Risperdal, a medication manufactured and marketed by pharmaceutical giant Johnson & Johnson subsidiary won approval from the Food and Drug Administration in 1993.
The medication was approved after testing and reviews processes directly for the treatment of schizophrenia and mixed episodes of bipolar disorders.
Since then, mistakes because of a name similarity with another medication and illegal sales and marketing practices involving unapproved off-label uses have forced the companies to defend themselves against Risperdal lawsuits and make warning label changes for consumers and health care professionals.
The Risperdal lawsuits most commonly involve a condition known as gynecomastia, a benign enlargement of breast tissue in males, which can have devastating physical and emotional effects.
These victims are seeking compensation for medical costs, pain and suffering and other expenses they say have been caused by side effects that they were not warned about.
Risperdal also has been linked to following health complications, some of which are life-threatening:
- Heart attacks
- Mortality in the elderly with dementia and related psychosis
- Suicidal thoughts
- Pituitary tumors
- Prolactin production
- Pituitary tumors
- Tardive Dyskinesia
- Neuroleptic Malignant Syndrome (NMS)
- Sudden weight gain
- Bone loss
Janssen Pharmaceuticals and Johnson & Johnson, have pleaded guilty and agreed to pay more than $1.67 billion in criminal fines and civil settlements over the way they marketed and sold Risperdal for off-label uses not approved by the FDA.
Another issue with Risperdal developed in 2011, when the FDA issued a warning alerting the public to medication error reports in which patients were given risperidone (Risperdal) instead of ropinirole (Requip) and vice versa. In some cases, patients who took the wrong medication needed to be hospitalized.
The FDA determined that the factors contributing to the confusion between the two products include:
- Similarities of both the brand (proprietary) and generic (established) names
- Similarities of the container labels and carton packaging
- Illegible handwriting on prescriptions
- Overlapping product characteristics, such as the drug strengths, dosage forms, and dosing intervals.
The FDA also issued the following recommendation:
“Patients who take Requip, Risperdal, or their generic equivalents are reminded to take note of the name and appearance of their medication, know why they are taking it, and to ask questions when the medication appears different than what they expect.
“Healthcare Professionals are reminded to clearly print or spell out the medication name on prescriptions and make certain their patients know the name of their prescribed medication and their reason for taking it.”