Feb. 1 (Bloomberg) -- Daiichi Sankyo Co.'s drug Injectafer should be sold in the U.S. as a backup treatment for iron deficiency anemia, a panel of U.S. advisers recommended, even though regulators had expressed concern about safety risks.

The drug, given intravenously, should be used only when oral medications don't work or can't be tolerated, a Food and Drug Administration advisory panel said in a 10-5 vote today at a meeting in Silver Spring, Maryland.

Daiichi wants to market Injectafer for iron deficiency anemia in women after childbirth and those with heavy uterine bleeding. The company proposed selling the medication as a primary treatment. The drug was linked in studies to more deaths than comparable treatments, raising ``significant safety concerns,'' FDA staff wrote in a document that was posted this week on the agency's Web site.

``There's a signal that the drug might increase the risk of death,'' said Sean Hennessy, the panel's chairman and a professor of epidemiology at the University of Pennsylvania School of Medicine in Philadelphia, in an interview after the vote. ``While it's only a signal, you want to take it seriously.''

The risk of death ``may be outweighed by the benefit'' of the drug, he said. Many women suffer nausea and constipation from iron pills and Injectafer may be a good alternative, panel members said.

The agency usually follows the advice of its advisory panels, although it isn't required to do so. The FDA is expected to make a decision by mid-March, the company said.

The treatment is approved for sale in Europe under the name Ferinject. Swiss drugmaker Galenica AG licensed the U.S. version to Tokyo-based Daiichi.

Daiichi fell 60 yen, or 1.9 percent, to 3,130 in Tokyo trading before the meeting. Galenica rose 17 Swiss francs, or 4.7 percent, to 382 in Zurich trading. The company fell 17 percent, the most since at least 1989, after the FDA staff report was released on Jan. 30.

3 Million Women

About 3 million women of childbearing age in the U.S. have been diagnosed with iron deficiency anemia, according to Daiichi. The condition, in which the number of red blood cells is abnormally low, can result from bleeding, according to the National Institutes of Health.

The company is pleased with the panel's discussion, even though the advisers endorsed a more restrictive use, said Mary Jane Helenek, president and chief executive officer of Luitpold Pharmaceuticals, a U.S. unit of Daiichi, in an interview.

``I believe we're walking away with a path forward,'' Helenek said.

No intravenous drugs are approved for the uses the FDA is considering for Injectafer, analyst Carol Werther, of Summer Street Research Partners in Boston, said in an interview.

Patients typically are given over-the-counter iron pills, said Richard Branda, a professor in the hematology and oncology division of the University of Vermont in Burlington, in an interview. On occasion, doctors may use the intravenous drugs Venofer, sold by Daiichi, and Ferrlecit, sold by Watson Pharmaceuticals Inc., which are approved for other types of iron deficiency anemia, he said.

Once drugs are cleared for sale, doctors are free to prescribe them for uses other than those approved by the FDA, although companies aren't supposed to market the products for unapproved purposes.

Ten Patients Died

Ten patients died after receiving Injectafer in the company's studies, according to the FDA. One patient died taking Venofer, the drug used for comparison. Five of the 10 Injectafer-related deaths stemmed from heart trouble, the FDA review found.

``None of the deaths were related'' to Injectafer, said Walter Tozzi, director of marketing and professional services for American Regent, a unit of Daiichi, in an interview today. ``The drug is safe.''

Daiichi originally applied to sell Injectafer to treat anemia linked to childbirth, heavy uterine bleeding, inflammatory bowel disease and dialysis. The FDA rejected the application on concerns about patient deaths, so the company submitted a new analysis and revised its proposal in November to include only women after childbirth or those with heavy uterine bleeding, according to the agency document.

Amag Pharmaceuticals Inc., based in Cambridge, Massachusetts, is developing a similar anemia treatment called ferumoxytol.

To contact the reporter on this story: Justin Blum in Silver Spring, Maryland, at jblum4@bloomberg.net.

Last Updated: February 1, 2008 17:24 EST