Risperdal is an atypical antipsychotic medication which was the best-selling antipsychotic in the U.S. for a number of years. Despite its popularity, the medication has caused numerous controversies and has resulted in $ billions of fines, penalties and lawsuit settlements for injuries caused by Risperdal and misconduct by the manufacturer. One of the most notable controversies has been the subject of numerous media reports over breast tissue development or gynecomastia in young men and boys who were prescribed the drug as part of a behavioral control program.
|Manufacturer||Janssen Pharmaceuticals, division of Johnson & Johnson|
|Dosage form(s)||0.5mg tablet
0.5mg oral disintegrating tablet
1mg oral disintegrating tablet
2mg oral disintegrating tablet
3mg oral disintegrating tablet
4mg oral disintegrating tablet
1mg/ml oral solution
Risperdal Consta Injection 12.5 mg
Risperdal Consta Injection 25 mg
Risperdal Consta Injection 37.5 mg
Risperdal Consta Injection 50 mg
|Normal dosage||Adults 2 to 16mg daily
Children 0.25 to 6mg daily
Risperdal Consta Injection 12.5 to 50mg IM every 2 weeks
Risperdal (risperidone) is a second-generation antipsychotic which may work by blocking some of the effects of dopamine and serotonin in certain areas of the brain. It was designed to be an improvement over an older antipsychotic, Haldol (haloperidol).
Risperdal is approved to treat:
- Schizophrenia in adolescents and adults
- Acute bipolar mania in children, adolescents and adults
- Adjunctive treatment for bipolar disorder in children, adolescents and adults
- Irritability associated with autistic disorders
Risperdal is not approved as a pharmaceutical “restraint” for sedation. Some critics have accused the manufacturers of promoting Risperdal inappropriately for overuse and improper use.
Risperdal Side Effects
Common side effects of Risperdal may include:
- Abdominal pain
- Weight gain
- Uncontrolled movements
Similar to other atypical antipsychotic medications, Risperdal may be linked to more serious health concerns including:
- Neuroleptic malignant syndrome (NMS)
- Tardive dyskinesia (TD)
- High blood sugar
One of the biggest controversies caused by Risperdal use is the development of breast tissue in young male users, known as gynecomastia. Gynecomastia is a permanent change which requires reconstructive surgery or “breast reduction” to correct. Medical experts believe Risperdal triggers gynecomastia because the drug stimulates the production of prolactin, a hormone that is usually found in pregnant or nursing women.
A 2006 study confirmed the risk of gynecomastia in boys and adolescent males with Risperdal use and also showed evidence Risperdal triggers early breast development in young female users. The drug was also shown to cause lactation in girls, boys with gynecomastia, and in women who were not pregnant or nursing. A 2007 report in the Wall Street Journal reported up to 70% of children with gynecomastia developed the disorder because of Risperdal use.
Risperdal Inappropriate Marketing Accusations
In addition to the health side effect associated with Risperdal, Janssen has also been accused of using inappropriate marketing techniques to promote Risperdal. Lawsuits claim the drug was marketed for unapproved uses in children and adults, including for the treatment of ADHD, chemical restraint, and schizoaffective disorder. It should be noted that it is legal for doctors to prescribe medications for off-label, unapproved uses, but it is illegal for drug manufacturers to promote or market the drug for such uses.
Possible harm caused from the misuse of the drug dates back to 2001, and Janssen and its parent company, Johnson & Johnson, have already paid more than $5 billion in settlements and fines for inappropriate marketing and use.
FDA Warnings and Risperdal Lawsuits
In 2005, several years after Risperdal problems began to emerge, Janssen was required by the U.S. Food and Drug Administration to add a black box warning to Risperdal.
The black box statement was added as a result of reports that older patients treated for dementia with atypical antipsychotics had an increased risk of death when compared to patients in a placebo control group. The majority of the deaths appear to have been caused by heart related ailments such as heart disease and infections like pneumonia.
Atypical antipsychotics in general have been linked to increasing the risk of obesity, high cholesterol, as well as diabetes in patients treated with these medications, including Risperdal. The risk of diabetes is increased further in those patients that have additional risk factors such as obesity or family history of diabetes. Patients who have additional risk factors for diabetes are advised to undergo glucose testing before beginning treatment with atypical antipsychotics such as Risperdal. Patients should be monitored for any symptoms of hyperglycemia that may develop during treatment with Risperdal.
The black box warning only addressed the risk for elderly dementia patients using the drugs, despite more than 1200 adverse event reports, including 31 deaths involving children. In 2008, the FDA concluded that no further warnings were needed regarding Risperdal but in 2010, the public became aware of multiple occurrences of gynecomastia in adolescents and children as young as 4 years old.
Risperdal Settlements and Fines
The first Risperdal gynecomastia lawsuit was filed by a 21-year-old man who used Risperdal for at least five years and developed breast tissue. A former Johnson & Johnson CEO was due to testify in the trial, but the company settled the case on the first day of trial for an undisclosed amount. Later that same year, Johnson & Johnson was fined $1.2 billion in an Arkansas court for improper marketing that downplayed the risks of the drug. The fine also included more than 240,000 cases of medical fraud.
Since those first events, Johnson & Johnson and Janssen have faced abundant legal action regarding Risperdal, including:
- $181 million settlement in 36 states and the District of Columbia for improper marketing
- $327 million settlement in South Carolina
- $258 million settlement in Louisiana
- $158 million settlement in Texas
- $2.2 billion in fines and penalties levied by the US Department of Justice to avoid prosecution for misbranding
- 420 lawsuits including claims of gynecomastia in 100 cases, six of which were due to call the FDA Commissioner to testify in the trial, but were settled for an undisclosed amount instead
Janssen Pharmaceuticals and Johnson & Johnson are still under investigation and may continue to face hundreds of lawsuits regarding serious and life-threatening events caused by Risperdal.
Past Risperdal medical injury lawsuits have awarded settlements to compensate for past and future medical costs, pain and suffering, lost wages and in some cases, punitive damages. Consultation with a Risperdal lawyer or attorney will help determine if you have a case.