Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: FRIDAY, November 18, 1994 TAG: 9411180114
SECTION: NATIONAL/INTERNATIONAL PAGE: A-2 EDITION: METRO
SOURCE: Associated Press
DATELINE: GAITHERSBURG, MD. LENGTH: Medium
An FDA advisory committee concluded that the drug etridonate had not been proven to reduce spinal fractures among osteoporosis patients even though the drug did increase bone mass and appear to help the worst cases.
After the 6-3 vote against approving the drug, doctors predicted patients would continue receiving it anyway from physicians who don't know what dose to prescribe.
``This is currently being used widely and I've seen it used incorrectly,'' said Dr. Ethel Siris of Columbia University, an FDA adviser who favored the drug.
``Please do whatever you can to makes sure effective drugs to fight this life-diminishing disease are made available to us who need it so desperately,'' said Aileen Knapp, 71, of Washington, who credits the drug with slowing her osteoporosis. She was one of 10 patients who pushed for the drug's approval at the hearing.
Osteoporosis causes bones gradually to become very brittle. It afflicts 25 million Americans, 80 percent of them women, and about 200 million people worldwide. The disease causes 1.5 million bone fractures a year and 50,000 deaths. Its risk increases with age.
Only two drugs in the United States are approved to fight it: estrogen, for post-menopausal women; and a thyroid-produced hormone called calcitonin that must be injected once a day. Hormones have frequent side effects and many women can't take estrogen if they are at high risk for breast cancer.
The proposed drug, sold by Procter & Gamble Co. under the name Didrocal, is approved by the FDA for use against another serious bone condition known as Paget's disease. Even though it is not authorized for osteoporosis, many sufferers from that disease obtain it by prescription from their doctors.
It is not uncommon for physicians to prescribe medicines for purposes unapproved by the FDA, and doctors who do this are not prosecuted. However, some doctors are reluctant to prescribe Didrocal without the agency's backing and without knowing the optimal dose.
Procter & Gamble said Thursday that osteoporosis patients should take 400 milligrams of Didrocal a day for 14 days and then take calcium, vital for bone growth, for the next 76 days in a continuing cycle, presumably for the rest of their lives.
One study showed that women who followed this pattern for three years had twice the chance of remaining fracture-free over patients who took only calcium.
by CNB