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Johnson & Johnson's antipsychotic drug Risperdal made billions of dollars for the company, but it is linked to serious side effects like breast development in boys, movement disorders and diabetes.

risperdalRisperdal (risperidone) is a powerful second-generation antipsychotic approved for the treatment of schizophrenia and bipolar disorder in adults and adolescents, and autism spectrum disorders in children and adolescents. The drug is also used “off label” for attention deficit hyperactivity disorder (ADHD), anxiety, sleep difficulties and depression.

Risperdal was a huge moneymaker for Johnson & Johnson and its Janssen unit, with annual sales peaking at more than $4.5 billion in 2007. Profits declined once J&J lost patent protection, and the company reported only $358 million in name-brand sales in 2012.

Risperdal was first approved by the Food and Drug Administration (FDA) to treat schizophrenia in 1993.

The FDA later expanded its approved uses to include:
2003: Short-term treatment of bipolar I disorder in adults.
2006: Treatment of irritability associated with spectrum disorders in children and adolescents 5 to 16 years old.
2007: Schizophrenia in adolescents ages 13 to 17 and short-term treatment of bipolar I disorder in children and adolescents ages 10 to 17.

Following the blockbuster success of Risperdal, the manufacturers of Risperdal now face a multibillion-dollar government settlement that covers illegal marketing charges, as well as similar settlements with the states totaling nearly $2 billion. The problems stem from the companies’ marketing of Risperdal for off-label (unapproved) uses in children in the 1990s and early 2000s.

The drug was recalled twice. Two lots were recalled in 2011 because they were contaminated with chemicals used to treat shipment pallets. One lot of the injectable Risperdal Consta was recalled in 2013 because of mold concerns.

There are reports of serious side effects from Risperdal, including gynecomastia (breast development in boys), movement disorders and diabetes. J&J and Janssen have settled several gynecomastia personal injury lawsuits and face hundreds more.

How Risperdal Works

Risperdal comes as a tablet or liquid. It also comes in injectable form, sold as Risperdal Consta. Risperdal is meant to work on its own, but it may be combined with other medications like lithium or an antidepressant in the treatment of depression and bipolar disorder.

Risperdal works by targeting both serotonin and dopamine receptors in the brain. Serotonin and dopamine are neurotransmitters, chemicals released by nerve cells to send signals to other nerve cells. They help control feelings of happiness and reward. By blocking some of the receptors for these chemicals, Risperdal ensures that the chemicals have less of an effect on the mind, decreasing psychotic and aggressive behavior. It minimizes the so-called “positive” and “negative” symptoms of schizophrenia.

Risperdal is known as an “atypical” antipsychotic because it targets serotonin in addition to dopamine, which may be why it is more effective than traditional antipsychotics at reducing symptoms. Other atypical antipsychotics include Abilify (aripiprazole), Zyprexa (olanzapine), Seroquel (quetiapine fumarate) and Invega (paliperidone).

Side Effects

Unfortunately, what makes Risperdal work is also what can cause side effects. Risperdal works by altering the levels of dopamine and serotonin in the brain, but it can also cause a number of complications brought on by the abnormal levels of hormones in the body.

Risperdal is associated with serious side effects, including:
Breast Development in Boys. Gynecomastia is the enlargement of breast tissue in males, particularly adolescents. Risperdal greatly increases levels of prolactin, a hormone that stimulates production of milk in pregnant women. This increase may be one reason that boys taking Risperdal experience abnormal breast growth.
Movement Disorders. One of the most dangerous side effects of Risperdal is an increased risk of movement disorders  such as Extrapyramidal symptoms (EPS) and tardive dyskinesia. These movement disorders are characterized by involuntary and sometimes painful muscle movements. Another disorder, dystonia, also involves uncontrollable sounds.
Diabetes. Risperdal has been linked to Type 2 diabetes and high blood sugar.
Heart Problems and Death. All antipsychotics carry a risk of sudden cardiac death. The medication also carries a black-box warning for increased risk of death in older patients with dementia.
Risperdal has also been linked to the following more common side effects, according to the FDA:
Priapism (prolonged penile erection) Somnolence
Fatigue Insomnia
Sedation Akathisia (restlessness)
Vomiting Drooling
Abdominal pain Dizziness
Nausea Anxiety

Illegal Marketing of Risperdal

Although doctors may prescribe medications for “off-label” (unapproved) uses, the law prohibits companies from actively promoting or marketing drugs for such uses. One example of off-label use is when some doctors prescribe Risperdal as a treatment for ADHD.

A panel of federal drug experts found the risks of Risperdal too profound to justify its use in treating behavioral disorders in children, so use of the drug to treat ADHD and other behavioral disorders remains off-label despite approval of the drug for use in children’s schizophrenia and autism.

Government regulators and attorneys general for 36 states and the District of Columbia settled a lawsuit in August 2012 in which they claimed that Johnson & Johnson illegally promoted off-label use of the drug in children before the FDA approved it for younger patients. The charges included paying physicians to give favorable speeches, paying for golf outings for doctors and giving bonuses to salespeople who marketed the drug to pediatric doctors. Doctors who promoted Risperdal for children were also rewarded by the drugmaker with lucrative consulting deals, according to the lawsuit.

Johnson & Johnson was negotiating a  settlement with federal authorities over its aggressive marketing of Risperdal. The agreement originally stalled over language that the government wanted J&J to add acknowledging that it downplayed data on increased prolactin levels that stimulated breast development in children. Johnson & Johnson does not want to include that language because it fears the admission could be used in civil lawsuits. In 2013, the company finally agreed to pay $2.2 billion to settle the charges.

Risperdal Lawsuits & Settlements

Hundreds of individual lawsuits have been filed against Johnson & Johnson by patients who say they experienced humiliation and psychological trauma from breast growth resulting from the drug. The first of these lawsuits to be settled, in September 2012, was filed by Aron Banks, who suffered breast development as a boy while taking Risperdal from 2000 to 2004. His successful case may be a bellwether for the hundreds of other lawsuits that allege breast growth from Risperdal.

Several similar cases have been settled since then. As Johnson & Johnson faces billion-dollar penalties from federal and state agencies and new evidence emerges in those cases, more former patients are likely to file Risperdal lawsuits.

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