What is Risperdal? What is Risperdal Used for?
Risperdal, known generically as risperidone, is a second-generation antipsychotic first approved by the Food and Drug Administration (FDA) in 1993. Risperdal uses include the treatment of schizophrenia, manic and mixed episodes of bipolar I disorder, and irritability with autism. Beginning in 2006, Risperdal became one of the few antipsychotics approved for use in children.
Risperdal is often used off-label to treat patients for things including behavioral conditions such as major depressive disorder, obsessive-compulsive disorder, attention deficit hyperactivity disorder (ADHD), and Tourette’s syndrome.
The drug has also been used to treat psychosis in patients suffering from dementia. In 2005, the FDA ordered a Boxed Warning be added to the labels of Risperdal regarding the increased risk of death and stroke in older adults with dementia. Three years later, the warning was extended to other second-generation antipsychotics.
Risperdal Side Effects
Common Risperdal side effects include:
- Extrapyramidal effects such as sudden, often jerky, involuntary motions of the head, neck, arms, body or eyes
- Weight gain
- Increased appetite
- Sleep problems
- Nausea and/or vomiting
- Skin rash
More serious Risperdal side effects include:
- Increased risk of death in elderly patients with dementia-related psychosis (Boxed Warning)
- Cerebrovascular adverse events, including stroke, in elderly patients with dementia-related psychosis (Boxed Warning)
- Neuroleptic malignant syndrome
- Tardive dyskinesia
- Metabolic changes such as hyperglycemia and diabetes
- Hyperprolactinemia, or elevated levels of prolactin
- Orthostatic hypotension (a decrease in blood pressure when first standing)
- Leukopenia, neutropenia, and agranulocytosis
- Cognitive and motor impairment
- Dysphagia (shortness of breath)
- Priapism (penis that remains erect for hours in the absence of stimulation or after stimulation has ended)
Risperdal can be one of the more difficult antipsychotics to come off of due to Risperdal withdrawal. Factors that influence withdrawal symptoms include how long the medication was taken, the dosage, and how quickly it was tapered.
Symptoms of Risperdal withdrawal include anxiety, appetite changes such as feeling less hungry, reemergence of symptoms, concentration difficulties, confusion, delusions, depersonalization such as feeling unlike oneself, depression, dizziness, fatigue, hallucinations, headaches, irritability, insomnia, memory problems, mood swings, nausea and/or vomiting, suicidal thoughts, and sweating.
What are the Long-Term Side Effects of Risperdal?
Long-term use of Risperdal can increase the risk of developing certain Risperdal or risperidone side effects.
- Tardive dyskinesia can occur with long-term use of antipsychotics. Symptoms include grimacing, sucking and smacking of lips, or other movements that cannot be controlled.
- Diabetes, weight gain, high cholesterol and high triglycerides can occur with long-term use of Risperdal. A cluster of these symptoms, called metabolic syndrome, can increase the risk for cardiovascular disease, diabetes and stroke.
- Risperdal can increase blood levels of a hormone called prolactin. This is the same hormone produced by pregnant women to induce lactation. Long-term elevation of prolactin can lead to osteoporosis, or increased risk of bone fractures. Adolescent boys with high prolactin levels can develop gynecomastia, a condition defined by the growth of breast tissue in men.
What is Gynecomastia?
Gynecomastia is characterized by an enlargement of the male breast gland due to a hormonal imblance. It is not the same thing as excessive fat deposited on the chest. The condition can be caused by decreases in testosterone production due to aging, specific diseases and conditions, and certain medications, including Risperdal.
Gynecomastia usually goes away without treatment within six months to two years. But some cases that develop in puberty can persist beyond two years. This is called persistent pubertal gynecomastia.
How is Gynecomastia Treated?
In most cases, gynecomastia is diagnosed by a physical examination by a medical professional. Medical tests may be performed to confirm the diagnosis and/or establish the cause. Stopping medications and treating existing medical problems or health conditions that can cause enlarged breasts in men is the first-line treatment.
Some medications are used to treat gynecomastia. These drugs are more effective if used during the early stages of gynecomastia because scarring can occur after 12 months, which makes medicines less effective. Medications prescribed to treat gynecomastia include testosterone replacement therapy; Clomiphene, a medication used to stimulate ovulation in women; and the breast cancer treatment tamoxifen.
In severe or long-term cases, or in situations where medications are not effective, surgical removal is used, such as liposuction and/or reduction mammoplasty (breast reduction surgery).
Gynecomastia Side Effects
Breast enlargement in adolescent boys or men can be a source of embarrassment, making them a target for bullying, and can result in psychological consequences. Gynecomastia can also make breasts painful and tender, and in some cases can cause men to lactate.
Illegal Marketing of Risperdal
When Risperdal was first approved in 1993, it was not indicated for pediatric patients. Yet, Johnson & Johnson subsidiary Janssen Pharmaceuticals, makers of Risperdal, promoted the medication as safe and effective for young patients as well as the elderly with dementia.
In 1999 and again in 2004, the FDA told companies promoting Risperdal that they were misleading the public by omitting information about potentially fatal risks and claiming the medication was safer than other antipsychotics without adequate proof.
In 2005, the FDA required manufacturers of Risperdal to add a black box warning to the labels of the drug warning about the increased risk of death when used by elderly dementia patients. Three years later, the agency ordered manufacturers of other second-generation antipsychotics to add the same boxed warning to their products.
In 2006, the FDA approved the first pediatric indication for Risperdal – the treatment of irritability in autistic children. The label listed gynecomastia as a rare side effect despite internal documents that showed the risk of adolescent boys developing gynecomastia while taking Risperdal was actually considered statistically significant at about 4.5 percent. But the drug companies hid this information from the public as well as the FDA.
In 2013, after a decade-long investigation, Johnson & Johnson agreed to pay more than $2.2 billion in criminal and civil fines to settle accusations that it improperly marketed Risperdal to adults, children and people with developmental disabilities from 1999 to 2005. This marked one of the largest health care fraud settlements in U.S. history, according to the U.S. Department of Justice.
Johnson & Johnson and Janssen were also hit with lawsuits from 36 states and the District of Columbia for illegally marketing Risperdal from 1993 to 2004. In August 2012, the company reached an $181 million consumer fraud settlement with those states. The company was also hit with separate fines and court awards in several other states
Johnson & Johnson and Janssen face thousands of lawsuits that accuse them of hiding evidence from as far back as 2003 that showed Risperdal increased prolactin production, and upped gynecomastia risk in adolescent boys.
Most of the Risperdal litigation is pending in the Los Angeles Superior Court and the Philadelphia Court of Common Pleas in Pennsylvania, where some cases in a mass tort program have been tried.
The first case in the mass tort to go to trial involved the case of Adam Pledger, an Alabama man who claimed he grew size 46DD breasts after taking Rispedal for four years beginning in 2002 when he was 8. That was four years before the medication was approved for pediatric use. A Janssen sales rep allegedly visited Pledger’s pediatric neurologist more than 20 times to urge off-label use of the drug. In May 2016, a Philadelphia jury awarded Pledger $2.5 million finding Risperdal caused his injuries.
Other Risperdal trials have resulted in multimillion-dollar awards for plaintiffs including a landmark $70 million awarded to a Tennessee teen after jurors found that Janssen failed to warn the teenager and his parents that Risperdal could cause him to grow breasts.
Since then, the mass tort program in Philadelphia County has grown to more than 6,200 cases, and another 300 cases are pending in Los Angeles Superior Court.
Since 2012, pediatrician and former FDA commission Dr. David Kessler has served as an expert witness for plaintiffs in Risperdal cases regarding Johnson & Johnson and Janssen’s failure to warn about Risperdal side effects and the companies’ off-label promotion of the drug to children.
In 2015, Kessler testified that Johnson & Johnson knew as early as 2001 that the antipsychotic could cause gynecomastia in boys, long before the company added gynecomastia as a side effect on Risperdal’s safety label.
Beasley Allen is not currently taking any new Risperdal cases.