Boys and young men who take the antipsychotic drug Risperdal (generic: risperidone) may have an increased risk of developing gynecomastia, an embarrassing and emotionally damaging medical condition characterized by abnormal breast tissue enlargement.
Update: Settlement Reached in Risperdal Gynecomastia Lawsuit
January 11, 2017 – Janssen Pharmaceuticals has settled another products liability lawsuit alleging gynecomastia from Risperdal days before what would have been the seventh such case to go to trial. Plaintiff Zachary Sabol filed his complaint in the Philadelphia Court of Common Pleas in April 2013, alleging that he developed boy boobs after taking Risperdal for about a decade.
What is Risperdal?
Risperdal is an atypical antipsychotic medication used to treat schizophrenia, bipolar disorder and irritability caused by autistic spectrum disorders. The drug works by rebalancing the neurotransmitters dopamine and serotonin, which improves thinking, mood and behavior. Risperdal is made by Janssen Pharmaceutica (a Johnson & Johnson company) and was approved by the U.S. Food & Drug Administration (FDA) in 1993.
Risperdal and Gynecomastia
One of the most serious and widely reported side effects associated with atypical antipsychotics like Risperdal is gynecomastia, or the development of abnormally large breasts in boys and young men. Males with the condition not only accumulate fat in their chest tissues, but they also develop excess glandular tissue. This leaves men with breasts that resemble those of women.
The degree of enlargement can vary significantly from one patient to the next, and while gynecomastia typically occurs in both breasts, in some cases it can affect just one. When the condition develops in both breasts, each can be affected differently. One breast may grow larger than the other, leaving the patient with an even more embarrassing appearance. Some men with gynecomastia may even produce breast milk.
How Antipsychotics Cause Male Breast Growth
Risperdal’s dopamine-blocking mechanism of action increases levels of prolactin, a hormone released by the pituitary gland. In women, prolactin stimulates breast development and production of breast milk. When prolactin levels become elevated in men, it can lead to gynecomastia and abnormal lactation (galactorrhea). In extreme cases, some male Risperdal users have developed large, D-cup breasts.
A study published in the August 2015 online edition of the Journal of Child and Adolescent Psychopharmacology found that Risperdal users were 4x more likely to develop gynecomastia compared to patients who did not take the medication, and that children and adolescents users were 5x more likely to have the condition compared to non-users. “Risperidone is associated with an increase with the risk of gynecomastia in adolescent and young adult males,” the researchers concluded.
Effects of Gynecomastia
In most cases, gynecomastia is not a threat to physical health. However, the condition often causes significant emotional and psychological damage to the males who develop it. In April 2013, a study published in Plastic and Reconstructive Surgery reported on a series of psychological tests performed on 47 adolescent boys with gynecomastia and a group of boys with no breast enlargement.
The gynecomastia group scored lower for general health, social functioning, self-esteem, mental health and eating behaviors. These effects were similar in all subjects with male breast enlargement, suggesting that merely having the condition, no matter how severely, causes significant psychological damage.
Patients who require surgery to resolve gynecomastia may experience physical pain and trauma. Complications from breast reduction surgery may include:
- Prominent scarring
- Blood clots
- Anesthesia reactions
- Breast shape irregularities
- Nerve damage
According to the Mayo Clinic, most cases of gynecomastia resolve over time without treatment. However, if the condition is caused by an underlying factor, it may need to be treated. If Risperdal is determined to be the likely cause of a patient’s gynecomastia, their doctor may recommend discontinuing treatment if favor of another drug with fewer side effects. However, you should never quit or change medications without talking to your doctor first.
Risperdal Illegally Marketed to Children
The U.S. Department of Justice (DOJ) has accused J&J of illegally marketing Risperdal to children before it was approved for use in pediatric patients. At a trial in Pennsylvania, a J&J sales manager claimed the company trained its sales force to promote Risperdal to pediatricians as early as 2003. J&J moved forward with this campaign despite the fact that the drug lacked approval for any use in children at the time.
Additionally, the company has been accused of paying kickbacks to doctors to speak favorably about Risperdal, sponsoring golf outings, and offering other lucrative incentives to encourage physicians to prescribe the medication “off-label” to pediatric patients.
J&J Pays $2.2 Billion in Risperdal Settlement
Illegal marketing allegations eventually landed J&J and Janssen in hot water with consumer protection regulators in at least 36 states, and in May 2012, Kentucky Attorney General Jack Conway filed a lawsuit against the companies for concealing information about dangerous Risperdal side effects including type 2 diabetes, weight gain, stroke and gynecomastia.
“Despite knowledge to the contrary, J&J represented to doctors that Risperdal had a safety profile unmatched by any other antipsychotic drug,” Conway said. The company even directed salespeople to say that “Risperdal had a zero percent rate of diabetes in trials, contrary to its own study result.”
On Nov. 4, 2013, the Justice Department announced that J&J agreed to pay $2.2 billion in criminal and civil fines to settle accusations that it illegally marketed Risperdal to older adults, children and patients with developmental disabilities. In a news conference announcing the settlement, U.S. Attorney General Eric Holder said J&J and Janssen “recklessly put at risk the health of some of the most vulnerable members of our society — including young children, the elderly and the disabled.” The agreement was the 3rd largest pharmaceutical settlement in U.S. history, as well as the largest in a series of lawsuits involving the marketing of antipsychotic and anti-seizure medications to older dementia patients, according to The New York Times.
Risperdal Side Effects
Serious side effects of Risperdal include:
- Production of prolactin
- Pituitary tumors
- Tardive Dyskinesia
- Neuroleptic Malignant Syndrome (NMS)
- Increased risk of sudden death from heart attack
- Diabetes, hyperglycemia and other blood sugar side effects
- Weight gain, potentially rapid and extreme
- Suicide, suicidal thoughts
- Bone loss
- Increased mortality in the elderly with dementia and related psychosis
- And more
Has a Class Action Been Filed?
In April 2012, J&J was ordered to pay $1.1 billion to resolve allegations by the state of Arkansas that it failed to adequately warn of the health risks associated with Risperdal. The verdict marked the company’s 3rd straight loss in Risperdal lawsuits filed on the state level regarding marketing of the drug. Arkansas alleged that J&J had concealed known side effects of Risperdal, and mislead the state’s Medicare program, causing it to overpay for prescriptions of the drug. Previous Risperdal class action lawsuits filed in Louisiana and South Carolina have resulted in fines of $258 million and $327 million, respectively, as well as a $158 million settlement in Texas.
Risperdal lawsuits allege that J&J and Janssen:
- Illegally marketed Risperdal off-label to children with autism and other psychiatric disorders without FDA approval from 1993 to 2004.
- Hid information about the drug’s potential health risks.
- Misrepresented the benefits of Risperdal for use in children.
- Created sales goals and incentives to motivate its sales force to promote off-label uses to elderly dementia patients and children with psychiatric disorders.
- Paid kickbacks to America’s largest nursing home pharmacy for promoting Risperdal to doctors treating nursing home patients.
- Paying doctors to learn about Risperdal’s unapproved uses as part of a “sham” consulting program.
- Awarding doctors with consulting agreements, speaker fees, retreats at luxury hotels and other incentives to support unapproved uses and to increase Risperdal prescriptions.
1993 – Approved by the U.S. Food & Drug Administration
Risperdal approved as an atypical antipsychotic by the U.S. Food & Drug Administration (FDA) for the treatment of manic or mixed delusional episodes such as schizophrenia. It soon becomes one of the best-selling and widely-prescribed prescription medications in America.
1996 – Risperdal prescriptions top 1 million
2001 – Miami Herald Publishes Stories
The Miami Herald publishes a series of stories about the common use of Risperdal among children in state care. Child-welfare advocates said the drug routinely was being used by foster care providers as a chemical restraint on children with “unruly” behavior
2002 – Janssen issues warning letter
Janssen Pharmaceuticals issues a warning letter to Health Canada regarding the risks associated with prescribing Risperdal to elderly patients. FDA is not issued this warning until the following year. Also in 2002, Risperdal is linked to at least 37 cases of stroke-like events including 16 deaths.
2003 – Risperdal is approved in the U.S. to treat bipolar disorder
2004 – “Off-label” prescribing becomes widespread
“Off-label” prescribing of Risperdal becomes widespread. Unapproved uses include Alzheimer’s, autism spectrum disorders (ASDs) and attention-deficit/hyperactivity disorder (ADHD).
2005 – Risperdal becomes most prescribed antipsychotic in U.S.
Risperdal becomes the most prescribed antipsychotic medication in the U.S., with sales topping $2 billion, despite a “black box” warning being added to the drug’s label regarding use on the elderly population.
2006 – Duke University Study
A study conducted by researchers at Duke University identifies a link between Risperdal and gynecomastia, or the abnormal growth of breast tissue in boys and young men. The researchers also determined that the gynecomastia risk associated with Risperdal is greater than with other antipsychotic medications. The same study found that some girls and young adult females who took Risperdal began lactating before puberty.
2007 – FDA approves Risperdal for the treatment of schizophrenia in teenagers
2008 – Wall Street Journal report published
A report published in the Wall Street Journal states that Risperdal may increase male production of prolactin, a hormone that stimulates milk production. The report surfaced after a lawyer representing boys who suffered from gynecomastia filed a lawsuit against Johnson & Johnson.
2010 – Lawsuit filed against Johnson & Johnson
21-year-old Aaron Banks files a lawsuit against J&J over trauma he allegedly suffered due to gynecomastia. Banks claims he took Risperdal between 1999 and 2004. The case was settled confidentially out of court in 2012.
2012 – J&J reaches $181 million settlement
J&J reaches a $181 million settlement with 36 states and the District of Columbia for off-label marketing of Risperdal. Plaintiffs also claimed that the company downplayed the implied adverse effects of the drug. Also in 2012, Bloomberg news reported on over 400 Risperdal lawsuits filed across the U.S., the vast majority of which alleged gynecomastia injuries. 2012 was also the year J&J offered $2.2 billion to the Department of Justice to call off the investigation.
2013 – Johnson & Johnson agrees to settlement
Johnson & Johnson agrees to pay $2.2 billion settlement with the U.S. government for illegally marketing Risperdal.
2016 – Lawsuits continue to pile up
Lawsuits continue to pile up against J&J. At least 3 recent verdicts have given hope to more than 1,700 Risperdal gynecomastia lawsuits pending in Pennsylvania’s Philadelphia Court of Common Pleas. The cases have been consolidated to form a mass tort program – all plaintiffs allege that gynecomastia and other adverse events were caused by Risperdal; that Janssen may have concealed knowledge of the side effects; and that it failed to adequately warn of these risks, thereby claiming the company was negligent (Risperdal Litigation case number 100300296).
- “Breast Enlargement in Males”. MedlinePlus, U.S. National Library of Medicine.
- ”Diagnosis and Management of Galactorrhea”. American Family Physician. August 1, 2004.
- ”Risperidone and Risk of Gynecomastia in Young Men”. Journal of Child and Adolescent Psychopharmacology. November 2015.
- ”Effects on Self-Esteem and Social Functioning Support ‘Early Intervention and Treatment”. Plastic and Reconstructive Surgery. American Society of Plastic Surgeons. April 2, 2013.
- ”Gynecomastia (enlarged breasts in men) Treatments and Drugs”. Mayo Foundation for Medical Education and Research. January 2, 2014.
- “Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigations”. The United States Department of Justice (DOJ). November 4, 2013.
- ”Attorney General Eric Holder Delivers Remarks at the Johnson & Johnson Press Conference”. The United States Department of Justice (DOJ). November 4, 2013.
- ”J&J to Pay $2.2 Billion in Risperdal Settlement”. The New York Times. November 4, 2013.
- ”J&J hit with $1.1 billion Risperdal penalty in Arkansas”. Reuters. April 11, 2012.