Drug companies that manufacture and market antipsychotic medications claim that mental illness is the result of a chemical imbalance in the brain that can only be successfully treated with psychotropic drugs, like Risperdal. However, there are a number of potential side effects associated with Risperdal use one of the most popular antipsychotic medicines on the market today, including breast growth in boys (gynecomastia), tardive dyskinesia, significant weight gain, metabolic problems, and even an increased risk of death among patients with dementia, all of which have raised serious concerns about the safety of the antipsychotic medication. If you took Risperdal and you have since suffered from gynecomastia or another major side effect, our consumer advocates at the Consumer Justice Foundation can help put you in touch with an experienced drug injury attorney in your area.
Risperdal and other drugs that belong to the same class of atypical antipsychotic medications work by altering the levels of dopamine and serotonin in the brain. Unfortunately, the very thing that makes Risperdal so effective is also what may cause serious side effects, possibly brought on the abnormal levels of hormones in the body. If light of the alleged risk of serious side effects from Risperdal, many patients are seeking alternative treatments for psychiatric disorders, including the following:
Risperdal, also known by its generic name risperidone, is a powerful antipsychotic drug manufactured by pharmaceutical giant Johnson & Johnson and its Janssen Pharmaceuticals subsidiary. The drug is commonly used to treat psychiatric conditions like schizophrenia, the mixed and manic states associated with bipolar disorder, schizoaffective disorder, and irritability in individuals with autism. Known as an “atypical” antipsychotic drug, Risperdal targets serotonin in addition to dopamine, which may be why the medication is seen as more effective than traditional antipsychotics at reducing psychiatric symptoms. Risperdal was initially approved by the U.S. Food and Drug Administration (FDA) in 1993 for the treatment of psychotic disorders, although the agency later approved the antipsychotic for additional uses.
The safety of J&J’s blockbuster antipsychotic drug has been questioned recently, amid reports suggesting that Risperdal may lead to enlarged breasts in men, a condition commonly known as gynecomastia. Gynecomastia can affect one or both breasts in men, sometimes unevenly, and, while it may not pose any serious health risks for patients, experts have suggested that the condition can cause emotional or psychological trauma. Men suffering from male breast growth may experience one or more of the following symptoms:
According to health experts, Risperdal use may result in increased levels of prolactin, a hormone that regulates breast growth in milk production. In women, this can cause spontaneous milk production, while in men, it can lead to breast growth side effects. The potential connection between J&J’s Risperdal antipsychotic and male breast growth was first identified in 1999, when the journal Psychopharmacology published research linking Risperdal and gynecomastia when used with the antidepressant drug Prozac. In 2006, another study published in the Journal of Clinical Psychopharmacology indicated that prolactin levels can increase dramatically when Risperdal is administered to adolescents. In 2009, another study published in the Journal of Child and Adolescent Psychopharmacology suggested that elevated prolactin levels linked to Risperdal use persisted for up to two years.
Research has shown that Risperdal may increase levels of prolactin, a hormone in the body that causes the enlargement of breast tissue. Many man who experienced abnormal breast growth after taking Risperdal have pursued legal action against Johnson & Johnson and Janssen Pharmaceuticals as a result of their injuries. The following are some of the most recent lawsuits brought over Risperdal breast growth and other side effects:
January 2012 – A whistleblower lawsuit in Texas results in a $158 million settlement from Johnson & Johnson.
September 2012 – J&J agrees to settle a Risperdal breast growth lawsuit filed by a young man who suffered gynecomastia side effects after taking the antipsychotic drug as a child.
November 4, 2013 – Johnson & Johnson agree to pay $2.2 billion to resolve criminal and civil fines over the company’s illegal marketing of Risperdal for off-label uses not approved by the FDA.
November 13, 2013 – Evidence emerges suggesting that J&J and Janssen Pharmaceuticals intentionally withheld information from clinical trials regarding a risk of Risperdal side effects.
March 11, 2014 – J&J and Janssen agree to pay $5.9 million to resolve a Risperdal lawsuit filed by Montana’s state attorney general, Tim Fox, who accused the drug companies of engaging in misleading and illegal Risperdal marketing practices.
March 20, 2014 – The Arkansas Supreme Court rejects a $1.2 billion judgement against J&J for illegally marketing Risperdal for off-label uses.
May 14, 2014 – The Pennsylvania judge presiding over more than 500 Risperdal lawsuits bans plaintiffs from seeking punitive damages from J&J and Janssen.
June 24, 2014 – J&J faces a Risperdal lawsuit filed by a 27-year-old man who experienced significant breast growth that required a double mastectomy for removal.
December 18, 2014 – More than 1,000 Risperdal lawsuits have been filed against J&J and Janssen, including one case involving a boy from Louisiana who was diagnosed with gynecomastia after taking Risperdal as a child.
January 27, 2015 – A doctor who prescribed Risperdal to a child who suffered male breast growth testifies that he would have reevaluated his decision if he knew about the risk of gynecomastia from Risperdal treatment.
January 30, 2015 – Dr. David Kessler, pediatrician and former commissioner of the FDA, testifies in trial that J&J failed to provide doctors with adequate warnings about the risk of Risperdal breast growth side effects.
February 12, 2015 – J&J faces a Risperdal lawsuit filed by a man who was prescribed the antipsychotic as a child and subsequently developed enlarged breasts.
March 18, 2015 – A Philadelphia jury orders J&J to pay $2.5 million to a 22-year-old autistic man who developed size 46DD breasts after taking Risperdal off-label as a child.
May 27, 2015 – J&J settles a Risperdal gynecomastia lawsuit just hours into opening arguments.
April 11, 2005 – The FDA issues a safety announcement indicating that atypical antipsychotic treatment in patients with dementia-related psychosis may result in an increased risk of death.
August 2008 – The FDA issues an alert for healthcare professionals, indicating that the risk of mortality described in the FDA’s 2005 safety announcement has been highlighted in a Risperdal “black box” warning.
Johnson & Johnson’s Risperdal antipsychotic drug made billions for the pharmaceutical company, but a growing body of research has linked the popular medication to serious side effects like heart attacks, strokes, movement disorders like tardive dyskinesia and breast growth in boys. More and more former Risperdal users have become aware of the alleged risk of Risperdal side effects recently, but the link between Risperdal and male breast growth has been evidence for years, with Risperdal gynecomastia research dating back to at least 1999.
1999 – The medical journal Psychopharmacology publishes research linking Risperdal to breast growth in males when taken with the best-selling antidepressant drug Prozac.
June 2003 – Research published in the medical journal Pharmacotherapy highlights 131 cases of high blood sugar linked to Risperdal treatment.
March 2006 – The American Journal of Epidemiology publishes a study that links Risperdal treatment to weight gain that “may contribute to the increased risk of diabetes.”
April 2006 – A study published in the Journal of Clinical Psychopharmacology finds that “Risperidone administered to adolescents at doses commonly used for the treatment of psychotic symptoms can strongly increase prolactin levels, with clinical consequences such as gynecomastia.”
March 18, 2014 – Research presented at an annual meeting of the American Association for Geriatric Psychiatry indicates that older men taking Risperdal have a 69% increased risk of suffering gynecomastia side effects.
August 21, 2014 – A study published in the Annals of Internal Medicine links the use of atypical antipsychotic drugs like Risperdal in older adults to a 73% increased risk of hospitalization for acute kidney damage and other complications.
August 22, 2014 – Middle-aged men who take the antipsychotic Risperdal have a 69% increased risk of suffering male breast growth, according to research published in the Journal of Clinical Psychopharmacology.
September 9, 2014 – New research published in the Journal of the American Academy of Child & Adolescent Psychiatry indicates that 0.72% of children taking antipsychotic medications like Risperdal develop diabetes, compared to 0.27% of children who don’t take the drugs.
In the United States alone, close to 80 million people take psychiatric medications like Risperdal, including 8.5 million children, and many of these drugs are known to cause serious side effects in users. Take Risperdal for example; the widely-used antipsychotic medication has been associated with an increased risk of breast growth in boys and young men, and product liability lawsuits filed on behalf of former Risperdal users who claim to have suffered serious injuries from the drug allege the following:
Mounting research has established a potential link between Risperdal use and serious side effects like enlarged breast tissue in young men, and those affected by these complications are seeking legal action. In fact, in September 2012, Johnson & Johnson settled for an undisclosed amount the first of what would be over 100 Risperdal lawsuits related to breast growth in boys, and hundreds more have been filed against the drug maker for other alleged Risperdal-related complications. If you have experienced a major side effect like male breast growth, and you believe the antipsychotic drug Risperdal to be the cause, consult a knowledgeable lawyer in your area for legal help. You may have grounds to file a Risperdal lawsuit against Johnson & Johnson, in order to pursue financial compensation for your injuries and medical expenses.