FDA Advisors OK Osteoporosis Drug

Promising new help against crippling osteoporosis, government advisors recommended on Thursday approval of a drug that mimics estrogen’s bone-saving effects without the breast cancer risk.

The long-awaited raloxifene does not protect bones as well as estrogen, the gold-standard treatment, advisors to the Food and Drug Administration said Thursday.

“I’d like to refer to it as ‘estrogen light.’ It does the same thing as Premarin but not as well,” said Dr. Glenn Braunstein of Cedars-Sinai Medical Center in Los Angeles, referring to the top estrogen brand.

Doctors told the advisors that raloxifene could be an important option for women who are afraid of estrogen because of the increased cancer risk from long-term use. Others simply won’t take it because it brings back their menstrual periods, said Dr. Ethel Siris of Columbia University.

The FDA advisors voted, 8 to 4, to recommend approval of raloxifene, to be sold by Eli Lilly & Co. under the brand name Evista. The FDA is not bound by the advice of its panels but usually follows it.