If you were not told of the FDA's Fosamax® warnings or if you took the drug before the dangers were known and have been injured as a result, contact the attorneys at Phillips and Associates for a free case evaluation.
Fosamax® Timeline: Path from FDA Approval of Fosamax® to Warnings and Current Lawsuits
The attorneys at Phoenix-based Phillips and Associates know that you may not be aware of the extensive history of Fosamax®. You may be considering a lawsuit, but you are not sure if it is warranted. The timeline below will take you through the FDA approval of Fosamax®, the subsequent warnings, eventual label changes, and current and pending lawsuits. View the drug's history for yourself.
1997: Missing Fosamax® Warnings
2000: FDA Fosamax® Approval Expanded to Men
2004: Bisphosphonates and ONJ Connection and Warnings
2005: New Fosamax® Product, Warning Label Update, and Banner Year
2006: Fosamax® Lawsuit and Merck's Response
1995
September 29, 1995: FDA Approves Fosamax®
Merck and Company, Inc. (Merck) received approval from the U.S. Food and Drug Administration ( FDA) to market Fosamax® for the treatment of osteoporosis, primarily in postmenopausal women, and for the treatment of Paget's disease.
1997
April 14, 1997: FDA Letter Regarding Fosamax® Discusses Missing Warnings
The Division of Drug Marketing, Advertising and Communications (DDMAC) of the FDA sent a letter to Merck stating that marketing material for Fosamax® failed to list warnings for the drug. The letter stated the material lacked "fair balance" because the benefits of Fosamax® were outlined, but the warnings and risks were not.
1999
July 16, 1999: Merck Admonished by FDA for Misleading Fosamax® Advertising
Through another DDMAC letter, the FDA stated that advertisements for Fosamax® and Vioxx® violated the Federal Food, Drug, and Cosmetic Act. One advertisement failed to mention Fosamax® by name, did not post any warnings for the drug, and did not indicate the drug's approved indication and usage.
2000
September 2000: FDA Expands Fosamax® Approval to Include Men
The FDA expanded its Fosamax® approval to include the treatment of osteoporosis in men.
2001
2001: Oral Surgeons and Dentists Notice Link between Bisphosphonates and ONJ
In 2001 dentists and oral surgeons began to note the correlation between jaw decay (the onset of ONJ) and bisphosphonates use. It was initially believed that this link only related to cancer patients taking the intravenous form of bisphosphonates, but it later became evident that Fosamax® and other oral forms of the drugs could also cause ONJ.
June 20, 2001: FDA Charges Merck with Minimizing Fosamax® Warnings on Website
The FDA issued another Fosamax® warning letter stating that Merck once again violated the Federal Food, Drug, and Cosmetic Act. The FDA outlined that the drug's website "overstates the benefits of Fosamax® while minimizing the risks." It further listed the fact that Merck tried to minimize the serious side effects of Fosamax® by placing warnings under the title of "Proven Tolerability."
2004
May 2004: Journal of Oral and Maxillofacial Surgery Article Supports Bisphosphonates and ONJ Connection
Salvatore Ruggiero, DMD, MD, the chief of the Division of Oral and Maxillofacial Surgery at Long Island Jewish Medical Center and his staff collaborated with doctors in the Oral-Maxillofacial Surgery Division at the University of Maryland Medical Center to write an article in the Journal of Oral and Maxillofacial Surgery. The article outlined a study of 63 patients who were diagnosed with ONJ. The majority of the patients were cancer patients who received the stronger, intravenous form of bisphosphonates, but the remaining 11 percent of ONJ patients were taking an oral form of the drug, like Fosamax®, for osteoporosis.
August 2004: Novartis Changes the Labeling for its IV Bisphosphonates
Spurred by the findings detailed in the Journal of Oral and Maxillofacial Surgery article, Novartis changed the labeling for the two intravenous bisphosphonates that it manufactured, Aredia® and Zometa®, to list the warnings regarding the correlation between using bisphosphonates and the onset of ONJ.
September 24, 2004: FDA Issues Fosamax® Warning to Health Care Professionals
Also prompted by the article in the journal, the FDA released a Fosamax® warning to health care professionals. The letter outlined the findings relating the link between jaw decay and the use of Fosamax® and other bisphosphonates.
2005
April 12: 2005: FDA Approves Fosamax® Plus D
Merck received FDA approval to market Fosamax® Plus D. The new version of Fosamax® has an added dose of vitamin D.
July 2005: Merck Updates Fosamax® Labeling with ONJ Warnings
After a January request from the FDA to update the Fosamax® label with information regarding the link between bisphosphonates and ONJ, Merck added the new warning to the drug's labeling information.
2005: Fosamax® Yearly Prescriptions and Sales Make It Merck's Second Best-Selling Drug
Despite the Fosamax® warnings issued in 2004, doctors in the United States wrote 22.4 million prescriptions for the drug in 2005. That same year, sales of the drug reached $3.2 billion, making Fosamax® Merck's second best-selling drug.
2006
April 2006: Fosamax® Lawsuit Filed in Florida
A Florida woman filed a lawsuit against Merck alleging that Fosamax® is a defective product that caused ONJ. The lawsuit further claimed that Merck was aware of the possible side effects of Fosamax® but instead of issuing warnings, it intentionally hid its findings.
April 14, 2006: Merck Issues Statement Regarding Fosamax® Side Effects
Merck placed a statement on its website regarding Fosamax® and its relation to osteonecrosis of the jaw. The statement lists Merck's own clinical studies, which show no correlation, and almost dismisses the post-marketing reports that suggest that Fosamax® may be linked to ONJ. The website states that Fosamax® labeling listed the proper warnings regarding bisphosphonates and jaw decay, but it avoids acknowledging any connection of their product with ONJ.
As the timeline has outlined, the FDA had to prompt Merck to properly list Fosamax® warnings on several occasions. Our pharmaceutical lawyers believe that you should not have been kept in the dark about potential Fosamax® side effects. If you or someone that you love has been injured by Fosamax®, contact the Fosamax® attorneys at Arizona-based Phillips and Associates for a free case evaluation.
June 2006: Hundreds Retain Phillips & Associates
By June 2006, Phillips & Associates had been retained by hundreds of clients who were harmed by Fosamax®. Currently, the firm is working to obtain the compensation these victims deserve and to convince Merck to proceed in withdrawing Fosamax® from the market. Please Call Now if you have any further questions. Our counselors are standing by 24 hours a day, 7 days a week at 1-800-706-3000. Call Now.