05/02/2014 05:05
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At present, the U.S. Food and Drug Administration (FDA) has not ordered a recall of Risperdal or required that new warnings be posted on the drug. Legal experts continue to advise that those affected may seek compensation from the manufacturer for all of their damages by filing Risperdal gynecomastia lawsuits.
Following reports that the best-selling antipsychotic medication Risperdal may cause gynecomastia or the abnormal breast growth in children and adult males, hundreds of the affected patients have decided to seek due compensation from the manufacturer, Johnson & Johnson (J&J) and its Janssen unit.
Through the years, J&J has faced extensive legal problems over their Risperdal promotions. According to reports, the company illegally marketed the Risperdal for off-label uses that were never approved or established as safe and effective by the FDA.
According to news reports, Janssen plead guilty to a misdemeanor criminal charge over misbranding Risperdal for uses not approved by the U.S. Food and Drug Administration (FDA), including treating elderly patients with dementia. Aside from Janssen settling civil claims that it marketed Risperdal without approval for the elderly, children and the mentally disabled; it also settled the claim that the company paid kickbacks to doctors and to Omnicare Inc., a leading pharmacy for nursing homes.
However, while Janssen “accepts accountability” for the actions explained in the misdemeanor plea, the civil settlement “is not an admission of any liability or wrongdoing, and the company expressly denies the government’s civil allegations,” J&J expressed.
The health complications and other side effects brought by Risperdal have been documented by the victimized patients, healthcare groups, legal experts, and the FDA. The Journal of Clinical Psychopharmacology published a research study in 2006 revealing that prolactin levels may significantly increase when Risperdal was taken by adolescent males. Furthermore, in 2009, another study by the Journal of Child and Adolescent Psychopharmacology found that increased prolactin levels remained for as long as two years after the patients stopped taking Risperdal.
References:
healthcentral.com/schizophrenia/h/is-gynecomastia-from-risperdal-reversible.html
medscape.com/viewarticle/571416_6
ehealthme.com/ds/risperdal/gynecomastia