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Risperdal Side Effects

risperdal pill bottleManufactured by Johnson & Johnson and Janssen Pharmaceuticals, Risperdal (risperidone) is a second generation atypical antipsychotic approved to treat schizophrenia, bipolar disorder, and irritability associated with autism. The medication first gained clearance in the United States in 2002, and one year later was approved for the short-term treatment of mania and mixed episodes linked to bipolar disorder.

The antipsychotic has also been used off-label to help treat patients suffering from depression, anxiety, Tourette’s syndrome and attention deficit hyperactivity disorder (ADHD).

Thousands of patients who have taken Risperdal and its generic equivalent argue that the drug has the potential to cause serious side effects, including gynecomastia, diabetes and permanent movement disorders, among other life-altering health conditions.

Common side effects of Risperdal

Like any prescription drug, Risperdal may have unintended side effects, some more serious than others.

Common Risperdal side effects may include:

  • Anxiety
  • Blurred vision
  • Headache
  • Dry mouth
  • Diarrhea
  • Feelings of aggression
  • Difficulty concentrating
  • Memory problems
  • Constipation
  • Urination increase or decrease
  • Skin rashes
  • Weight gain
  • Itching
  • Weakness in the limbs
  • Restlessness
  • Mask-like face
  • Trouble sleeping

Some patients have reported other, less common reactions to risperidone:

  • Dizziness
  • Shallow breathing
  • Deep thirst
  • Poor coordination
  • Back pain
  • Painful penile erections
  • Muscle cramps
  • Joint pain
  • Vomiting
  • Chills
  • Atrial fibrillation
  • Unusual bruising
  • Decreased appetite
  • Edema in limbs
  • Neuroleptic Malignant Syndrome
  • Lip puckering or smacking
  • Uncontrolled chewing movements
  • Sudden unusual facial expressions
  • Uncontrolled body movements, such as twisting of the neck, arms and legs
  • Worm-like tongue movements

Black box warning regarding elders with dementia

The FDA reserves black box warnings for products whose side effects may be life-threatening or result in death. In 2005, U.S. health regulators mandated a black box warning on all risperidone-containing drugs, cautioning they were not approved for use in older patients with dementia-related psychosis.

According to the FDA warning, “elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.” The move was based on clinical evidence that showed Risperdal treatment for dementia-related behaviors were linked to an increased risk for heart failure, stroke, cardiovascular injury and/or sudden death.

The FDA states that as early as March 2002, sales reps from Janssen Pharmaceuticals began to promote Risperdal to assisted living facilities and nursing homes as an easy and safe method to treat and effectively sedate agitated seniors suffering from dementia. These actions were the subject of an investigation by the U.S. Department of Justice, which ultimately accused Johnson & Johnson and Janssen of misbranding the drug for a purpose they knew posed severe health risks for the elderly.

Janssen had gotten several warnings from the FDA regarding its deceptive marketing strategies in regard to Risperdal benefits and uses. Ultimately, a whistle blower complaint filed with the FDA Office of Criminal Investigations sparked an investigation into the drug maker’s conduct.

Male breast growth caused by Risperdal

Risperdal functions by blocking dopamine receptors, which in turn regulate levels of prolactin, an essential sex hormone secreted by the pituitary gland. Because of this function, prolactin levels in users of Risperdal can quickly reach abnormal levels, resulting in hyperprolactinemia. This excess prolactin can cause male patients to develop breast tissue, otherwise known as gynecomastia.

An emotionally devastating side effect for many adolescent men, gynecomastia may affect both breasts and eventually require surgery (either liposuction or breast reduction). Though more of an aesthetic concern, this side effect has been tied to lasting psychological problems in many teen patients.

According to allegations leveled in one Risperdal lawsuit claiming the drug caused a 17-year old boy to develop breasts, “Johnson & Johnson knew about this side effect, did not warn about it and actually covered up evidence about it.” The plaintiff, a resident of Houston, Texas, had taken the drug to treat his autism at a time when the FDA had yet to approve the antipsychotic for use in children, contends the complaint.

Tardive dyskinesia & movement disorders

Tardive dyskinesia is a type of movement disorder that may result from exposure to neuroleptic medications like Risperdal.  The condition causes involuntary, uncontrolled movements that are often repeated in a quick series. Lip puckering, facial grimacing, and slow twisting movements of the torso, limbs and head are common. In some cases, the movements are accompanied by grunting sounds.

The effects of tardive dyskinesia are debilitating and often embarrassing to the point where many sufferers won’t leave the home. Unfortunately, a cure doesn’t exist for the condition or for tardive dystonia, which has also been associated with Risperidone exposure.

While the majority of antipsychotic medications carry a heightened risk of movement disorders, atypical drugs like Risperdal have been blamed for a disproportionate rate of tardive dyskinesia.

Increased diabetes risk

Some studies suggest a connection between Risperdal and the development of type 2 diabetes in children and adults. In certain patients, the drug can induce rapid weight gain, which predisposes patients to high blood sugar levels. One trial conducted by the Department of Veteran Affairs at the University of Illinois investigated Risperdal and diabetes risk among its patients. Researchers found that those age 54 and under who were taking Risperdal had the highest rate of diabetes.

Other studies indicate that the prevalence of diabetes is highest in patients with schizophrenia compared to the general population.

Patients who experience any adverse side effects while taking Risperdal should seek immediate medical attention.

Risperdal litigation

For some victims, litigation has been the most effective means to address economic losses and medical bills associated with Risperdal. In addition to civil actions filed by Risperdal patients suffering from movement disorders, dozens of young men who developed gynecomastia after taking the drug have also taken legal action. Litigation has been consolidated in the Philadelphia Court of Common Please, where J&J has already settled several claims.