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Risperdal bottleThe antipsychotic drug Risperdal and its cousin Invega were game-changers for Johnson & Johnson, Inc.’s subsidiary Janssen Pharmaceutical, Inc. At one point, Risperdal was prescribed so often that it was estimated to hold a 72-percent market share.

But Risperdal has been linked to serious side effects including gynecomastia and evidence shows that Janssen and J&J hid the risks from patients and doctors and engaged in misleading advertising.

What is Risperdal?

Risperdal is the brand name of risperdone, a powerful second-generation atypical antipsychotic. It is used to treat schizophrenia and bipolor disorder in adults and adolescents, as well as to treat behavioral symptoms exhibited by children with autism. The drug has also been prescribed for off-label conditions including attention deficit hyperactivity disorder (ADHD) and anxiety.

Invega, also manufactured by Janssen, is a metabolite alternative to Risperdal. A metabolite is a by-product of metabolism and it provides an extended release. Invega purportedly has been tied to the same side effects as Risperdal like uncontrollable muscle movements and dangerous metabolic changes.

State attorneys general around the country have pursued claims of damages to the states based on allegations of false advertising of Risperdal and consumer protection violations. Over 400 private Risperdal lawsuits have also been filed against the drug maker over claims that the drug may cause diabetes and male breast growth.

When the FDA initially approved Risperdal in 1993, the approval was for the treatment of schizophrenia and bipolar disorder. In 2006, the FDA added approval to treat irritability in autistic children. The approvals, however, came with a warning; in 2005 a black box warning was added to alert consumers and physicians that the drug is not to be used in conditions related to dementia because heart failure, pneumonia, or death could occur.

Risperdal and gynecomastia

One of the most distressing side effects that over 1,000 Risperdal users have reported is gynecomastia – abnormal breast growth in boys and men. Gynecomastia can lead to emotional distress and sometimes requires surgery to correct.

According to the testimony of one former US Food & Drug Administration leader, Risperdal “probably or very likely” caused as many as 3.8% of the boys who took it to grow breasts. A national study of the records of one million men showed that older men who took Invega were 69% more likely to develop the condition. In that study, over 8,000 men were identified with the condition.

Janssen is under fire for failing to warn about the risk of gynecomastia, which is at the center of nearly 1,400 cases pending in the Risperdal mass tort in Philadelphia. There were three bellwether cases scheduled that took place in late 2014 and early 2015. In the first of the Risperdal trials, a jury returned a $2.5 million verdict in favor of the plaintiff. In the second trial, Janssen was once again found negligent in failing to warn about the risk of gynecomastia but the jury did not award damages because it did not find a causal effect with the plaintiff’s symptoms. Janssen settled the third scheduled case even before presenting its opening argument.

Other reported Risperdal side effects

Atypical, or second-generation, antipsychotics like Risperdal and Invega typically do not have the same types of side effects that first-generation antipsychotics had. But because they work by changing the body’s chemistry, Risperdal and Invega have been associated with an array of unwanted, and sometimes very serious, effects including:

  • Sexual dysfunction – Some users have experienced sexual side effects including decreased libido.
  • Movement disorders including tardive dyskinesia and tardive akathisia.
  • Cardiovascular problems – Complications can include stroke, high blood pressure, heart palpitations, heart attack, and even death.
  • Neuroleptic malignant syndrome – Risperdal has been linked to this neurological disorder, causing symptoms like rigid muscles, changes in blood pressure, autonomic instability, paranoia, and delirium
  • Sensitivity to heat and cold – Risperdal users can become overheated or dehydrated while taking the drug.
  • Dizziness and impaired thinking – Risperdal can slow response time, making driving and operating machinery dangerous.
  • High blood sugar – Risperdal use has been associated with an increased risk of diabetes.

Even though Risperdal has been widely marketed, the manufacturer has warned that it is not safe for many patients, such as those with conditions including dementia; kidney, heart, or liver disease; high cholesterol; history of heart attack, stroke, low white blood cell count, or breast cancer; Parkinson’s disease, diabetes, or epilepsy.

Risperdal litigation and allegations

To protect their citizens, states across the country have brought lawsuits against Janssen. These state cases allege violations of:

  • Consumer protection laws
  • Anti-fraud statutes

These state suits have resulted in hundreds of millions of dollars that J&J and Janssen have paid to settle the states’ claims, and a $2.2 billion fine levied by the federal and state governments.

Separate from and in addition to the state cases, individuals who took Risperdal have the right to seek compensation for their injuries. Though there are already over 1,000 Risperdal gynecomastia cases pending in Philadelphia court, research shows that there are countless other victims who may have a viable claim for damages.

  1. The Legal Intelligencer, Risperdal Accords Don’t Mean Swift End to Litigation,

  2. Medscape, Antipsychotic May Boost Gynecomastia Risk,

  3., Risperdal,

  4. The Philadelphia Courts, Risperdal MDL Case List,

  5. The Augusta Chronicle, South Carolina justices order company to pay state $136 million over deceptive marketing,