In recent months, Johnson & Johnson has lost three consecutive class action lawsuits over marketing tactics of its controversial – yet highly profitable – antipsychotic medication Risperdal (generic: risperidone). Then in September 2012, the company settled an individual Risperdal lawsuit filed on behalf of a young man who developed female breasts after being treated with the drug for a period of five years. If you’ve been injured by Risperdal side effects, it’s important to understand that you are not alone, and that Risperdal lawyers are now filing lawsuits in courthouses around the country.
What’s the problem?
Manufactured and marketed by Janssen Pharmaceuticals (a subsidiary of healthcare giant Johnson & Johnson), Risperdal was approved by the U.S. Food & Drug Administration (FDA) in 1993 for the treatment of schizophrenia and acute mania, or mixed episodes of bipolar disorders. Risperdal is also commonly prescribed in a so-called ‘off-label’ capacity (for which it was neither tested nor approved by the FDA) for the treatment of behavioral disorders in the elderly such as dementia, attention deficit disorder (ADD) in children, as well as depression, anxiety and autism. And though it has proven to be considerably effective at treating a number of these serious medical conditions, Risperdal has also recently been linked to a large number of serious, potentially life-threatening side effects.
One of the ways Risperdal works in treating mental disorders is by blocking dopamine in the brain. It is believed that this may cause the pituitary gland to release prolactin, the hormone that stimulates the growth of breast tissue and production of milk in women. For women, prolactin can cause spontaneous milk production when present in excess quantities. In men, this excess prolactin can lead to Risperdal gynecomastia.
Symptoms of Risperdal gynecomastia may include:
- Nipple discharge (The condition may develop in one or both breasts)
Risperdal is associated with the following adverse health complications:
- Production of prolactin
- Pituitary tumors
- Tardive Dyskinesia
- Neuroleptic Malignant Syndrome (NMS)
- Increased risk of sudden death from heart attack
- Diabetes, hyperglycemia and other blood sugar side effects
- Weight gain, potentially rapid and extreme
- Suicide, suicidal thoughts
- Bone loss
- Increased mortality in the elderly with dementia and related psychosis
More moderate side effects linked to Risperdal have been reported to include:
- Abdominal pain
- Dry mouth
- Sore throat
- Abnormal walk
- Chest pain
- Involuntary movements
- Nasal inflammation
- Decreased activity
- Decreased sexual desires
- Lack of coordination
- Dry skin
- Difficulty urinating
- Heavy menstruation
- Weight gain
- Lethargic feelings
- Join pain
- Difficulty ejaculating
- Respiratory infection
Although Risperdal drug side effects like gynecomastia do not pose a significant risk to the patient’s health, the psychological and emotional damage can be quite serious. The embarrassment that often results from the condition can affect the patient’s social behavior and overall lifestyle.
In mild to moderate cases of Risperdal gynecomastia, it may be possible to use Liposuction to remove the breast tissue that has developed. However, severe cases of Risperdal drug side effects such as gynecomastia often must be treated with surgical procedures, including breast reduction or mastectomy.
OTHER SERIOUS SIDE EFFECTS
The most serious side effects associated with Risperdal are abnormal breast development in boys, movement disorders and diabetes.
-Breast Development in Boys
Gynecomastia is the enlargement of breast tissue in males, particularly adolescents. Risperdal greatly increases levels of prolactin, a hormone that stimulates production of milk in pregnant women. This increase may be one reason that boys taking Risperdal experience abnormal breast growth.
In clinical trials involving 1,885 children taking Risperdal, 43 experienced abnormal growth of breast tissue. Since the FDA approved the drug for use in children, hundreds of boys have developed breasts while on the medication — including in some cases breasts as large as “D” cups, according to Forbes.
In rare cases, patients claim to have developed galactorrhoea, or unexpected breast milk production. This rare side effect was observed in clinical trials.
One of the most dangerous Risperdal drug side effects is an increased risk of movement disorders such as Extrapyramidal symptoms (loss of control over movement) and tardive dyskinesia (involuntary, repetitive movements).
While most antipsychotic drugs carry an increased risk of movement disorders, atypical antipsychotics – and Risperdal, in particular – seem to have an even greater incidence of EPS and tardive dyskinesia. If a patient notices any loss of motion or control while taking Risperdal, a doctor needs to address the problem before it becomes irreversible. Although addressing EPS and tardive dyskinesia often involves stopping treatment with antipsychotics, some patients may require continuation of Risperdal therapy despite the presence of movement disorders.
Patients with schizophrenia are already at an increased risk of diabetes mellitus (type 2 diabetes) compared with the general population. On top of this, studies suggest a relationship between antipsychotic use and hyperglycemia-related events (high blood sugar incidents). Patients on any antipsychotic should monitor and control their glucose levels.
Risperdal has been associated with elevated blood sugar levels and diagnoses of type 2 diabetes, including, in rare cases, extreme ketoacidosis (shortage of insulin) resulting in coma or death. Studies suggest that the risk of type 2 diabetes is higher with atypical antipsychotics such as Risperdal than with traditional antipsychotics.
-Heart Problems and Death
Risperdal carries a black-box warning about the risk of death in elderly patients with dementia-related psychosis. Risperdal is not recommended for these patients.
All antipsychotics, including Risperdal, have been associated with the risk of sudden cardiac death due to an arrhythmia (irregular heart beat). Another rare but serious side effect is neuroleptic malignant syndrome (NMS), a life-threatening adverse effect of antipsychotics that occurs in less than 1 percent of patients.
2013 RISPERDAL DRUGSIDE EFFECTS SETTLEMENT
On November 4, 2013, Johnson & Johnson agreed to resolve criminal and civil investigations into the marketing of Risperdal and other widely-prescribed medications by paying over $2.2 billion, one of the largest penalties ever levied against a company for healthcare fraud. According to the agreement, J&J’s Janssen division will plead guilty to misbranding Risperdal for unapproved uses, as well as for paying kickbacks to physicians and to Omnicare Inc., the largest pharmacy for nursing homes.