Some psychiatric drugs could prove fatal for elders suffering from dementia, US FDA warns.
The warning echoes a Canadian report in December on prescribing of anti-psychotics in seniors.
Antipsychotic drugs are approved to treat schizophrenia and bipolar disease, but doctors frequently prescribe them to treat elderly patients with dementia.
"The risks associated with these therapies outweigh the benefit. So you're dealing with a group of drugs where it's not really clear that they're useful. Yet they're still being widely used," said
Paula Rochon, a Toronto-based geriatrician.
Norma Galloway, an 85-year-old Vancouver native, was prescribed Risperdal when her son Rod requested a medication that would ease her anxiety about a persistent urinary tract infection.
Neither Galloway nor her son were ever told that the drug is intended for psychotic patients with severe dementia or schizophrenia. Following the doctor's directions, she took one pill in the morning and one at night.
Rod Galloway noticed a change in his mother immediately. "It was like someone that was really groggy or sedated and not really that with it," he said. "And on the next morning we were debating should we give her another one, and we reluctantly gave her a second Risperdal.
Norma Galloway's personality changed dramatically from cheery to sullen, her son said. One day she suffered a seizure in her room, something that had never occurred before, and collapsed. She was rushed to hospital.
She died after ten days in hospital. Her son says had he known about a Health Canada warning against such drugs, he would likely have refused to use such a powerful drug to deal with his mother's mild anxiety. He believes she would still be alive.
Rochon says antipsychotics should only be used in extreme cases. "Those would be [the] sort of situations where the person may be in danger of causing harm to himself or to other people around them and it's a very acute situation where you need to do something.
But usually the situation isn't that. Usually you have behavioural problems that are developing over time. And antipsychotics should be one of the last things you should consider in one of those settings."
The FDA's announcement was an update to a 2005 action, when regulators added warnings about increased heart attacks and pneumonia to drugs called atypical antipsychotics. The medicines include blockbusters like Eli Lilly and Co.'s Zyprexa, and Johnson and Johnson's Risperdal.
The FDA said Monday those same risks apply to 11 older drugs known as typical antipsychotics, including Pfizer's Navane and Endo Pharmaceutical's Moban. The drugs were developed in the 1950s and have largely been replaced by the newer medications, which are believed to have fewer side-effects, such as tremors.
Under FDA's orders, both drug types will now carry boxed warnings — the most serious a drug can carry — describing their risks to dementia patients, news agency AP said
The agency based its decision on two studies of a combined 65,000 seniors that showed those taking antipsychotics were more likely to die than those not on the drugs. Agency officials said it's not clear why antipsychotics hasten death. Scientists also could not determine from the data whether one group carries greater dangers than the other.
"We've struggled with this decision but we ultimately decided the data are strong enough to expand this label to drugs in both classes," said Thomas Laughren, director of FDA's psychiatric drug division.
The agency stressed there is "no approved drug for the treatment of dementia-related psychosis," and recommended doctors consider other treatment options.
"A lot of the things can be done to help change one's environment so elderly patients can be more oriented and engaged," said Dr. Eric Hollander, a professor at the Mt. Sinai School of Medicine.
Many of the behavioural problems in seniors can be improved with simple, daily routines that patients can follow, Hollander said.