Fosamax Bone Problems Stand Out in ISMP Analysis of Adverse Events

Following an analysis of adverse event reports submitted to federal health officials, the Institute for Safe Medication Practices (ISMP) identified a strong correlations between use of the osteoporosis drug Fosamax and bone problems, highlighting the ability to use statistical tools to identify medications that may have side effects that are not numerous enough to stand out on their own.

In the latest issue of ISMP’s QuarterWatch report (PDF), the drug safety watchdog described a new method of mining FDA adverse event reports to discover links between specific drugs and potential side effects, while also flagging associations that may be statistical coincidence.

The report identified a strong association between side effects of Fosamax and bone problems, including reports of sudden femur fractures and osteonecrosis of the jaw (ONJ), a rare and debilitating condition where the jaw bone deteriorates and decays.

Investigators found that bone and joint injuries were reported 186 times more often than should have been expected for a drug over the period of one year. The report states that the “chances of a spurious association approached zero,” and called it one of the strongest drug-adverse event relationships observed during the entire year of 2012.

“The 1,327 cases reported in 2012 cannot resolve the question of whether long-term use of [Fosamax] is beneficial overall, or harmful,” the ISMP report notes. “It does provide a signal highlighting a key weakness in the system that allows millions of people to be exposed to long-term drug treatment where long term risks and benefits have not been determined.”

Fosamax Bone Damage Lawsuits

Fosamax (alendronate sodium) is a blockbuster medication that was introduced by Merck in 1995, for treatment and prevention of osteoporosis.  Before it became available as a generic in 2008, the medication generated over $3 billion in annual sales and was used by millions of Americans.

Thousands of former users of the medication are currently pursuing Fosamax injury lawsuits against Merck, alleging that the drug maker failed to properly research the medication or warn about the risk of severe bone problems from Fosamax.

In the federal court system, about 1,000 Fosamax ONJ cases may soon be remanded back to U.S. District Courts nationwide for individual trial dates, after the drug maker was unable to reach an agreement to settle the litigation following coordinated pretrial proceedings. All of the complaints involve allegations that use of Fosamax caused plaintiffs to suffer debilitating jaw decay and exposed bone in the mouth, often resulting in the need for surgery to remove portions of the jaw. Following contradictory rulings in a handful of early trial dates, the drug make is now expected to defend hundreds of individual cases in courts across the country.

Several thousand additional cases are also pending against the drug maker over spontaneous femur fractures on Fosamax, which allegedly occur with little or no trauma at all, such as falling from standing height or less. Since May 2011, the federal Fosamax femure fracture litigation has been centralized in the U.S. District Court for the District of New Jersey for coordinated handling.

The first Fosamax trial over a femur fracture was held earlier this year, with a defense verdict returned. However, additional test cases are scheduled for trial in New Jersey State Court, which a group of 30 femur fracture cases have been prepared for early trial dates before Judge Carol Higbee in Atlantic County, with case-specific discovery complete.