FRIDAY, March 25, 2005 (HealthDay News) -- A once-a-month pill to combat the bone-weakening condition
osteoporosis was approved Thursday by the U.S. Food and Drug
Administration.
Boniva (ibandronate sodium), produced and sold by drugmakers
GlaxoSmithKline and Roche, is the first monthly bone density-building
drug, the companies said in a statement. They estimate that some 44
million Americans over age 50 -- mostly women -- are at risk for the
disease.
The bone-weakening effects of osteoporosis can lead to severe pain,
fractures, deformity, hospitalization, and even death, the companies
said.
The safety and effectiveness of Boniva were established during
clinical trials involving 1,602 women with postmenopausal osteoporosis,
the companies said. The most common side effects included high blood
pressure, abdominal pain, upset stomach, nausea, and diarrhea.
The prescription medication is expected to be available in the United States sometime in April, the drugmakers said.
The FDA has more about osteoporosis on its Web site.
