Risperdal Side Effects
Risperdal is a brand-name antipsychotic medication containing risperidone and marketed by Johnson & Johnson for the treatment of schizophrenia and bipolar mania in adults and children, and irritability associated with autistic disorder in children and adolescents. Risperidone is also available in generic formulations. Due to the risk of serious Risperdal side effects, the FDA recommends that doctors prescribing Risperdal use the lowest effective dose and “periodically re-evaluate the long-term usefulness of the drug for the individual patient.”
Serious Risperdal side effects include:
- Increased mortality in elderly patients
- Gynecomastia, or abnormal breast growth in men
- Movement disorders
- Neuroleptic malignant syndrome (NMS), a rare but potentially fatal neurological condition
Adverse reactions commonly reported in Risperdal clinical trials include:
- Upper respiratory tract infection
- Appetite increased
- Urinary incontinence
- Saliva increased
- Parkinsonism (tremors and difficulty with movement and balance)
- Dystonia (involuntary muscle contractions)
- Akathisia (extreme restlessness)
- Tardive dyskinesia (involuntary movements, especially facial tics)
- Abdominal pain
- Dry mouth
Black box FDA warning cites potentially deadly Risperdal side effects
Since Risperdal was approved by the FDA in 1993, controversy has surrounded the drug over illegal marketing and serious side effects. In 2008 the FDA added a “black box warning” to the Risperdal product label advising doctors and patients that the drug should not be used to treat dementia-related psychosis because numerous placebo-controlled trials had shown that risperidone significantly increased the rate of deaths in these elderly patients.
In 2012, Johnson & Johnson paid a $181 million consumer fraud settlement over charges that it had marketed Risperdal to elderly patients as a dementia treatment despite this grave danger and the fact that the FDA had not approved the drug for this use. The settlement served as a penalty for other fraudulent “off-label” marketing, including the company’s promotion of the drug for use in treating bipolar disorder, depression, and anxiety, and the company’s alleged downplaying of the dangers of Risperdal. As a result of the company’s illegal marketing, thousands of patients were unnecessarily and wrongly exposed to the risk of serious Risperdal side effects.
Risperidone side effects in men
Gynecomastia is the enlargement of breast tissue in men and boys, occurring as a risperidone side effect due to the drug’s tendency to elevate prolactin levels. Elevated prolactin, or hyperprolactinemia, stimulates the growth of mammary glands and depresses reproductive hormones like testosterone in men and estrogen in women, leading to a variety of unwanted side effects.
Adolescent boys taking Risperdal are especially susceptible to gynecomastia, which often causes them humiliation, confusion, and emotional trauma. At least 120 lawsuits have already been filed on behalf of adolescent boys who have developed gynecomastia, allegedly as a result of Risperdal.
Symptoms of hyperprolactinemia in men may include:
- Gynecomastia, or male breast growth
- Decreased libido
- Erectile dysfunction
Symptoms of hyperprolactinemia in women can include:
- Decreased libido
- Breast pain
- Painful sexual intercourse
- Reduced or absent menstruation in women
Johnson & Johnson may have hid Risperdal diabetes link
The FDA’s Risperdal side effects warnings include information about the possible connection between risperidone and hyperglycemia, obesity, and diabetes mellitus. Some reports say that antipsychotics including Risperdal have been implicated in hyperglycemic events such as coma and even death. One lawyer, representing a man who claims that Risperdal gave him diabetes, alleges that Johnson & Johnson hid studies that found a Risperdal diabetes link as early as 1999 in order to maximize their profits from selling the medication. Many Risperdal patients report significant weight gain after only 6-8 weeks of taking the drug.
Risperdal can cause debilitating and fatal neurological disorders
Neuroleptic malignant syndrome (NMS) is a neurological disorder that is potentially fatal if left untreated. Patients experiencing symptoms of NMS should discontinue use of Risperdal and seek immediate medical attention.
Symptoms of NMS include:
- Excessive sweating
- Muscle rigidity and/or tremors
- Confused or altered consciousness
- Agitation, delirium, or coma
- Unstable blood pressure
- Unstable heart rate
- Kidney failure
Risperdal is also associated with other neurological disorders, especially movement disorders such as tardive dyskinesia, akathisia, dystonia, Parkinsonism, and tremors. These disorders involve can involuntary movements, restlessness, muscle cramps, muscle spasms, loss of balance, and difficulty with movements. Some of these movement disorders may be irreversible and leave Risperdal patients with permanent disabilities.
In addition to the commonly reported adverse events listed above, the FDA also warns consumers about less common Risperdal side effects. Risperdal can cause orthostatic hypotension, a condition in which the blood pressure drops suddenly when a patient stands or stretches. This can cause dizziness, lightheadedness, vision and hearing problems, and in some cases, even seizures or fainting spells.
Risperdal can cause low white blood cell count, seizures, cognitive and motor impairment, thermal dysregulation (hyperthermia or hypothermia), priapism, and a condition called dysphagia in which a patient’s esophagus no longer moves food efficiently, which can cause inhalation of food particles and potentially pneumonia.
Finally, the FDA warns that patients who take Risperdal may attempt suicide due to their underlying mental illness and that patients should be given a small quantity of tablets at a time and monitored closely in order to decrease the risk of overdose.
Lawsuits and settlements over Risperdal side effects
In September 2012, Johnson & Johnson settled a Pennsylvania Risperdal lawsuit alleging that the drug had caused gynecomastia in a young man for an undisclosed amount of money. Since then, the firm has settled dozens more gynecomastia lawsuits. The company has also been fined $1.2 billion in Arkansas and $327 million in South Carolina, settled a Texas case for $158 million, and been ordered to pay $258 million in damages by a jury in Louisiana.
The biggest Risperdal settlement, however, involves a reported $2.2 billion settlement with the federal government over the marketing of Risperdal and other drugs for off-label uses. If Johnson & Johnson settles these federal probes, the admission of culpability could lead to even more Risperdal lawsuits.
- FDA, Label for Risperdal, http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020272s056,020588s044,021346s033,021444s03lbl.pdf
- Bloomberg News, J&J Hid Risperdal Studies to Boost Drug Sales, Lawyer Says, http://www.bloomberg.com/news/2012-02-02/j-j-hid-risperdal-studies-to-boost-drug-sales-lawyer-says-at-n-j-trial.html
- Pharmalive, J&J Settles Suit Over Risperdal And Male Breasts, http://www.pharmalive.com/jj-settles-suit-over-risperdal-and-male-breasts
- Pharmalive, J&J May Pay $2.2B To Settle Risperdal Probes, http://www.pharmalive.com/jj-may-pay-22b-settle-risperdal-probes
- Pharmalive, Will Male Breasts Derail A J&J Settlement Over Risperdal Marketing? http://www.pharmalive.com/will-male-breasts-derail-a-jj-settlement-over-risperdal-marketing
- New York Times, J.&J. Fined $1.2 Billion in Drug Case, http://www.nytimes.com/2012/04/12/business/drug-giant-is-fined-1-2-billion-in-arkansas.html
- New York Times, Johnson & Johnson Unit Settles State Cases Over Risperdal, http://www.nytimes.com/2012/08/31/business/johnson-johnson-unit-settles-state-cases-over-risperdal.html?_r=3&
- Forbes, J&J Sees Male Breasts And Quickly Settles Risperdal Suit, http://www.forbes.com/sites/edsilverman/2012/09/11/jj-sees-male-breasts-and-quickly-settles-risperdal-suit/