Risperdal® is an antipsychotic medication that was approved by the Food and Drug Administration (FDA) in 2004. Risperdal® is known as an “atypical antipsychotic” medication, and works by altering brain chemistry in order to help alleviate the symptoms associated with serious mental and mood disorders.
Unfortunately, Risperdal® has led to serious and distressing side effects among many patients that it was designed to help.
Off Label Use of Risperdal® Linked to Gynecomastia
Although Risperdal® was originally approved as a treatment for schizophrenia, manufacturer Janssen Pharmaceuticals and parent company Johnson & Johnson marketed the drug as a safe and effective treatment for children suffering from bipolar disorder and Autism.
When drug manufacturers encourage doctors to prescribe medications to treat conditions for which the FDA did not originally approve the drug, it is known as “off-label” usage.
Off label use of Risperdal® resulted in devastating side effects for many patients.
Many adolescent boys that took Risperdal® for the purposes of treating bipolar disorder or Autism experienced a severe imbalance of hormones that caused the development of male breasts, a condition known as gynecomastia.
Gynecomastia can cause severe mental and emotional distress in young men. This is especially true for the vulnerable adolescent patients taking Risperdal® in the hopes of treating serious mood and psychological disorders. In severe cases, some patients even required mastectomy surgery to remove the breasts they grew as a result of taking Risperdal®.
Another population at risk of serious, or even fatal side effects from Risperdal® are elderly patients taking the drug to treat Dementia-related psychosis.
The FDA announced in 2005 that elderly patients faced an increased mortality rate when taking Risperdal®. The FDA requested that a “black box” warning label be added to packages of Risperdal® noting that the drug is not approved for this type of usage. “Black box” warning labels are reserved only for drugs that the FDA determines poses a “life-threatening” risk to patients.
Other side-effects of Risperdal® can include:
- Nausea & Vomiting
- Fatigue & Sedation
Manufacturers Johnson & Johnson & Janssen Pharmaceuticals Facing Numerous Lawsuits
By marketing Risperdal® for dangerous, off-label use, manufacturers Janssen Pharmaceuticals and Johnson & Johnson generated billions in corporate profits. Sales of the medication peaked in 2007 at $4.5 billion. By failing to warn patients about the serious potential health risks of taking Risperdal® for off label use, Janssen Pharmaceuticals and Johnson & Johnson put profits above consumer safety.
Now, these manufacturers are facing numerous lawsuits alleging that Janssen Pharmaceuticals and J&J worked to hide or ignore mounting evidence of severe side-effects caused by Risperdal®.
In 2015, Johnson & Johnson lost the first Risperdal® lawsuit to go to trial. Janssen Pharmaceuticals and J&J were ordered by a Philadelphia jury to pay over $2.5 million in damages for failing to disclose the risks of off-label usage of Risperdal®.
If a loved one is taking the antipsychotic medication Risperdal® and required mastectomy surgery for the treatment of gynecomastia, or suffered any other serious side effect, The Yost Legal Group is here to protect your rights.
Call us today at 1-800-YOST-LAW (967-8529) for a FREE, confidential consultation.
At The Yost Legal Group, we have extensive experience standing up to major pharmaceutical manufacturers on behalf of our clients. The Yost Legal Group is made up of experienced attorneys ready to pursue your possible case with compassion and determination.
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