Dementia

Study: Antipsychotics hike stroke risk for all

Tracy Staton — Fri, 29 Aug 2008 10:02:55 -0400

The risk of stroke among patients taking antipsychotics may be more widespread than we thought. British researchers are saying that the risk accompanies all antipsychotics--not just the newer "atypicals" like Abilify and Zyprexa, as once thought. And all patients on these drugs have a greater risk--not just those with dementia, the researchers found.

The study looked at 6,790 patients with an average age of 80. It's true that the stroke risk was slightly higher for people taking atypicals versus the older antipsychotics such as Thorazine and Haldol. And the risk of stroke was also much greater in dementia patients (their risk actually tripled). But even patients without dementia saw their stroke risk magnified by 40 percent.

Echoing an FDA warning on the atypical meds, researchers said that patients with dementia shouldn't be taking these drugs--or their older brethren, either. Alzheimer's expert Dr. Sam Gandy said the new study "elevates the concern about risks of antipsychotics to a whole new level." The FDA might want to investigate, he said.

- read the story in the Washington Post
- check out the BBC article

Wrong drugs used in dementia, experts say

Tracy Staton — Tue, 24 Jun 2008 07:49:13 -0400

The debate over drug use in dementia patients continues apace. A New York Times article today trots out the stats--about one-third of nursing home patients have been prescribed antipsychotics, for instance--and reviews the evidence that antipsychotics new and old are overused in patients with dementia. Experts told the paper that they should be used as a last resort to calm patients who are self-destructive or violent.

As you know, several states are suing makers of atypical antipsychotics, alleging false and misleading marketing. The U.K. is reviewing use of the meds in dementia patients. And the FDA recently added a warning of the increased risk of death among dementia patients who use old-style antipsychotics; the atypicals have carried such a warning since 2005.

While antipsychotics might be overused, there's a class of drugs that may not be used enough: antidementia meds like Eisai's Aricept and Novartis' Exelon. Up to 20 percent of Alzheimer's patients noticeably improved on the drugs, and 40 percent more showed some cognitive improvement that wasn't as readily apparent. Plus, some nursing homes are trying nondrug treatments. Simply by paying more attention to residents, these facilities are getting results. The problem is, they're time-consuming--and thus expensive.

- read the NYT story

Enbrel, antipsychotics draw warning fire

Tracy Staton — Tue, 17 Jun 2008 11:04:57 -0400

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.

- see the Wall Street Journal article
- check out the Washington Post story