San Jose, CA- There is an anti-psychotic drug “Risperdal” that is manufactured by Johnson and Johnson (J & J). The Food and Drug Administration (FDA) approved the drug for adults in 1993 for the treatment of schizophrenia. Then the drug was approved in 2003 to include treatment of Bipolar I disorder in adults. Later in 2006 Risperdal was approved for treatment of irritability associated with autism in children from ages 5 to 16. Then approval was obtained in 2007 for children age 10 and up for treatment of schizophrenia and Bipolar I disorder, as it is used for adults.
Prolactin is the hormone that is released in the pituitary gland and is responsible for breast development and milk production in women. High levels of prolactin decrease the level of estrogen in women, and testosterone in men. It has been noted that Risperdal elevates prolactin which can cause breast growth, breast budding, gynecomastia also known as male breasts or moobs, and even production of milk in young girls, boys and adult men. Some studies showed the elevation of prolactin as soon as eight weeks of being on Risperdal.
Only approved uses for drugs are allowed to be promoted by the manufacturer under federal law. The term “off label” means using a drug for other than approved uses. Allegations have been made that the manufacturer of Risperdal had encouraged “off label” use to treat such conditions as attention-deficit/hyperactivity disorder (ADHD), obsessive-compulsive disorder (OCD), oppositional-defiant disorder (ODD), conduct disorder (CD), disruptive behavior disorder (DBD), Tourette’s syndrome, post-traumatic stress disorder (PTSD), and pervasive development disorder (PDD).
J & J is facing several lawsuits due to the fact that the FDA only gave limited approval for use of Risperdal in children. Some cases are still pending, and others have settled such as; Texas in January 2012 was awarded $158 million for fraudulent marketing and $181 million awarded to 36 US states for promoting non-approved uses including dementia, anger management and anxiety. The largest settlement made last year of 2.2 billion is on hold as J & J is negotiating to avoid wording in the agreement that may leave them vulnerable to private lawsuits.
An attorney that represents many of the harmed patients also filed a petition with the FDA on July 27, 2012 on behalf of his clients; he is hoping to get the drug banned for use in children until long term safety can be determined. He also wants J & J to immediately put a “black box” warning on the label to alert patients, parents and their prescribing physicians to the possible development of gynecomastia.
The petition also addresses the fact that many times health care professionals prescribe medications without performing regular physical examinations for young boys and young men with attention to abnormal breast growth, testicular development and sexual maturation. Most parents do not know what gynecomastia is and would not know to be on the lookout for abnormal breast growth in their son without specific warning.
Besides the possible development of male breasts, Risperdal may cause significant weight gain, thus affecting the adolescent’s endocrine system. With the label warning greatly understating the risk of weight gain, the treating physician may attribute the development of gynecomastia breasts to over nutrition or puberty. Sadly with the continuation of Risperdal, gynecomastia may become a permanent condition that will only be resolved by gynecomastia surgery.
Gynecomastia may be the result of many different drugs, but there is not a known drug that will reverse the condition. For all males suffering with the effects of gynecomastia, a consultation with a Board Certified Plastic Surgeon that specializes in male breast reduction is highly advised.