Just How Safe is Feraheme?

NEW YORK (Dow Jones)--AMAG Pharmaceuticals Inc. (AMAG) shares gained in after-hours trading Friday as the biopharmaceutical company gave a safety update on its anemia drug, Feraheme, that appears to have reassured investors.

Concerns about the drug's safety were sparked Thursday by an analyst report that said field checks show there have been serious adverse events with the drug, and it was unclear if those events were occurring at a rate consistent with that on the drug's label.

AMAG's release after the market's close Friday said serious adverse events have been reported at a rate consistent with that contained in the U.S. package insert. Of the estimated 35,000 patient exposures to date, 40 serious adverse events have been reported, an approximate rate of 0.1%.

The company also said Friday that no mortality signal has been observed. A single reported death occurred in a patient two days post-Feraheme treatment, which the company does not believe was the result of Feraheme.

It has been a roller coaster for AMAG. Full disclosure, I stock and administer Feraheme in my office. I have had a couple of reactions which has caused me to question the safety as well. I am not completely satisfied with the adverse events and believe there may be some merit to rechecking the safety of this agent. I am glad for AMAG and their shareholders with the rebound in stock price... but, my office will be switching to another IV iron drug.