(NaturalNews) The FDA has ordered the makers of older, "conventional" antipsychotics to add a "black box warning" to the drugs labels about the risk of early death in elderly dementia patients who take them. This is the strongest warning that can be placed on a medication without pulling it from the market.
This marks the first time that the FDA has used its new authority to mandate stronger warning labels on drugs. Before 2007, the FDA only had the power to request changes to warning labels.
The FDA concluded that conventional antipsychotics pose the same risks to elderly dementia patients as the newer, so-called "atypical" antipsychotics.
"The warning for both classes of drugs will say that clinical studies indicate that antipsychotic drugs of both types are associated with an increased risk of death when used in elderly patients treated for dementia-related psychosis," the agency said.
In 2005, atypical antipsychotics received a black box warning after studies found that they increased the risks of heart attacks and pneumonia among elderly dementia patients, and that patients who were given the drugs died sooner than those who were not. In one such study cited by the FDA, 50 percent of elderly dementia patients died after ten weeks of treatment with the drugs, compared with only a 2.6 percent death rate among those taking a placebo.
Antipsychotics were designed for the treatment of schizophrenia, and are not approved for the treatment of dementia. Nonetheless, doctors are allowed by law to prescribe according to their own judgment, and antipsychotics are often used to sedate elderly dementia patients who develop psychosis-like symptoms, such as aggression, agitation, hallucinations or delusions.
Many patient advocates have accused many nursing home staff of shortening patients' lives by giving them drugs that are only designed to sedate, rather than treat them.
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