A group of drugs that can have serious adverse effects when used by the elderly continues to be widely prescribed in Canada and the United States, despite concerns about their safety.
The drugs, called atypical antipsychotics, are used to manage the behavior of seniors who have dementia, but many experts consider them to be dangerous and possibly ineffective in elderly patients.
In 2005, both Health Canada and the Food and Drug Administration (FDA) in the United States warned that atypical antipsychotic medications increased the risk of death among elderly patients with dementia.
The Health Canada warning stated that in 13 scientific studies, elderly patients with dementia who were prescribed atypical antipsychotics had a 60 percent higher death rate on average than similar patients taking placebos.
Yet according to a recent investigation by CBC News, the number of prescriptions of these drugs for seniors has actually risen since the Health Canada warning. The increases—in some cases as high as 40 percent—happened in six provinces, including Quebec and Ontario.
In its initial investigation into this issue in 2005, the Canadian Broadcasting Center (CBC) reported that over a million seniors were being prescribed dangerous drugs, including atypical antipsychotics. The Health Canada warning came on the heels of that report.
Some of the most serious adverse reactions in seniors to atypical antipsychotics are heart failure, stroke, and death.
"This class of drugs is probably the most toxic of the drugs that are being given to the elderly," says Alan Cassels, a University of Victoria drug researcher and author of Selling Sickness: How the World's Biggest Pharmaceutical Companies Are Turning Us All Into Patients.
The Health Canada warning advised physicians not to rely too heavily on atypical antipsychotics to treat dementia. So why continue to prescribe drugs that may do more harm than good?
"It's really hard to counter the marketing of the pharmaceutical companies," says Cassels. In addition, doctors "get absolutely flooded with stuff from the pharmaceutical companies, and it's very hard for them to sift through all that to find information."
In a CBC article last Wednesday, Dr. John Haggie, a Canadian Medical Association board member, said government warnings tend to get lost in the large volume of literature physicians regularly receive from drug companies.
Health Canada listed four drugs that could pose risks for seniors: Risperidone (Risperdal), Quetiapine (Seroquel), Olanzapine (Zyprexa) and Clozapine (Clorazil).
According to CBC, Risperidone is the only atypical antipsychotic that has actually been approved for patients with severe dementia.
Atypical antipsychotic medications were developed for the treatment of schizophrenia in patients under 65.
Older people are known to process drugs more slowly, with the result that they can react to treatments that would not be problematic in younger people with stronger metabolisms. However, atypical antipsychotics are rarely tested on the elderly, says Cassels.
"The whole issue of prescribing to the elderly is controversial because there isn't a lot of good evidence on what these drugs do in older people."
Dr. Paula Rochon, a senior scientist and geriatrician at Toronto's Baycrest Geriatric Healthcare System, says this group of drugs was designed for people who have psychosis or severe behavioural problems—those who may be a danger to themselves or the people around them.
And while the drugs can be beneficial to people with major psychiatric problems, it's important to balance the risk against the benefits, says Rochon.
"What we're worried about is when we're not sure the drug is providing benefit—or may not be providing benefit—and it is associated with risk. These are drug therapies that you need to think carefully about before you prescribe."
Rochon says there are also concerns that atypical antipsychotics are being prescribed for conditions other than dementia, adding that the drugs are inappropriate for such problems as insomnia or wandering in Alzheimer's disease patients.
Because the drugs cause drowsiness, there's an increased risk of falls. They also cause tremors, and Rochon says people taking the drugs are often diagnosed with Parkinson's disease, when it's actually a side effect of the medication.
In addition, atypical antipsychotics can interfere with blood sugar metabolism, causing diabetes in some patients. A number of lawsuits have been launched against drug giant Eli Lilly, the maker of Zyprexa, because of the drug's links to diabetes and diabetes-related disorders.
"There are lawsuits around these drugs all the time," says Cassels.
The FDA issued a warning in 2003 and asked Eli Lilly and other manufacturers of atypical antipsychotics to alert doctors of the increased risk of diabetes and hyperglycemia associated with the drugs. Health Canada also requested that the drug makers provide information to health professionals of the drugs' risks.
In 2005, the FDA asked manufacturers of several antipsychotic medications, including Zyprexa, to add a "black box" label warning of an increased risk of death among elderly patients with dementia taking these drugs.
In 1991 in the United States, a team of 12 health experts led by Dr. Mark Beers compiled a list of potentially dangerous drugs for seniors. Since then, the Beers Criteria has been widely used to improve prescribing says Donna Fick, a geriatric nurse specialist and associate professor of nursing at Pennsylvania State University.
However, large numbers of seniors are still being prescribed atypical antipsychotics.
"The Beers Criteria has been out since 1991 and studies are still showing very high use of these drugs—maybe even more so" says Fick, who updated the Criteria in 2003.
While non-drug therapies could be effective and appropriate in many situations, says Fick, both patients and their family members often want fast answers, and "it's quicker to write a prescription."
"I believe that physicians want to provide the best care for patients just like all health professionals, but these are challenging times to do that."
Cochon says the elderly people "being targeted for these therapies" are a very vulnerable group, and advises caregivers and family members of patients with dementia to seek the advice of a pharmacist when making decisions about drug therapy.
"They're really the drug experts who can help with deciding if the drug can be useful and provide very important information that can prove educational for everybody."
Cassels says Health Canada should be more proactive in collecting research on adverse drug reactions and in ensuring that physicians actually see the warnings it sends out.
He also believes there needs to be "more of a firewall" between doctors and the drug companies.
"I would really like to see our doctors spending less time getting educated by the drug companies, because I don't think it results in good prescribing. In fact, good research shows that the more contact physicians have with the drug companies, the worse prescribers they become."
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