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Osteoporosis drugs may lead to unusual thigh fractures, FDA warns
by Neha Gupta - October 14, 2010 - comments
Though the thigh fractures also can occur from osteoporosis, the ones reported in recent years were unusual because they often appeared after little or no trauma and were seen in younger patients.
Osteoporosis drugs, which are meant to prevent bones from breaking, may elevate the chances for an unusual type of thigh fracture, U.S. health officials warned on Wednesday.
The drugs, commonly known as bisphosphonates, include Merck's Fosamax, Roche Laboratories' Boniva, Novartis's Reclast and Warner Chilcott's Actonel, and these are consumed by million of women worldwide.
After the study revelation, many patients have begun seeking alternatives like Amgen Inc's just-launched rival medicine, Prolia, a different type of osteoporosis drug that is the company's most important future growth driver.
"Today's label change is likely to raise the level of concern among patients about the safety of bisphosphonates significantly," Bernstein & Co analyst Geoff Porges said in a research note.
Research findings
A research on the hospital discharge data has revealed that the rate of hip fractures dropped to 428 from 598 per 100,000 people in the 10 years after approval of the first bisphosphonate in 1996.
The most commonly occurring fractures seen with osteoporosis were those of the hip, wrist or spine.
Patients with symptoms like a dull, aching pain in the thigh or groin should contact a doctor to try and prevent the fracture.
Though the thigh fractures also can occur from osteoporosis, the ones reported in recent years were unusual because they often appeared after little or no trauma and were seen in younger patients, the FDA's Kweder said.
Drugs to carry warning note
Now onwards, all bisphosphonates used for osteoporosis would carry a warning about rare but serious fractures of the thigh bone.
The new warning "should not cause patients taking bisphosphonates to be fearful of their medicine," said Dr. Sandra Kweder, deputy director of the FDA's new drugs office.
The drugs "are an important mainstay of osteoporosis management" and "have prevented innumerable fractures in their years of use," Kweder told reporters on a conference call.
Doctors are also being advised to examine if the patients on therapy for more than five years still need the drugs.
Patients with symptoms like a dull, aching pain in the thigh or groin should contact a doctor to try and prevent the fracture.
Osteoporosis is a progressive bone-thinning condition most common in women after menopause.
While Actonel and Reclast are injectable, the other drugs are taken orally.