Risperdal, an atypical antipsychotic linked to severe male breast development, has been illegally promoted by Johnson & Johnson for off-label uses. Risperdal side effects have injured scores of young men with ADHD, as well as older men suffering from dementia.

Risperdal can cause breast growth, movement disorders, and cardiac irregularities.Studies linked Risperdal to gynecomastia in older men and boys.Investigations uncovered that Johnson & Johnson intentionally promoted Risperdal for unapproved uses.Men and boys affected by Risperdal can access resources to help manage side effects.

 

The Truth

Risperdal Antipsychotic Linked To Breast Growth In Children And Adolescents

Risperdal, also known as Risperidone, treats a variety of mental mood disorders including schizophrenia, manic depression, and irritability linked to autism.

Also known as Risperidone, Risperdal is a member of the atypical antipsychotic drug class. The second generation drug comes as a tablet, liquid or injection.

Johnson & Johnson did not officially promote Risperdal for off-label use but covertly encouraged doctors to prescribe the drug to children and adolescents for conditions like attention deficit hyperactive disorder (ADHD) and anxiety.

Risperdal has been linked to a number of side effects, including breast growth, movement disorders, cardiac issues, and even death.

Studies + Science

Doctors prescribe Risperdal to both adults and children. The Archives of General Psychiatry published a study in 2012 that showed Risperdal was prescribed to children 20 percent more frequently than adults.

How Risperdal Works

Risperdal is considered an atypical antipsychotic because it acts on the brain’s dopamine and serotonin, whereas general antipsychotics only alter dopamine levels. The antidepressant Abilify is also an atypical antipsychotic.

Common Risperdal side effects include:

  • Jerking of the head, neck, arms or eyes
  • Dizziness
  • Fatigue
  • Fever
  • Nausea
Less common Risperdal side effects include:

  • Agitation and aggressive behavior
  • Anxiety
  • Difficulty speaking and concentrating
  • Loss of balance and memory problems
  • Problems with urination
  • Skin rash
  • Difficulty sleeping
  • Stiffness or weakness of the arms and legs

Risperdal also impacts the body’s hormone receptors, leading to higher levels of the hormone prolactin. Many scientists believe that Risperdal’s effect on prolactin causes a severe side effect known as gynecomastia.

Risperdal Side Effects: Male Breast Growth

Gynecomastia is a condition characterized by swollen male breast tissue. The condition, which affects males through a hormone imbalance, causes a mass to grow under the nipple. The mass may be tender and cause fluid discharge.

Studies conducted by Johnson & Johnson discovered that 5 percent of young boys experienced breast growth—the most common of Risperdal side effects.

Many people suffering from gynecomastia will elect to have their breasts removed. Depending on the medical facility, Gynecoma estimates the cost of revision surgery ranges from $6,000 to $8,500.

Procedure / ServiceApproximate cost
Surgeon Fee$ 4000 – $ 4500
Anesthesia$ 1500 – $ 2000
Lab Tests$ 500 – $ 1000
Post-surgery Compression Shirts / Vest$ 100- $ 500

“Almost all health insurance companies consider gynecomastia surgery as cosmetic unless an underlying medical condition like a tumor that warrants surgery is identified,” according to Gynecoma. “So if you are doing gynecomastia surgery for purely psychological or social well-being, your chances of getting your gynecomastia surgery cost covered by your health provider are low.”

Risperdal Side Effects: Movement Disorders

Risperdal has also been linked to multiple painful and debilitating movement disorders, including:

  • Tardive dyskinesia
  • Extrapyramidal symptoms (EPS)
  • Dystonia

Regulation Recap

Risperdal was introduced by Johnson & Johnson in 1994 as an effective treatment for schizophrenia. In 1993, the FDA extended Risperdal’s uses to treat schizophrenia in adults. The agency’s approval for children and adolescents didn’t come until late 2006.

Risperdal was recalled twice, though not because of its dangerous side effects. In 2011, Risperdal was recalled because of chemical contamination. The drug was recalled again in 2013 because of a mold problem.

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. RISPERDAL® is not approved for use in patients with dementia-related psychosis. (5.1)

J&J’s Marketing Scheme

A recent examination has revealed that Risperdal was marketed for off-label use by Johnson & Johnson after the company allegedly ignored its potential for adverse reactions in young boys and elderly patients who were prescribed the drug to treat unapproved conditions.

That’s because the corporation didn’t want to limit the drug to treating just one group of patients.

Hoping to make a real profit by expanding the drug to other conditions, the company began to market Risperdal to seniors with dementia and children with autism.

Johnson & Johnson enrolled the drug in corporate welfare programs, paid doctors for endorsements and urged the state of Texas to use Risperdal instead of comparable generics. The company made $3,000 a year for each Medicaid patient through this tactic alone, according to The Huffington Post.

The drug manufacturer made a profit-share agreement with a pharmaceutical provider for nursing homes called Omnicare, targeting elderly patients in their own environment. Going further, J&J created ElderCare to directly push seniors to use the drug despite the rising number of deaths. Even more frustrating is the fact that the FDA did nothing to combat this unlawful marketing scheme.

J&J was simultaneously setting its sights on children in an outrageous effort to maximize profits. The company started employing pediatricians to market the drug for unintended uses. According to the New York Times, “more than one-fifth of Risperdal was going to children and adolescents” by the year 2000.

Johnson & Johnson continued these efforts and disregarded the studies, one of which found that more than 5 percent of young boys grew breasts from taking the drug. These marketing campaigns went hand-in-hand with the alleged cover-up of Risperdal’s side effects.

Off-Label Litigation

Recent lawsuits have been examining the claim that Johnson & Johnson reportedly knew Risperdal could lead to strokes in older patients and cause young boys to grow female breasts. Ignoring the fact that the breast-growth condition called gynecomastia would irrevocably impact their lives is inconceivable.

Although Johnson & Johnson was ordered to pay $2 billion in penalties and settlements, the company still took home an estimated $30 billion from worldwide sales. To make matters worse, the person in charge of off-label marketing was promoted to CEO. Alex Gorsky made $25 million last year while an unknown number of patients suffered.

The Next Steps

The rise in lawsuits has prompted the FDA to stand up against Risperdal. FDA Commissioner David Kessler testified that the company did not provide sufficient warning to doctors and the FDA after conducting a study that the drug produced higher levels of the hormone prolactin, which can lead to gynecomastia.

“If somebody is sending a sales rep into a doctor’s office, into a pediatric neurologist’s office, and doing it multiple times, you have an obligation to provide adequate direction,” Kessler said. “Tell the good. Tell the bad.”

It’s your right to know about each and every side effect. It’s your right to make a decision for your health, and the health of your family.

If you or a family member developed life-changing side effects from Risperdal, connect with an advocate to learn more about how to move forward.