Resperidone, sold under the trademark name Risperdal, is classified as an atypical antipsychotic drug that has been used to treat schizophrenia, bipolar disorder and in some cases, behavior issues in children with autism. Risperdal works by changing the chemical balance in the brain, affecting dopamine as an antagonist.
Janssen Pharmaceuticals, a division of Johnson & Johnson, had the drug approved by the FDA in 1993 and was the first manufacturer until it could be marketed generically in 2004. Since its release, there has been FDA warnings issued about Risperdal and reports linking it to diabetes, stroke, NMS, Tardive Dyskinesia and male breast enlargement as well as several lawsuits.
Side Effects Of Risperdal
The original use of Risperdal was meant to help control the chemical balance in the brain in persons with mental disorders such as schizophrenia. By controlling dopamine, a chemical that effects emotions, Risperdal was prescribed to help those with certain conditions function better mental and emotionally. However, the drug also had a potential to cause many side effects, including:
- Drowsiness, dizziness, nausea, muscle spasms and drooling
- Increased blood sugar, which can cause or worsen diabetes
- Weight gain and elevated cholesterol levels that can lead to heart disease
- Tardive Dyskinesia, which is a disorder where people have uncontrolled muscle movements, especially in the face, mouth, arms and legs
- Increase in prolactin, which effects breast and milk development in both females and males
- Neuroleptic Malignant Syndrome (NMS), a life-threatening neurological disorder
Male Breast Development Associated With Risperdal Use
One of the many side effects that Risperdal can cause is the increase in prolactin. While in woman this can lead to development of unwanted breast milk, stopped menstrual periods and make it difficult to become pregnant, in males it can also cause unwanted reactions. Higher levels of prolactin in males caused by Risperdal has been linked sexual dysfunction, reduction in sperm generation and breast development.
Young males that are given Risperdal can have breasts develop, a disorder called gynecomastia. This can be disfiguring and emotionally traumatizing for the boy. To combat this development, the young men often have the breast tissue removed through liposuction, or in severe cases, need a mastectomy.
Progressively Stronger FDA Warnings Relating To Risperdal
The FDA has issued several warnings and letters regarding Risperdal since it was approved in 1993. In 1999, a FDA warning was issued for use of Risperdal in patients 65 or over, in 2003 it required that Johnson & Johnson send letters to health care providers on the risk of diabetes and then chastised the company in 2004 for not following their previous direction regarding alerting physicians about the risk of diabetes and death with their product. In 2006 another warning was issued for the increased risk of death for patients dementia-related psychosis when using Risperdal.Lawsuits For Patients Who Have Suffered Adverse Side-Effects After Taking Risperdal
Both Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals Inc, have been in legal hot water for the illness and deaths that Risperdal has caused and how they handled the disclosure of information. In April 2012, an Arkansas judge and jury found the companies guilty of downplaying dangerous side effects of the drug and ordered $1.2 billion be paid in restitution. In August of 2012, Johnson & Johnson agreed to pay $181million to 36 states for claims that it promoted the drug for non-approved uses. Again in 2012, Johnson & Johnson settled a lawsuit for an undisclosed amount to one of over a hundred male patients with breast development alleged to be caused by Risperdal. Hundreds of other patients have filed claims as well for personal injuries due to the drug.
Rosenfeld Injury Lawyers LLC remains committed to fully prosecuting lawsuits on behalf of people who have suffered adverse side-effects after taking Risperdal. Call our office anytime for a free consultation about your legal rights in the wake of harm from Risperdal.
Resources for patients seeking information about Risperdal safety: