Risperdal (risperidone) is an atypical (with different chemical reactions in the brain than older antipsychotics) antipsychotic used to treat adult schizophrenia, adolescent schizophrenia, schizoaffective disorder, the mixed and manic states associated with bipolar disorder (alone or in combination with valproate or lithium), and irritability in children with autism.
Risperdal has also been used off-label [use not approved by the US Food and Drug Administration] for the treatment of obsessive-compulsive disorder, severe, treatment-resistant depression, other anxiety disorders, Tourette syndrome, eating disorders, and disruptive behavior disorders in children, among others.
Risperdal carries a black box warning asserting that it is not approved for use in elderly patients with dementia-related psychosis because of an increased risk of death. Major warnings regarding the use of Risperdal include:
- a risk of causing Neuroleptic Malignant Syndrome
- a potential to cause tardive dyskinesia
- the dosage should be reduced for elderly patients and patients with liver or kidney disease
- patients with diabetes or risk factors for diabetes should have regular blood glucose monitoring, all others should be monitored for symptoms of hyperglycemia
- patients should not breast-feed and should notify their doctor if pregnant or planning to become pregnant
- combining with blood pressure medicine can result in blood pressure that is too low
Risperdal is increasingly being associated with gynecomastia in teenage boys who have been prescribed the drug. Thousands of lawsuits have been filed against Johnson & Johnson, the makers of the drug, based on the failure to warn that gynecomastia is a side effect of Risperdal.
In July 2009, the FDA announced the approval of labeling changes to the Precautions section for Risperdal, including:
- There have been reported events of leukopenia/neutropenia and agranulocytosis in clinical trials and/or postmarketing experience.
- Possible risk factors for leukopenia/neutropenia may include pre-existing low white blood cell count (WBC) and history of drug-induced leukopenia/neutropenia. Patients with these predispositions should have their complete blood count monitored frequently during the first few months of therapy. Discontinuation of Risperdal should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors.
- Patients with clinically significant neutropenia should be carefully monitored for fever or other signs or symptoms of infection and treated promptly if such signs or symptoms occur. Patients with severe neutropenia should discontinue Risperdal and have their WBC monitored until recovery.
Emergency medical help should be sought if any of the following side effects associated with the use of Risperdal develop:
- allergic reaction including hives, difficulty breathing, swelling of the face, throat, lips, or tongue
- stiff muscles
- fast or uneven heartbeats
- restless muscle movements in eyes, tongue, neck, or jaw
- uncontrolled shaking (tremor)
- flu symptoms, including fever, chills, or body aches
- sores or white patches on the lips or inside the mouth
- trouble swallowing
- feeling light-headed
Less serious side effects of Risperdal may include:
- mild tremor, restlessness, or drowsiness
- dreaming more than usual
- blurred vision
- dry mouth
- problems with urination
- weight gain
- decreased sex drive
- difficulty having an orgasm
There are numerous additional precautions, contraindications, dangerous interactions, and potential side effects associated with the use of Risperdal. Risperdal is a powerful antipsychotic and should be used with care.
If you or a loved one has suffered or is suffering side effects associated with the use of Risperdal or risperidone, you may be entitled to compensation. Browse our directory of attorneys to find a Risperdal injury lawyer near you.