Fosamax may do more harm than good
Fosamax, the osteoporosis drug that Merck put on the market more than a decade ago, is promoted by instilling in women a fear of hip fractures and the need for regular bone-density tests. It belongs to a class of drugs known as bisphosphonates and is also used for advanced forms of bone cancer.
Although Fosamax does improve bone density, its ability to prevent fractures is modest at best. Some researchers contend that, when taken for more than 10 years, it actually makes bones more brittle and vulnerable to fractures. “Many people believe that these drugs are ‘bone builders,’ but the evidence shows they are actually ‘bone hardeners,’” wrote Dr. Susan Ott in the Annals of Internal Medicine.
A number of studies have shown a link between Fosamax and osteonecrosis of the jaw (ONJ ), a condition in which bone tissue in the jaw fails to heal following minor traumas such as tooth extraction, leaving the bone exposed. That exposure can eventually lead to infection, fracture and even surgery to remove dying bone tissue. Such Fosamax side effects have caused patients to become bedridden, or require walkers, crutches or wheelchairs.
On April 10, 2006, a lawsuit was filed against Merck in a U.S. district court in Florida. It alleged that (1) Fosamax is a defective product that can cause ONJ, (2) Merck concealed dangerous Fosamax side effects from doctors and patients, and (3) Merck has yet to comply with the FDA’s request to add an ONJ warning to the drug’s label.
The Fosamax attorney in that case wants that lawsuit to have class action status, claiming that it may eventually represent more than 10 million plaintiffs. Fosamax, which had revenues of $3.2 billion in 2005, may turn out to be as costly for Merck as Vioxx, the company’s arthritis and painkilling drug which was recalled in 2004 due to side effects of heart attack and stroke. Some analysts think the various Vioxx lawsuits may cost Merck from $20 to $30 billion.