Safety Concerns and Side Effects
Risperdal and Invega have raised a number of safety concerns, especially those related to off-label use. Although doctors are allowed to prescribe drugs off-label at their own discretion, it is illegal for pharmaceutical companies to market their drugs for uses not approved by the FDA.
In 2005, a black box warning was added to Risperdal warning that the drug was linked to an increased risk of death in dementia patients. A black box warning, also known as a boxed warning, is the strongest warning required by the FDA. When a drug carries a boxed warning, it means that studies show that it has a risk of serious or life-threatening side effects. The warning was added following an FDA analysis of 17 placebo-controlled trials consisting of 5,106. The rate of death in placebo group was about 2.6 percent, compared to 4.5 percent in patients treated with antipsychotics. The FDA noted that most deaths were caused by cardiovascular issues (such as heart failure or sudden death) and infectious diseases (such as pneumonia), although the causes varied.
Risperdal and Invega are linked to gynecomastia, or the growth of abnormal breast tissue in males. The drugs are believed to trigger this effect because dopamine regulates levels of prolactin, the hormone responsible for milk production. There are a number of lawsuits filed on behalf of patients who developed gynecomastia, allegedly due to the antipsychotics. There were over 130 lawsuits involving Risperdal/Invega and gynecomastia as of September 2012.
Risperdal and Invega may also trigger metabolic changes that increase the risk of heart disease, including hyperglycemia, dyslipidemia, weight gain and diabetes. This risk of diabetes associated with antipsychotics is compounded by the fact that patients with schizophrenia are already at an increased risk of type 2 diabetes.
These powerful antipsychotics can also cause movement disorders, including tardive dyskinesia, tardive dystonia and parkinsonism. These conditions lead to involuntary bodily movements, which can range from short, quick motions to slow, painful twisting ones.