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Antipsychotic drugs aren't specifically approved to treat dementia. They're mainly used to treat patients with schizophrenia. But people with dementia sometimes suffer delusions or hallucinations and may exhibit violent behavior. Doctors may prescribe antipsychotics to control these behaviors.
In 2005, the FDA warned that clinical trial data strongly suggested that newer "atypical" antipsychotics increase the risk of death in dementia patients. The agency required these drugs to carry its strongest "black box" warning on their labels.
Now, based on observational studies, the FDA warns that older antipsychotics also seem to increase dementia patients' risk of death. These drugs, too, will carry a black box warning.
"We just don't understand the mechanism, but there is an excess risk of mortality when these drugs are used for this indication," Thomas Laughren, MD, director of the FDA division of psychiatry products, said in a news conference.
Laughren stressed that the FDA is not telling doctors to avoid the use of antipsychotic drugs in dementia patients. The warning, he says, is meant to help families balance the risks of these medications against their benefits.
The new warning comes from observational studies that do not prove conclusively that the older drugs carry the same risk as the newer drugs.
"We struggled with this decision, but in the end we decided it was important to include the warning on the older drugs," Laughren said.
Older antipsychotic drugs are more likely than newer atypical antipsychotics to cause troublesome "extrapyramidal" symptoms such as tics and parkinsonism. But the drugs, many in use since the 1950s, are still being prescribed.
Older drugs that will carry the black-box warning are often known by their generic names. They include Compazine (prochlorperazine), Haldol (haloperidol), Loxitane (loxapine), Mellaril (thioridazine), Moban (molindrone), Navane (thithixene), Orap (pimozide), Prolixin (fluphenazine), Stelazine (trifluoperazine), Thorazine (chlorpromazine), and Trilafon (perphenazine).
Newer drugs that continue to carry the black-box warning include Abilify, Clozaril, FazaClo, Geodon, Invega, Risperdal, Seroquel, Zyprexa, and Symbyax.
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