Risperdal, marketed and manufactured by Johnson & Johnson, is an atypical anti-psychotic medication approved by the U.S. Food and Drug Administration (FDA) to treat specific mood disorders.

Currently, there is a lot of debate about the safety of the drug, as the use of Risperdal has been linked to gynecomastia, or the enlargement of male breast tissue that is seen in males, specifically young boys, taking the medication.

What is Risperdal?

Risperdal is an antipsychotic medication approved in 1994 by the FDA for the treatment of schizophrenia.  Risperdal works to block some of the receptors that in areas of the brain where too much stimulation can trigger psychotic and aggressive behavior.

Despite reports of Risperdal side effects being suffered by children subjected to off-label prescribing of the drug, Bipolar disorder was added as an approved treatment for adults and adolescents in 2002, in 2006 for autism spectrum disorders in children and for use in children with schizophrenia and bipolar disorder in 2007.

It has also been used “off-label” for the treatment of attention deficit disorder (ADD), schizoaffective disorder, anxiety, sleep disorders, and depressive disorders.  Off-label use means that the medication has not been approved for treatment of a specific disease and there is no research that has proven the medication safe; however physicians are allowed and routinely use medications for purposes other than that listed on the label.

Serious Adverse Events of Risperdal

Risperdal carries a number of side effects and interactions.  Though some of these side effects may be minor, some are severely damaging and may be permanent or even life-threatening.

One of the most alarming side effects of Risperdal is gynecomastia, the enlargement or development of breast tissue in males.  Risperdal male breast growth is more common and particularly disturbing in children and adolescents.

The impact of gynecomastia from Risperdal can have a serious impact on adolescent boys and leave them with long-lasting effects throughout the lifetime.

In addition to the physical injury caused by the development of breasts and the need for surgical removal in some cases, researchers have documented that adolescents or boys who develop breast tissue suffer not only physical changes but also severe emotional trauma.

Risperdal Controversy and Lawsuits

Risperdal has one of the longest histories of difficulties and disputes.  Problems with Risperdal use were noted as early as 2001 and litigation is still ongoing.  Johnson & Johnson has paid well over $5 billion in fines and settlements to date.

In 2012, Johnson & Johnson agree to settle for $181 million in suit by 36 states and District of Columbia regarding improper marketing of off-label uses for Risperdal, specifically the treatment of children.  The lawsuit also claimed that the company minimized Risperdal side effects.

Additionally, in 2012, Johnson & Johnson in an alleged attempt to avoid further investigation by the U.S. Department of Justice, paid a $2.2 billion fine with a provision that company would not admit to improper conduct.

Lawyers for plaintiffs who have filed Risperdal lawsuits have argued that Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals were not truthful and minimized concerns of Risperdal gynecomastia along with the improper use of illegal marketing promoting of off-label uses for Risperdal.

If you or a loved one suffered adverse side effects such as gynecomastia after taking Risperdal, you may be entitled to compensation for your pain and suffering.  A qualified Risperdal attorney may be able to assist you in regards to your claim.