Rispderal Induced Gynecomastia Sparks Litigation

Risperdal received FDA approval in 1993. It is an atypical antipsychotic medication used to treat schizophrenia and symptoms of bipolar disorder, in addition to symptoms of irritability in autistic children. Some doctors have also prescribed it to treat obsessive-compulsive disorder, stuttering, Tourettes syndrome, and severe dementia. Doctors and scientists aren’t sure exactly how Risperdal works, but assume it impacts the serotonin and dopamine neurotransmitters in the brain.

By 1996, prescriptions for the drug had exceeded one million, but has since been associated with some serious side effects. Risperdal and gynecomastia have been linked, in addition to a number of other serious side effects. More than 420 lawsuits had been filed in courts throughout the country by 2012, with plaintiffs and their Risperdal lawyer claiming the manufacturer, Ortho-McNeil-Janssen, a Johnson & Johnson subsidiary, failed to include adequate warnings on product labels regarding health risks.

Risperdal and gynecomastia

Risperdal has been associated with many harmful side effects. Minor side effects include sensitivity to temperature, impaired thinking, dizziness, hyperactivity, sudden involuntary muscle movements, abdominal pain, fatigue, fever, and nausea. Some of the more harmful side effects include gynecomastia, diabetes, neuroleptic malignant syndrome, sexual dysfunction, cardiovascular problems, stroke, and even death.

FDA warnings

The FDA issued a warning about Risperdal in April 2005. The agency required a black box warning on all risperidone product labels, warning patients and physicians that they use of the drug in elderly patients with dementia was associated with an increased risk of mortality. In October 2006, the FDA approved Risperdal for the treatment of irritability associated with autism in children and adolescents.

Another FDA approval was issued in August 2007 for the use of risperidone for children ages 13-17 with schizophrenia, and for children ages 10-17 with bipolar disorder. In November 2008 at an FDA meeting, doctors raised concerns about the drug’s side effects in children, including gynecomastia. The agency chose not to strengthen the warnings on the drug.

Many patients seek counsel from a Risperdal lawyer

Patients began to consult with a lawyer and file Risperdal lawsuits against the manufacturer in 2008, claiming the defendant failed to provide proper warnings of the risks associated with the drugs.

Examples of Risperdal lawsuits include:

• 2008 Risperdal gynecomastia lawsuit: The lawyer representing six teenage boys who allegedly suffered gynecomastia after taking the drug told the Wall Street Journal that the drug can stimulate the production of “prolactin,” a hormone involved in lactation.
• August 2012 fraud settlement: Johnson & Johnson reached a $181 million consumer fraud settlement with 36 states and the District of Columbia. State and federal authorities accused the company of promoting the drug for off-label uses it was not approved to treat.
• September 2012 Risperdal lawsuit: A pre-trial settlement was reached in a Pennsylvania Risperdal lawsuit, where the male plaintiff claimed to have suffered psychological trauma after taking the drug for five years, from 1999 to 2004.
• October 2012 Risperdal settlements: The defendant agreed to five settlements concerning Risperdal and gynecomastia in Philadelphia.