Monday, 25 July 2011

Questions about the safety of Epogen and doses given

Epogen reduces the need for blood transfusions among dialysis patients, and counters the fatigue from long sessions. It's been in production since 1989.

But according to this news report (22 July, 2011), new guidelines have questioned the safety of this and related drugs. According to the report at Vcstar.com, "the FDA finally announced on June 24 new guidelines that are projected to slash the U.S. clinical use of Epogen by as much as a third. The FDA cited the increased risk of cardiovascular events ranging from stroke to death."

Links to the FDA's reports can be read on line and in more detail here (27 June 2011).

The FDA now requires a warning label about risks because of data showing increased risks of cardiovascular events with ESAs. The manufacturers have revised their labelling and on line information about the drug.