Users of the drug Risperdal and members of the medical community continue to voice their concern over the antipsychotic medication manufactured by Ortho-McNeil-Janssen Pharmaceutical and Johnson & Johnson. The drug was originally approved by the FDA in 1993 for the short-term treatment of schizophrenia in adults, and later received approval for treating autism-related behaviors and schizophrenia and bipolar disorders in adolescents.
Though effective for its intended uses, studies have shown a link between Risperdal and gynecomastia, which is the development of breast tissue in males. The tissue is non-cancerous and physically harmless, but the psychological and emotional trauma is long-lasting. For many, ending Risperdal use is not enough to reverse the condition and surgery is required.
The condition is worse when Risperdal is given to adolescent males. A 2006 study published in the Journal of Clinical Psychopharmacology showed Risperdal use greatly increased prolactin levels in adolescents, which then triggered the development of breasts and for some, lactation.
Another study presented at the American Association for Geriatric Psychiatry's (AAGP) 2014 Annual Meeting showed males using Risperdal had a 69% higher risk of developing gynecomastia than non-users.
Risperdal might also cause:
• Hormonal changes
• Increased risk of Type 2 diabetes
• Increased appetite and weight gain
• Significant drowsiness
• Rash or hives
• Difficulty breathing and swallowing
• Involuntary movement
• Painful, long-lasting erections
• Difficulty walking
• Increased mortality in elderly users
There is also evidence Risperdal more than doubles the risk for adverse events in patients suffering from dementia. The medication is not approved for use in treating dementia, but is occasionally prescribed off-label by doctors for this purpose.
Numerous lawsuits have been filed against Johnson & Johnson and its subsidiaries in relation to Risperdal. One such lawsuit, filed by Shaquil Bird, states the plaintiff developed breast tissue and began lactating after his Risperdal use from 2001 to 2008. The problem was so severe, Bird required a mastectomy and continues to have psychological trauma because of his ordeal.
Bird's attorneys claim Risperdal manufacturers were aware of the dangers related to the drug, but concealed the information from doctors and patients. There are thousands of Risperdal lawsuits in progress across the United States with more than 650 active in the Philadelphia Court of Common Pleas, and several consolidated in multi-county legislation in New Jersey.
Lawsuits also claim the Johnson & Johnson and its subsidiaries failed to obtain FDA approval prior to promoting Risperdal for use in children and the company faces allegations of illegal marketing of its product throughout 36 states from 1993 to 2004.