Risperdal (risperidone) is an antipsychotic approved by the Food and Drug Administration in 1993 for the treatment of schizophrenia in adults. In 2006 and 2007, the FDA approved additional uses for Risperdal including schizophrenia in children, bipolar disorder in adults and children and behavioral disorders caused by autism in children.
Prior to availability of risperidone, Risperdal was the number one antipsychotic used in the US and had yearly sales of over $4.5 million. Today, the Risperdal franchise, including a related medication Invega (paloperidone) continues to have combined sales of over $3 billion per year and Risperdal is estimated to have made about $40 billion for its maker Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson which is the largest pharmaceutical and health products manufacturer of the world with a yearly income of approximately $71 billion.
Since shortly after its approval, reports of serious issues with Risperdal effects and the inappropriate marketing of Risperdal began to surface. To date, the manufacturers of Risperdal have paid $billions in criminal penalties, fines and lawsuit settlements for a variety of reasons including injury to patients.
Serious Adverse Events of Risperdal
Breast Development in Boys
Gynecomastia is enlargement or development of breast tissue in males. It is more common and particularly disturbing in children and adolescents. The development of gynecomastia is usually a permanent change that will require surgical removal by a reconstructive surgeon. Gynecomastia has been attributed to Risperdal’s stimulation of prolactin, a hormone common in women who are pregnant or nursing. Adolescents or boys who develop breast tissue suffer not only physical changes but also severe emotional trauma.
Risperdal events, FDA actions and lawsuits
Risperdal has one of the longest histories of difficulties and disputes of any medication on the market and at its peak, Risperdal was the most common antipsychotic used in the US. Marketing abnormalities including inappropriate marketing for unapproved uses in children and adults and for other indications such as ADHD, chemical restraint and schizoaffective disorder has been reported as far back as 1994, shortly after the medication was approved to treat Schizophrenia. Harm caused by Risperdal use was noted as early 2001 and litigation is still ongoing. The company has paid well over $5 billion in fines and settlements to date.
Risperdal Lawsuits and Other Actions
Risperdal received approval in 1993 as the first drug of the new category, atypical antipsychotics. By 1996, over one million prescriptions for the medication had been written, including many for unapproved, off-label uses. As early as 1999, reports began to surface regarding problems with Risperdal use in children which was not an approved use.
Physicians may use medications for off-label reasons if they feel the patient will benefit, however the manufacturer is not allowed to promote medications for unapproved indications. Janssen and the parent company, Johnson & Johnson have been shown to have improperly marketed the medication for unapproved uses.
In 2001, the Miami Herald reported cases of Risperdal side effects including gynecomastia development in juvenile males in the Florida foster care system who had been given the medication as a pharmaceutical “restraint”, a problem which had been suspected for at least two years.
In 2002, Janssen Pharmaceuticals issued a warning letter to Canadian practitioners regarding risks in the elderly dementia population but did not warn US practitioners until the following year. Risperdal is responsible for at least 37 cases of stroke type events including 16 deaths. A black box warning (the most severe warning a medication can have) was required in 2005 by the FDA to be included on labeling of Risperdal and other antipsychotics warning practitioners of the dangers of Risperdal in elderly patients with dementia.
Risperdal was approved for the treatment of irritability in autism in children in 2006 and the same year a clinical study performed at Duke University showed that the drug was associated with gynecomastia (male breast tissue development) and that premature breast development may occur in girls. Risperdal was also shown to cause lactation in girls, boys with gynecomastia and in women who were not pregnant or nursing.
Despite this knowledge, the FDA approved Risperdal for the treatment of schizophrenia in children and bipolar disorder in both children and adults in 2007. The following year, the Wall Street Journal reported that Risperdal had been shown to increase prolactin levels (leading to breast development and lactation) and experts stated that up to 70 percent of gynecomastia childhood events were found to be caused by Risperdal use.
Serious adverse event reports of Risperdal use in children numbered over 1200, including 31 deaths between 1999 and 2008, however a 2008 FDA advisory meeting concluded that warnings did not need to be strengthened on Risperdal labeling. Since then, several lots of Risperdal have been recalled due to chemical contamination.
The first lawsuit regarding harm caused by Risperdal use was filed in 2010 by a 21 year-old man who had taken Risperdal for off-label use between 1999 and 2004 and suffered physical and emotional trauma due to gynecomastia or the development of male breasts. In 2012, the case was settled by Johnson & Johnson on the first day of trial for an undisclosed amount, prior to the plaintiff’s attorney calling a former company CEO as a witness.
The same year, Johnson & Johnson was accused of improper marketing practices and was fined $1.2 billion in an Arkansas federal court due to claims that they downplayed risks and that over 240,000 cases of Medicaid fraud and 4,500 deceptive practices had been caused by the manufacturers marketing activity.
Also in 2012 the company settled lawsuits with 36 states and the District of Columbia regarding improper marketing techniques, specifically for the treatment of children. The cases were settled by the payment of $181 million. Other state cases had also been settled including $327 million in South Carolina, $258 million in Louisiana and $158 million in Texas.
During 2012, Bloomberg News reported of over 420 additional lawsuits including over 100 which were related to gynecomastia and the company’s failure to adequately warn of the risk. Six gynecomastia suits were settled for undisclosed amounts before the FDA Commissioner could be called as a witness.
The company paid $2.2 billion in fines and penalties to the US Department of Justice in 2013 to avoid prosecution related to misbranding of Risperdal, which is the largest settlement of its type. Janssen Pharmaceuticals and the parent company Johnson & Johnson are still under investigation and continue to face hundreds of lawsuits regarding serious and life-threatening events caused by Risperdal.
Attorneys for the victims have claimed that Johnson & Johnson and its subsidiary, Janssen used illegal marketing to promote Risperdal for unapproved uses even after they were aware of the threats of gynecomastia, movement disorders and the risk of death and that they minimized and did not adequately warn of those risks.