Osteoporosis drug Fosamax linked to serious diseases
A CLOSER LOOK: OSTEOPOROSIS DRUG
Studies suggest the drug could raise the risk of cancer of the esophagus and a bone-killing infection in rare cases.
Two recent reports have linked the osteoporosis drug alendronate (Fosamax) with rare but serious side effects.
In a letter to the New England Journal of Medicine published Jan. 1, a Food and Drug Administration official reported that since Fosamax was first marketed in 1995, 23 cases of esophageal cancer in patients taking the drug -- including eight deaths -- have been reported to the agency. And a USC study published in the January issue of the Journal of the American Dental Assn. reported that nine patients who were taking Fosamax suffered osteonecrosis of the jaw -- a bone-killing infection -- after having teeth extracted at USC dental clinics.
The number of cases in these reports is too small to determine the extent of risk for someone taking the drug, but doctors and dentists are likely to take more precautions with patients taking or considering taking Fosamax or similar drugs, say Dr. Robert Rude, a professor of medicine at USC, and Parish Sedghizadeh, the dentist who led the USC study.
Bone-building drugs: An article in Monday's Health section on side effects of oral versions of bone-building drugs called bisphosphonates said that zoledronic acid (Reclast) is available as a pill. It is delivered by injection.
Bone-building drugs: A Jan. 12 Health section article on side effects of oral versions of bone-building drugs called bisphosphonates said that zoledronic acid (Reclast) is available in pill form. It is delivered by injection.
Who takes Fosamax or related drugs?
An estimated 30 million Americans take Fosamax or some other oral bisphosphonate: ibandronate (Boniva), risedronate (Actonel) and Reclast (zoledronic acid). These drugs have dominated the osteoporosis market based on their effectiveness at slowing bone loss, their convenience (available in pill forms) and the movement away from hormone replacement therapy.
A typical patient is a postmenopausal woman with bone density T-scores of negative 2.5 or lower (the definition for osteoporosis). Men also experience bone loss with age and are prescribed oral bisphosphonates.
What is the cancer risk?
Dr. Aurelia Nattiv, director of the Santa Monica-UCLA Osteoporosis Center, says that the true prevalence of esophageal cancer in individuals taking Fosamax cannot be determined yet.
"Further study is warranted -- with a large population base -- to determine if esophageal cancer in those taking Fosamax [and other oral bisphosphonates] is higher than in the general population," she says, where the prevalence of esophageal cancer is 5 per 100,000. She advises caution until such data are available.
Can the cancer risk
be minimized?
