The History of Risperdal FDA Warnings

Risperdal was approved by the U.S. Food and Drug Administration (FDA) in 1994. It is recognized as a medication used to treat psychological issues. The antipsychotic drug is approved for use in patients with schizophrenia, schizoaffective disorder, bipolar disorder, and autism with irritability. Despite the drug’s effectiveness for these disorders, Risperdal side effects can be life changing or life threatening for people of different age groups.

In response, the FDA issued a black-box warning for Risperdal in 2005. The administration issued this alert so elderly users were aware of the fatal Risperdal side effects. Based on research at that time, there was a significantly higher risk of death in elderly individuals taking Risperdal. The black-box warning, the strictest warning given by the FDA, on the Risperdal bottle states that Risperdal use is not approved in elderly patients and can cause death in elderly patients.

Before this FDA black box warning, Risperdal was used freely in elderly patients with dementia induced psychosis. Even though Risperdal was never approved for use in elder patients with dementia, it was promoted for this by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. In 2013 Janssen Pharmaceuticals pleaded guilty to misbranding the drug and promoting it for use in elderly patients. The FDA punished J&J with criminal fines of 2.2 billion dollars.

Risperdal and Gynecomastia

Risperdal’s risks are not limited to elderly populations. Risperdal has been shown to cause gynecomastia in young patients. The Risperdal gynecomastia connection has been established for years and affects young men. Risperdal has been shown to cause breast development as well as milk secretion in young men. This condition is caused by an increase in prolactin levels brought about by the drug. Gynecomastia has many negative psychological effects, such as lower self-esteem, mental health and social functioning.


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