Risperdal (brand name risperidone) is a Federal Drug Administration-approved antipsychotic drug for treatment of several psychiatric and related conditions. It is manufactured by Johnson & Johnson and used to treat a variety of psych-disorders, including:
- Schizophrenia in children age 13-17. It is the only drug approved for this mental illness in this age group.
- Bipolar disorder in children age 10-17
- Irritability in minors with autism
Serious Problems Associated With Risperdal?
Risperdal has been linked to a host of severe health dangers. Clinical evidence shows a connection between Risperdal and gynecomastia, or the enlargement of breasts in boys. The 2006 Duke University study that found this side effect also found that girls on the drug produced breast milk before even reaching puberty. A study co-author said hormonal changes causing these abnormalities could be hazardous and several doctors told the FDA in 2008 that they were concerned about children taking the drug. Nonetheless, the agency refused to strengthen warnings about Risperdal.
Severe trouble with the drug has been found at the other end of the age spectrum as well. Risperdal is also used to treat aggression and psychosis in dementia patients — an “unapproved” use — the FDA requires Johnson & Johnson to place a black box warning on the drug — the most severe warning a drug can carry. The warning specifically states that elderly dementia patients taking Risperdal are more likely to die.
Other studies have associated Risperdal with an increased risk of Type II diabetes, especially in children. In 2003, the FDA suggested Johnson & Johnson sell Risperdal with a label warning patients of this risk, which it did, but regulators still found the company downplayed the greater dangers patients faced of diabetes and stroke.
Patients on Risperdal can also develop neuroleptic malignant syndrome, a potentially fatal reaction to the drug. Other symptoms of neuroleptic malignant syndrome are:
- Elevated white blood cell count
- Muscle tissue destruction
Successful Litigation Over Risperdal
Action against Johnson & Johnson over the use of Risperdal in children has found its way to the legal system, with highly unfavorable results for the company. Outcomes have included:
In 2013, Johnson & Johnson agreed to pay $2.2 billion to settle various federal allegations, including advertising Risperdal for unapproved uses, such as the treatment of vulnerable elderly dementia patients.
In 2012, a $181 million consumer fraud settlement with 36 states and the District of Columbia over allegations the drug maker promoted the drug for unapproved uses.
In 2011, a $327 million fine by South Carolina for exaggerating the effectiveness of the drug.
2011: Just as a Risperdal gynecomastia lawsuit was about to go to trial, Johnson & Johnson announced a settlement with the plaintiff, who said he grew breasts when he was 9. The amount was undisclosed.
What Should You Do?
If you or someone you know on Risperdal has died or suffered from gynecomastia, diabetes, tardive dyskinesia or other known symptoms, you should immediately contact the attorneys at Hodes Milman, LLP to find out about your rights. It is important your matter is immediately investigated.
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