems, Fosamax sales in second quarter of 2006 reach $821 million.
December 2006—Critics protest Merck’s deep involvement in design of Fosamax study, results of which are published in Journal of American Medical Association. It says that women who take Fosamax for 5 years are no more likely to suffer bone fractures than those taking it for 10.