Merck Failed To Warn About Fosamax Adverse Side Effects In A Timely Manner

FDA Told Merck Osteoporosis Drug Linked To Osteonecrosis of Jaw in 2004; No Warning Added To Fosamax Label Until 2005

For almost a year, Merck & Co. failed to warn doctors and patients about osteonecrosis of the jaw (rotting of the jaw bone), a serious side effect that has been associated with its osteoporosis drug Fosamax (alendronate).

In August 2004 the FDA's Office of Drug Safety issued its Postmarketing Safety Review report about Fosamax -- an osteoporosis drug made by Merck & Co. -- as well as three other bisphosphonate drugs: Zometa; Aredia; and, Actonel. The August 2004 FDA report concluded that the label, or package insert, for Fosamax should be revised to include a warning about osteonecrosis, a rare but serious side effect observed in some patients who used Fosamax.

Despite the recommendation from the FDA, Merck did not revise the Fosamax label to include any type of warning about osteonecrosis of the jaw (also known as ONJ) until July 2005 -- almost a year after the FDA's August 2004 report. In addition, critics have asserted that the July 2005 label change was not sufficient to alert doctors and patients about the ONJ side effect linked to Fosamax .

Meanwhile, Merck has continued to market Fosamax aggressively and successfully. U.S. doctors wrote 22.4 million prescriptions for Fosamax in 2005, resulting in $3.2 billion in sales and making it the top-selling osteoporosis drug in the U.S. Fosamax is Merck's second best-selling drug overall. Despite the FDA's findings, Merck continues to deny that Fosamax has been linked to osteonecrosis of the jaw.

Because Merck failed to change the side effects warnings for Fosamax in a timely manner, lawsuits are being filed against the drug company by Fosamax users who have developed osteonecrosis of the jaw, which is an irreversible condition. The Fosamax lawsuits allege that Merck concealed what it knew about Fosamax causing osteonecrosis of the jaw from patients and their doctors -- which is similar to what Merck previously did with its infamous painkiller, Vioxx, a couple of years earlier.

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