Risperidone (pronounced ris-pair-ih-doan) is a second generation or atypical antipsychotic, sold under the trade name (Risperdal). It is used to treat schizophrenia (including adolescent schizophrenia), schizoaffective disorder, the mixed and manic states associated with bipolar disorder, and irritability in people with autism. It is associated with significant weight gain and metabolic problems, as well as tardive dyskinesia and neuroleptic malignant syndrome. The drug was developed by Janssen-Cilag and first released in 1994.
Risperdal (Risperidone) - Adverse Event Reports - Death - Diabetes Mellitus
Here is a selection of adverse event reports related to Risperdal (Risperidone) that includes cases resulting in death where reactions include diabetes mellitus. See Report
Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal side effect reported with RISPERDAL ® and similar medicines. Call your doctor immediately if the person being treated develops symptoms such as high fever; stiff muscles; shaking; confusion; sweating; changes in pulse, heart rate, or blood pressure; or muscle pain and weakness. Treatment should be stopped if the person being treated has NMS. See Report
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The use of clozapine is associated with side effects, many of which are minor, though some are serious and potentially fatal: the more common include extreme constipation, night-time drooling, muscle stiffness, sedation, tremors, orthostasis, hyperglycemia, and weight gain. The risks of extrapyramidal symptoms such as tardive dyskinesia are much less with clozapine when compared to the typical antipsychotics; this may be due to clozapine's anticholinergic effects. Extrapyramidal symptoms may subside somewhat after a person switches from another antipsychotic to clozapine.
Clozapine also carries eleven black box warnings for agranulocytosis, CNS depression, leukopenia, neutropenia, seizure disorder, bone marrow suppression, dementia, hypotension, myocarditis, orthostatic hypotension and seizures. Lowering of the seizure threshold may be dose related and slow initial titration of dose may decrease the risk for precipitating seizures. Slow titration of dosing may also decrease the risk for orthostatic hypotension and other adverse cardiovascular side effects. See Report
Clozapine (Clozapine) - Adverse Event Reports - Death
Here is a selection of adverse event reports related to Clozapine that includes cases resulting in death. See Report
The TGA received over 17,000 adverse reaction reports in 2009-10, which was an increase of more than 7000 reports from 2008-09.
The increase in report numbers was largely attributable to the H1N1 influenza vaccination program, which used a variety of strategies to encourage consumers and health professionals to report adverse events, facilitating close monitoring of the vaccine's safety (see Medicines Safety Update Issue 4, August 2010). General practitioners contributed 1720 reports and pharmacists 790 reports. See Report
Hundreds of deaths linked to schizophrenia drug clozapine
From March 24, 2009
Fifty people die each year and hundreds more suffer serious side-effects as the result of taking powerful tranquillisers prescribed by the NHS, The Times has learnt.
Data from the medicine watchdog’s own reporting scheme suggests that clozapine, a drug taken by schizophrenia patients, has been linked to 950 deaths since being licensed in 1990 — equivalent to nearly one fatality a week.
Recent figures record the deaths of 55 people taking the medication in four months, from October to January, despite the drug being prescribed to relatively few people.
The anti-psychotic drug is used as a treatment of last resort for schizophrenia patients but appears to increase the chances of having a heart attack or stroke, or of suffering other long-term health problems that are not adequately monitored by current checks, campaigners say. More than 11,600 adverse reactions linked to clozapine have been reported in 19 years, according to the Yellow Card reporting scheme of the Medicines and Healthcare products Regulatory Agency (MHRA), which is designed to flag up potentially harmful side-effects for licensed drugs. See Report
Zyprexa (Olanzapine) - Warnings and Precautions
Hyperglycemia and Diabetes Mellitus -- Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics including olanzapine. Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population. See Report
FDA Finds Zyprexa Has Killed 3,400 People, Worse Than Vioxx
November 17, 2008
I was reviewing an FDA staff document this morning, wherein FDA staffers recommend additional warnings for Zyprexa for pediatric cases (ie, teens) and ran across a startling statistic. According to the agency's own adverse events database summarized in the report, the controversial atypical antipsychotic has killed 3,455 people (see page 7 of the above document) between 1997 and early 2008.
Roughly half of the deaths are known to have occurred in the US while the remainder are from unidentified locations (likely a mix of US and foreign deaths).
What startles me is that last fall I reported on a study of the FDA's adverse events database in which researchers reported that Zyprexa had killed 1,005 people from 1998 to 2005, so this new accounting represents a large increase in deaths associated with the drug. Even more, according to that same study, Vioxx had killed 932 people. So why do Vioxx cases get all the media attention while Zyprexa does not? Why is Zyprexa still on the market and raking in $4 billion or so a year in sales while Vioxx is off the market?
Why on earth has this drug been marketed for casual use far beyond its initial use as an antipsychotic?
As of now, Zyprexa is not approved for use in children and teens, but Eli Lilly has an application before the FDA to gain approval for its use in teens diagnosed with schizophrenia. Amazingly, one published study of Zyprexa in teens found that in a three-week trial of the drug patients gained an average of eight pounds, which is a lot for such a short time period. That's why the FDA staff in the above document is recommending additional warnings about weight gain in pediatric populations.
Schizophrenia is a chronic mental illness that impairs a person's thinking, judgment, interpretation of the world around them and ability to function in society. As a result of their inability to correctly interpret the world around them, people with schizophrenia may react inappropriately. They can feel frightened, nervous and confused.
People with schizophrenia may experience different types of symptoms - and not everyone experiences the same symptoms. Some people may have only a few symptoms, while others may have many. Generally, these symptoms fall into two different categories: "positive" symptoms and "negative" symptoms. A person with positive symptoms exhibits signs of "added" experiences or behaviors. When a person demonstrates a "lack of" or "reduction" of experiences or behaviors, he or she may have negative symptoms.
Positive symptoms may include:
Delusions - belief in ideas that are obviously false
Hallucinations - seeing or hearing things that do not exist
Agitation - nervousness
Paranoia - suspiciousness or unrealistic fears
Impulsiveness - taking action without really thinking about what one is doing
Disorganized thinking - unclear or confused thoughts
Negative symptoms may include:
Lack of drive or initiative - daily activities cannot be accomplished (e.g., bathing)
Social withdrawal - isolate oneself from friends, family, and the public
Apathy - lack of feeling or emotion
Emotional unresponsiveness - having no feeling towards anything, the person would not cry if sad, show anger if mad, or smile/laugh when happy
Anhedonia - diminished ability to experience pleasure
You may have heard the term "psychotic" used in association with schizophrenia. A psychotic episode is a state of mental impairment, during which a person experiences hallucinations and/or delusions, or has disorganized thinking. See Report
For more information on schizophrenia, please visit the National Institute of Mental Health Web site.