Fosamax belongs to a class of drugs known as bisphosphonates that are
widely prescribed to post-menopausal women. Fosamax was approved by the FDA to treat or prevent
osteoporosis or bone loss in women.
These medications are intended to inhibit osteoclasts, cells that cause the breakdown of bone,
thereby making the bones thicker and less likely to break. In some situations, Fosamax can
have the opposite effect.
Fosamax has been associated with osteonecrosis of the jaw, a condition where the jaw essentially
rots away. The FDA concluded that labels accompanying bisphosphonates should warn patients
of the risk of osteonecrosis.
In August 2005, the manufacturer of Zometa and Aredia, drugs
similar to Fosamax, added such a warning. As of May 2006, Merck, the manufacturer of Fosamax,
has failed to include a warning on the label for osteonecrosis. The only warning related to
the condition is included on page 13 of a 22 page report given only to pharmacies, a warning
clearly inadequate given the risk.
Merck has been under fire for failing to warn physicians and patients of the serious
risk presented by Vioxx, another drug manufactured by the company. Vioxx was withdrawn from
the worldwide market in September 2004, several years after the company was aware that the
drug greatly increased the risk of heart attack and strokes in patients.