Image: Is risperidone safe for dementia patients

Over 40 million people live with dementia worldwide, and this number is expected to triple by 2050. The condition is more common in people over the age of 65 or older. However, with the steadily increasing elderly population in many countries, dementia represents a growing and important public health issue.

The first line of treatment for individuals with dementia includes environmental and social techniques. In some cases, however, antipsychotic drug use may be considered as a treatment option in later stages. Antipsychotics are often used to calm down dementia patients who can become agitated and aggressive, at times to the point of violence.

Among antipsychotic medications, however, risperidone is the most widely used for off-label purposes. These include treating psychosis, aggression, and agitation in people with dementia. But in the past decade, concerns have been growing over the safety of using risperidone in elderly patients with dementia.

This is mainly due to the increased risk of death that has been observed following the use of the drug in the population. Aside from that, risperidone, also known as Risperdal, is also linked to a condition called gynecomastia.

This is a disorder in which male breast tissue develops abnormally. Plaintiffs who have filed a Risperdal lawsuit even said that they lactated as a result of taking the drug as young males.

Moreover, according to federal authorities, the manufacturer aggressively marketed the medication to elderly patients, despite knowing the risks to the population.

What is dementia?

Dementia and Alzheimer’s disease are two conditions that can be mistaken as being only the same. And it’s not surprising at all, since their symptoms may overlap. However, there are key differences between the two.

And knowing these differences is beneficial for prompt management and treatment.

Dementia is an umbrella term used to describe symptoms that affect cognitive tasks, including memory, reasoning, and communication abilities. Alzheimer’s disease can fall under this group of symptoms, as well as vascular dementia and Lewy bodies, among others.

People can have multiple types of dementia. This is known as mixed dementia. People with mixed dementia usually have more than one condition that may contribute to their dementia. However, diagnosis of mixed dementia is only possible with an autopsy.

On the other hand, Alzheimer’s is the most common type of dementia. It is a progressive neurologic disease that slowly affects memory, thinking, and behavior. To date, the exact cause of the disease is not yet fully understood and no cure is available.

When is risperidone used for dementia?

Aside from memory loss, dementia can also be characterized by behavioral symptoms. These symptoms are thought to be targets for antipsychotic drugs.

Some of the behavioral symptoms common in dementia include:

  • Agitation
  • Aggression
  • Delusion
  • Apathy
  • Depression
  • Impulsivity
  • Hallucinations
  • Problem-solving difficulty
  • Difficulty controlling emotions

These are also called behavioral and psychological symptoms of dementia (BPSD). These symptoms add a burden to dementia patients by reducing their quality of life as well as their caregivers.

In the antipsychotic class of medication, atypical antipsychotics such as clozapine, aripiprazole, olanzapine, risperidone, and quetiapine are heavily favored in the treatment of severe dementia over the older typical antipsychotics because they can cause less extrapyramidal symptoms (EPS).

Clozapine is in fact the first atypical antipsychotic to be approved for other uses. However, risperidone gained more widespread use in the management of BPSD.

It’s worth noting that risperidone is only approved for BPSD in some countries, including Canada, Australia, the United Kingdom, and New Zealand. In these countries, the drug with the most evidence to back up its use in dementia is risperidone. It is approved for the short-term for up to six weeks management of persistent aggression in individuals with moderate to severe Alzheimer’s.

However, risperidone use only becomes an option when non-drug approaches have already been tried but failed.

The atypical antipsychotic medication is not approved by the U.S. Food and Drug Administration (FDA) for the management of behavior problems in older adults with dementia.

How effective is it in managing the condition?

A 2020 study summarized findings from systematic literature reviews and meta-analyses of clinical trials that pitted risperidone against other atypical antipsychotics or placebo.

The overall summary of findings suggests that as with other atypical antipsychotics, risperidone provides a modest yet significant benefit compared to placebo in managing agitation, aggression, and psychosis in individuals with dementia. However, risperidone can also cause some potentially serious adverse effects similar to other antipsychotics.

These potential adverse effects include:

  • Parkinsonism
  • Risk of falling
  • Increased mortality
  • Cerebrovascular adverse events (CVAE)

The increased risk of death and CVAE in elderly patients treated with antipsychotics ultimately led to the FDA requiring a boxed warning for risperidone as well as other antipsychotics’ label. A boxed warning is the strongest form of warning issued for a drug by the regulating agency. Its purpose is to alert consumers and doctors about potentially serious side effects that a drug may have.

Are there other antipsychotics used for dementia?

Risperidone is currently the only atypical antipsychotic approved in some countries for the management of severe BPSD. It’s worth noting, however, that positive clinical evidence has also been observed for other antipsychotics, including aripiprazole and quetiapine.

This may be because risperidone is the second oldest atypical antipsychotic medication on the market. Therefore, it has been used more widely in different studies.

In some cases, however, an older typical antipsychotic called haloperidol is approved for use in individuals with Alzheimer’s disease or vascular dementia. This also only applies in some countries mentioned in the preceding paragraphs.

However, most doctors consider its side effects in dementia patients to be too severe. This is why medical professionals only use haloperidol in emergency cases as a last resort.

What does the research say?

Despite growing safety concerns, risperidone remains a go-to choice for treatment in patients with AD and behavioral symptoms. In particular, the medication has been approved for this indication especially in people with more severe aggressive behaviors.

Indeed, in 2008, the European Union (EU) approved the drug for short-term or up to six weeks management of severe aggression in AD patients who have tried non-drug treatments but to no avail.

Meanwhile, Health Canada and The Australian’s Therapeutic Goods Administration who, in the past, approved risperidone for behavioral disturbances associated with dementia reviewed this decision in 2015 citing safety concerns over the drug.

As a result, they restricted risperidone use in patients with severe dementia of the Alzheimer type. Several studies have also investigated the potential effects of risperidone in dementia. Some of them may have conflicting findings. The results of these studies are further detailed and explained below.

JAMA Study

A 2020 study published in JAMA revealed that nearly three-quarters of older adults with dementia have filled prescriptions for medicines that carry several risks for them.

According to Medicare prescription records, 73.5% of the study’s community-based population filled at least one prescription for the following drugs:

  • Antidepressant
  • Opioid painkiller
  • Epilepsy drug
  • Anxiety medication
  • Antipsychotic drug

The study is based on data from 737,839 individuals with dementia. It’s the first large-scale study that looked into prescription-filling patterns for psychoactive medications outside of nursing homes and other facilities that cared for the elderly.

According to lead author Donovan Maust, M.D., M.S., a geriatric psychiatrist at the University of Michigan and VA Ann Arbor Healthcare System, nearly half of the participants received an antidepressant. This medication might have been prescribed to try to counteract the apathy and withdrawal often seen in dementia.

However, antidepressants don’t treat this aspect of dementia, Maust says. On the other hand, 29% of those in the study received opioids, while only one in five dementia patients filled a prescription for an antipsychotic medication such as Abilify, Seroquel, or Risperdal.

According to Maust, this is a bright spot in the data, considering the safety risks associated with these drugs. He also shared how they have received a lot of regulatory attention for the adverse events associated with antipsychotics.

However, compared to other drugs involved in the study, antipsychotics have more evidence that it actually helps patients with behavioral problems like aggression.

“So it is worrisome that all the other classes – which have less evidence of benefit – are all prescribed more widely,” says Maust.

Harvard Medical School Research

Researchers from Harvard Medical School found that other antipsychotic drugs are riskier than others when used in elderly patients with dementia. Before the study, the FDA warned that treatment with antipsychotic medications can cause increased mortality in the particular patient population.

Study authors reviewed data on over 75,400 elderly residents in nursing homes located in 45 states across the country.

Some of the findings of the study include:

  • Compared to patients treated with Risperdal (risperidone), patients who took Haldol (haloperidol) had twice the risk of death due to non-cancer-related causes in a span of six months. The largest number of deaths occurred during the first 40 days of treatment.
  • Patients who used the second-generation drug Seroquel (quetiapine) had a slightly lower risk for death compared to users of Risperdal.
  • The death rate among Abilify, Zyprexa, and Geodon users was similar to the death rate of patients who took Risperdal.

The study is the first to suggest that there’s a lower risk of death with Seroquel use compared to other newer atypical antipsychotic drugs.

What is the best antipsychotic for dementia?

The Harvard study included elderly patients who resided in nursing homes in the U.S. between 2001 and 2005. The participants were also new users of antipsychotic drugs.

The antipsychotics evaluated in the study were:

  • Abilify
  • Geodon
  • Haldol
  • Risperdal
  • Seroquel
  • Zyprexa

Compared to other second-generation antipsychotic drugs observed by the researchers, Seroquel carries a lower risk for death. The study is the first one to suggest this finding. However, according to researcher and Harvard Medical School instructor Krista Huybrechts, Ph.D., there’s a need for more studies to confirm this finding.

However, when it comes to the off-label use of antipsychotics, aripiprazole has been found to have the most consistent evidence of symptom improvement. But it’s important to note that this improvement is small.

Meanwhile, other antipsychotics like olanzapine, quetiapine, and risperidone have inadequate and inconsistent evidence of benefit for dementia patients. In an article published in the American Academy of Family Physicians (AAFP), it was recommended that physicians use the smallest effective dose for the shortest possible time to minimize adverse events due to antipsychotics, most notably an increased risk of death.

The conclusion of a 2020 study on the same topic supported this view. According to the study, treatment options for patients with BPSD should consider a positive risk-benefit ratio. The author added that with the current evidence on risperidone’s clinical effectiveness and safety in the management of BPSD, the use of the drug should be limited to patients with severe symptoms who haven’t had success with non-drug treatments.

A low dose and short period of treatment for up to 6 to 12 weeks were also recommended by the study. Furthermore, risperidone should be stopped after 12 weeks if there’s an increased risk for adverse events, or no significant benefit is observed.

Antipsychotics Still Over-prescribed

Although several studies have indicated that there’s less possibility for newer second-generation antipsychotics to cause extrapyramidal symptoms (EPS) compared to conventional antipsychotics, this doesn’t mean that the newer ones don’t come with risks.

In fact, atypical antipsychotics are found to be over-prescribed. According to recent data from the U.S. Department of Health and Human Services Office of the Inspector General, doctors tend to widely prescribe antipsychotics to elderly patients residing in nursing homes for off-label uses such as for dementia.

The audit also found that 51 percent of all claims had errors. This resulted in Medicare picking up the bill, although Medicare guidelines don’t allow for off-label prescription reimbursements.

Furthermore, this resulted in $116 million worth of antipsychotics such as Abilify, Risperdal, and Zyprexa being charged to Medicare by individuals whose conditions don’t exactly match the drugs’ intended uses.

With all these in consideration, it’s important to conduct a full assessment in a patient to look for severe dementia symptoms like agitation and aggression before antipsychotic drugs are prescribed.

What You Can Do

Although extrapyramidal side effects are more prevalent with the use of older, typical antipsychotics, risperidone can also cause these movement symptoms through a dose-dependent manner, particularly with doses above 6 mg/d.

Other risks associated with risperidone are gynecomastia and weight gain. Both can take a physical and emotional toll on a person. If you or a loved one experienced these side effects after taking risperidone, know that you’re not alone.

Several plaintiffs have already filed a Risperdal lawsuit citing these complaints. Contact us today if you want to pursue legal action against its manufacturer.

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