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Risperdal and Antipsychotic Off-Label Use

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Our law firm is concerned with the prevalence of antipsychotic off-label use, especially Risperdal. We are currently filing lawsuits on behalf of individuals who allegedly developed gynecomastia (abnormal breast growth) and other serious complications secondary to Risperdal use.

Risperdal, or Risperidone, is an aytipcal antipsychotic manufactured by Johnson & Johnson subsidiary, Janssen. The drug was initially approved by the Food and Drug Administration (FDA) for use in adults with schizophrenia and schizoaffective disorders. Off-label marketing of the drug promoted physicians to use Risperdal in children and teenagers with other behavioral and mental disorders. Unfortunately, antipsychotic off-label use, such as with Risperdal, is not uncommon.

According to Prescribing of antipsychotics in UK primary care: a cohort study, a significant proportion of individuals prescribed antipsychotics have no diagnosis of psychotic or bipolar disorders. Less than half of the individuals prescribed antipsychotics actually had a diagnosis  of psychosis or bipolar disorder. These results stem from the study involving individuals in the UK prescribed antipsychotics between 2007 and 2011.

The study indicated approximately half of the prescriptions for first-generation and second-generation antipsychotics were issued to individuals with no record of Serious Mental Illness (SMI)- e.g. schizophrenia, schizoaffective disorder, and bipolar affective disorder. Mental health conditions for which antipsychotics might be prescribed off-label use include anxiety, depression, sleep disorders, and attention deficit disorders, all non-SMI disorders. Furthermore, the median daily doses and duration of treatment with antipsychotics in people with non-SMI were substantial and similar to people with SMI.

Prescribing antipsychotics requires caution given their association with a myriad of adverse side effects. For instance, some side effects of Risperdal, in addition to gynecomastia, include Galactorrhea (i.e. breasts produce milk or discharge), severe weight  gain, sexual dysfunction, increased suicide risk, and hyperglycemia (i.e. high blood sugar). These side effects led to a significant number of lawsuits with allegations against Johnson & Johnson. The number of victims increases with time. There are multiple lawsuits alleging severe personal damages filed against Johnson & Johnson.


If you, or a loved one, were diagnosed with gynecomastia secondary to Risperdal use, contact attorney Stuart Talley for a free case consultation. Fill out the contact form on this page, or call toll free at (888) 997-5170. 

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