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Risperdal (Risperidone) - Summary

 
 



Increased Mortality in Elderly Patients with Dementia–Related Psychosis

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Analyses of seventeen placebo controlled trials (modal duration of 10 weeks) in these patients revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients. Over the course of a typical 10 week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. RISPERDAL® (risperidone) is not approved for the treatment of patients with Dementia-Related Psychosis.

 

RISPERDAL SUMMARY

RISPERDAL®
(risperidone)
TABLETS/ORAL SOLUTION
RISPERDAL® M-TAB®
(risperidone)
ORALLY DISINTEGRATING TABLETS

RISPERDAL® (risperidone) is a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl] -6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one.

RISPERDAL® (risperidone) is indicated for the following:

SCHIZOPHRENIA

RISPERDAL® (risperidone) is indicated for the treatment of schizophrenia.

The efficacy of RISPERDAL® in schizophrenia was established in short-term (6- to 8-weeks) controlled trials of schizophrenic inpatients (see CLINICAL PHARMACOLOGY).

The efficacy of RISPERDAL® in delaying relapse was demonstrated in schizophrenic patients who had been clinically stable for at least 4 weeks before initiation of treatment with RISPERDAL® or an active comparator and who were then observed for relapse during a period of 1 to 2 years (see CLINICAL PHARMACOLOGY - Clinical Trials). Nevertheless, the physician who elects to use RISPERDAL® for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).

BIPOLAR MANIA

Monotherapy

RISPERDAL® is indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder.

The efficacy of RISPERDAL® was established in two placebo-controlled trials (3-week) with patients meeting DSM-IV criteria for Bipolar I Disorder who currently displayed an acute manic or mixed episode with or without psychotic features (see CLINICAL PHARMACOLOGY).

Combination Therapy

The combination of RISPERDAL® with lithium or valproate is indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder.

The efficacy of RISPERDAL® in combination with lithium or valproate was established in one placebo-controlled (3-week) trial with patients meeting DSM-IV criteria for Bipolar I Disorder who currently displayed an acute manic or mixed episode with or without psychotic features (see CLINICAL PHARMACOLOGY).

The effectiveness of RISPERDAL® for longer-term use, that is, for more than 3 weeks of treatment of an acute episode, and for prophylactic use in mania, has not been systematically evaluated in controlled clinical trials. Therefore, physicians who elect to use RISPERDAL® for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).


See all Risperdal indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Risperdal (Risperidone)

Janssen Pharmaceuticals, Inc. to plead guilty and pay over $1.6 billion to resolve allegations of misbranding and filing false claims for Risperdal
Source: Litigation / Medical Malpractice News From Medical News Today [2013.11.06]
On behalf of the U.S. Food and Drug Administration, the U.S. Department of Justice on November 4th, 2013 announced a guilty plea agreement with Janssen Pharmaceuticals, Inc., (JPI) of Titusville, N.J.

more news >>

Published Studies Related to Risperdal (Risperidone)

Double-blind placebo-controlled randomized efficacy and safety trial of add-on treatment of dimebon plus risperidone in schizophrenic patients during transition from acute psychotic episode to remission. [2012]
CONCLUSION: Dimebon as add-on therapy to antipsychotic treatment in the period of

Cost and cost-effectiveness in a randomized trial of long-acting risperidone for schizophrenia. [2012]
CONCLUSIONS: Patients with unstable schizophrenia were randomized in a practical

Early treatment with risperidone for subsyndromal delirium after on-pump cardiac surgery in the elderly: a randomized trial. [2012]
clinical delirium in elderly patients who underwent on-pump cardiac surgery... CONCLUSION: Administration of risperidone to elderly patients who experienced

A double-blind placebo controlled trial of Ginkgo biloba added to risperidone in patients with autistic disorders. [2012]
Ginkgo biloba has been reported to affect the neurotransmitter system and to have antioxidant properties that could impact the pathogenesis of Autism Spectrum Disorder. Based on these studies, we decided to assess the effectiveness of Ginkgo biloba extract (Ginko T.D., Tolidaru, Iran) as an adjunctive agent to risperidone in the treatment of autism.

Therapeutic effects of cerebrolysin added to risperidone in patients with schizophrenia dominated by negative symptoms. [2012]
negative symptoms... CONCLUSION: Cerebrolysin added to risperidone did not augment the efficacy of

more studies >>

Clinical Trials Related to Risperdal (Risperidone)

Risperdal Consta for Bipolar Disorder [Active, not recruiting]
We are recruiting 50 consenting adult subjects with DSM-IV TR diagnoses of bipolar disorder who are about to initiate or switch their current antipsychotic agent. Patients are titrated and cross-tapered during a 3 month titration and stabilization phase. Presently 4 of the 11 subjects enrolled have transitioned successfully and are in Phase III of the study. After transitioning into the next phase, they will be followed for an additional 12 months. Clinical outcomes such as study drop out, adverse events, worsening of symptoms, crisis interventions, need for additional medication, hospitalizations etc. will be evaluated from months 3 to 15 (visits 8-20). The time to clinical events will be used to evaluate if the long acting injectable form of risperidone has an advantage over the oral second generation antipsychotic agents in terms of treatment continuity and clinical stability.

Schizophrenia Risperidone vs Olanzapine Study HGMN [Completed]
Summary of Study Design This is a randomized, double-blind, flexible-dosed, parallel study exploring the relationship between early response to an antipsychotic medication and subsequent improvement in psychopathology using the atypical antipsychotic risperidone, and determining if patients who do not show an early response to risperidone can achieve an adequate improvement in clinical status following 10 weeks of treatment with olanzapine.

Evaluation of the Usefulness to Doctors of the RisperdalŽ ConstaŽ Treatment Guidebook Over a Three-Month Period During Which Adult Patients With Schizophrenia or Schizoaffective Disorder Are Switching From Daily Doses or Risperidone Tablets to Long-Acting Risperidone by Injection [Completed]
The purpose of this study is to assess the usefulness of the RisperdalŽ ConstaŽ Treatment Guidebook in helping the doctor switch the adult patient from taking risperidone tablets daily by mouth to taking long-acting risperidone by injection. The study will also evaluate the effectiveness and safety of long-acting risperidone and its effect on patient satisfaction.

Oral Versus Injectable Risperidone for Treating First-Episode Schizophrenia [Recruiting]
This study will determine the effectiveness of oral risperidone versus long-acting injectable risperidone in treating people with first-episode schizophrenia.

High Dose Risperidone Consta for Patients With Schizophrenia With Poor Response to Risperidone [Recruiting]
The purpose of this study is to look at two doses of long-acting injectable risperidone (Risperdal Consta). The study will use a usual dose of Risperdal Consta (50 mg given every two weeks) or a higher dose (75 mg-100 mg given every two weeks) to see which one is better at improving symptoms of schizophrenia or schizoaffective disorder.

more trials >>

Reports of Suspected Risperdal (Risperidone) Side Effects

Weight Increased (126)Self Injurious Behaviour (111)Somnolence (89)Suicide Attempt (85)Drug Ineffective (62)Aggression (55)Multiple Drug Overdose Intentional (53)Pneumonia (53)Type 2 Diabetes Mellitus (53)Insomnia (52)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 8 ratings/reviews, Risperdal has an overall score of 3. The effectiveness score is 4.75 and the side effect score is 4. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Risperdal review by 30 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   Anxiety
Dosage & duration:   1 mg a day and as needed taken every day for the period of for 3+ years-currently, various doses
Other conditions:   bipolar disorder, add, hypothyroid
Other drugs taken:   Lamictal, Neurontin, Strattera, Levothyroid, Klonopin
  
Reported Results
Benefits:   In the case of a panic attack, this would soothe the anxiety and calm me down-a numbing sensation--a highly effective anti-psychotic in several situations--kept a low-level feeling of calmness and barrier to anxiety/stress
Side effects:   Unfortunately, weight gain was a marked side effect, and led me to take a lower dose--also in high doses, I almost felt like a zombie--totally numb and emotionless--a disturbing concept.
Comments:   Prescribed by my psychiatrist to use in various doses over several years of use to use for anxiety and panic, and in conjunction with Klonopin as an effective measure to reduce a mixed/manic episode of bipolar disorder in an acute situation, and also at a low-level dose every day to reduce the chance of episodes from occuring. Good tool in anger management as well.

 

Risperdal review by 28 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Extremely Severe Side Effects
  
Treatment Info
Condition / reason:   phycotic episode
Dosage & duration:   I was to druged to remember (dosage frequency: daily) for the period of 10 months
Other conditions:   Bi-polar
Other drugs taken:   anti-depressent
  
Reported Results
Benefits:   The benefit to the drug was that yes it did work i was crazy (locked up in mental ward) and then after usage became normal (not crazy) again.However my treatment plan was not good. plan
Side effects:   The side affects were realy they inclued; Leg jerking/kicking in bed at night sudden stiffning of legs ( unable to walk) Eyes unable to close eyes rolling back into head unable to make it to the toilet on time sleeping a lot gained 12kg unable to think , no thoughts in head unable to concentrate
Comments:   The treatment plan was realy bad. Although i had gone from crazy back to normal again over an 8 day period i was then made to take the drug for another 9 and a half months there after. This drug should be used as needed e.g taken to stop being crazy, and then stopped once patient has returned to normal state NOT any longer! I was basicly druged up to the eye balls an lost almost a year of my life.

 

Risperdal review by 25 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Extremely Severe Side Effects
  
Treatment Info
Condition / reason:   schizophrenia
Dosage & duration:   3.5 (dosage frequency: twice) for the period of enough to ruin me
Other conditions:   Depression
Other drugs taken:   Lexapro 10 mg
  
Reported Results
Benefits:   There were no known benefits. I truly believed that the doctor that prescribed me this stupid medication should rot in hell. There are too many side effects, especially long term ones. The worst part is, they did not even tell me how and why their diagnosis was accurate. they just prescribe drugs left and right as if they had no conscience or they are evil people just out for the money.
Side effects:   memory loss, heart diseasse, increased panick attacks, curbed thinking, loss of sex drive, increased paranoia, increased suicidal thoughts, increase in depression, anxiety. Decreased mental capacities.
Comments:   I was put on 3.5 mg of this damned drug.

See all Risperdal reviews / ratings >>

Page last updated: 2013-11-06

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