Warning! Warning! Two new safety stories from the FDA hit the press yesterday: One on Amgen's rheumatoid arthritis and psoriasis drug Enbrel, and one on older antipsychotic meds such as Haldol and Thorazine.
First, the agency wants to beef up labeling for Enbrel to include a warning that, when used in children, the drug carries the risk of death. Enbrel is up for pediatric approval for use in psoriasis--currently it's only approved for psoriasis use in adults -- and in preparation for the advisory committee discussion tomorrow, FDA staffers combed the adverse events database. They found some serious problems in kids using Enbrel, such as malignancies, infections, and neurological problems, many of them life-threatening--and some deadly. Given the fact that the number of children on Enbrel is fairly small, these serious adverse events are a red flag, FDA said. The agency is recommending that the label be changed, regardless of whether the drug gets the additional psoriasis nod.
Meanwhile, the FDA warned doctors that dementia patients using older antipsychotics appear to be at an increased risk of dying. A "black box" warning is going on the meds, which are sometimes used off-label to calm aggressive or out-of-control dementia patients. It's similar to the cautionary tale on newer antipsychotics, a.k.a. atypicals, which got a death-risk black box for dementia use three years ago.