Risperdal

Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) developed the atypical antipsychotic Risperdal in 1993. It was originally FDA approved for the treatment of psychotic episodes brought on from schizophrenia (and the various subtypes). Since its development the drug has also been approved to help treat the symptoms of bipolar disorder, schizophrenia in youth, and irritability in autistic children. While the drug does help to suppress the dopamine and serotonin receptors in the patient’s brain, it may also lead to some unintended side effects, such as gynecomastia. These side effects have led to legal issues for Johnson & Johnson lately.

History of Risperdal

Until the 1990’s, Clozapine was the only atypical antipsychotic available (although rarely used due to the side effects). In 1993 Janssen Pharmaceuticals, which is owned by the parent company Johnson & Johnson, developed the drug risperidone, and Risperdal came on the scene.

For the first 10 years, Risperdal was hugely popular (and profitable) for the treatment of schizophrenia. And while the FDA had only approved the drug for the treatment of that one disease, many doctors were prescribing it for off-label conditions. Those taking the drug for conditions other than schizophrenia often saw an increase in the severe side effects.

In 2003 the drug was approved for treatment of bipolar disorder. In 2006 the FDA approved the drug for the treatment of irritability in children with autism. 2007 saw approval for the treatment of schizophrenia in children aged 10-17. This approval put Risperdal in the position as the only drug available to treat schizophrenic youth.

The Problem with Janssen’s Antipsychotics

Both Risperdal and Invega have a major problem: they can cause breast growth in males. To make matters worse, this severe side effect was never fully disclosed to the public before the drugs were approved by the FDA. This has led to a number of Janssen lawsuits.

Side Effects

Cerebrovascular

In 2003, Johnson & Johnson joined with the FDA to issue a warning letter concerning a heightened risk of cerebrovascular adverse events (such as stroke and transient ischemic attack) in elderly patients using the drug to treat dementia.

Hyperglycemia

The following year, the FDA issued another Risperdal warning letter, linking the drug to hyperglycemia which could evolve into Ketoacidosis, coma, diabetes mellitus, and death.

Gynecomastia

In male children and adolescents, Risperdal has been known to cause gynecomastia, which is the growth of breast tissue in males.

Other side effects may include:

Weight gain
Neuroleptic Malignant Syndrome (NMS)
Pituitary tumors
Heart attack
Heart arrhythmia
Tardive dyskinesia (involuntary movement)
Suicide
Cellulitis
Pancreatitis
Bone loss
Neutropenia
Death

Some of these conditions are very rare. However, some are common enough to be a big issue while taking the drug. One of those that has reared its head lately is gynecomastia, the development of breasts. Male youths are prone to this adverse side effect; the consequences can be long lasting.

Male youths that experience gynecomastia will notice that their breasts have become increasingly swollen, and may be painful to the touch. As the condition progresses, noticeable breast growth may occur. In some cases the breast growth results in galactorrhea, or the production of milk from the breasts.

While the enlargement of male breasts is not necessarily physically harmful, the result could have lasting effects on the psychological health of the patient. Low self-esteem and shaming can result, and when these are coupled with the underlying psychological issues that already exist, the results can be devastating to the patient’s mental well-being.

Risperdal Studies

New England Journal of Medicine

A study published in the New England Journal of Medicine (2005) gave some insight as to some of the adverse side effects that patients suffer when using atypical antipsychotic drugs. The study looked at nearly 1,500 patients. These patients were randomly assigned one of 5 different drugs for the treatment of their varying degrees of schizophrenia. The trial was to run a course of 18 months, during the time the patients would be monitored not only for the efficacy of the drug, but also to determine what side effects were truly being produced.

The results of the test were astounding to say the least. Out of the original group, 74% failed to complete the entire 18 month treatment due to discomfort brought on by adverse side effects. Of those who did complete the study, there were some serious side effects noted. For instance, in the group that was taking the drug Risperdal, 4% of them suffered from gynecomastia.

National Center for Biotechnology Information

The NEJM study only confirms what was discovered six years prior with the National Center for Biotechnology Information (NCBI). Their trial showed that patients taking risperidone (Risperdal) had an increased risk of hyperprolactinemia.

Hyperprolactinemia is a disorder where the body produces too much prolactin (a protein that enables milk production). One of the symptoms of this disorder is gynecomastia, or the growth of breasts (especially in males). The study found that the correlation between those taking Risperdal and those who developed the disorder was substantially higher than the control group.

There are many other studies out there that have come to the same conclusion: taking Risperdal is not as safe as it was originally described. This has led to lawsuits being brought against the drugs developer Janssen Pharmaceuticals (and the parent company Johnson & Johnson) claiming the manufacturer never fully tested the drug, and did not warn patients about the full possibility of the side effects.

Risperdal and Children

One of the biggest problems that results from the use of Risperdal by children is gynecomastia. Gynecomastia, or breast growth in males, is a common side effect of puberty. Nearly all adolescent males will experience minor breast growth to an extent. However, when a child is taking Risperdal, the body will produce elevated levels of the hormone prolactin. This hormone, which causes the breasts of new mothers to start producing milk, can initiate the growth of breasts in the patient. Male children taking Risperdal, who are already at risk of developing minor breast growth as a result of puberty, are more prone to suffering from gynecomastia. While physically developing breasts is not harmful, it can subject the patient to shaming, bullying, and shunning; all which may lead to lifelong psychological trauma. But breast growth in males is not the only problem children experience with this drug.

While gynecomastia is a severe side effect of taking Risperdal, it is not the only one that children experience. Many children on the drug also experience extreme weight gain. A study in 2002 found that 42.9% of the study group of adolescent youth had extreme weight gain (gained more than 7% of their body weight) after just 12 weeks on the drug.

Another study from 2008 found that even more serious side effects were present in patients taking Risperdal and other antipsychotics. In this study of several thousand children over a period of 10 years, it was determined that not only was obesity a side effect, but other problems that often accompany it. These children were at a higher risk of type 2 diabetes, and cardiovascular conditions.

Risperdal has been the focal point of a number of lawsuits lately regarding the manufacturer’s parent company, Johnson & Johnson, and how they marketed the drug. Overwhelming evidence is showing that children are at a higher risk of developing some of these serious side effects, because their bodies are going through puberty and changing already. While the drug does help treat the symptoms of schizophrenia, it also makes the body react in a negative way.

Risperdal Profits

Johnson & Johnson has seen billions of dollars from the sale of this one drug alone. It has helped them maintain their spot as the largest drug company in the world (with 2012 sales of over $67 billion). Risperdal alone has brought the company many billions of dollars ($4.5 billion just in 2007), and continues to bring substantial profits to this pharmaceutical giant. These profits came as a result of allegedly hiding the fact that the drug was known to cause adolescent males to develop breasts.

Risperdal Lawsuit

In 1999 Aaron Banks started using Risperdal at the age of 9. For the next five years he was on a regimen of the antipsychotic. At this point in time, Risperdal was not approved for use in minors; in fact, it was not approved for anyone under the age of 18 until 2003. As a result of using the drug, Aaron suffered from gynecomastia, that is, he grew female breasts. He would later require surgery to remove the breasts.

In 2012, at the age of 21, Aaron filed a lawsuit against Johnson & Johnson due to psychological trauma that he suffered during his youth from the shaming, bullying, and shunning that resulted from being a boy with breasts. Rather than defend their drug, Johnson & Johnson did something unheard of: they settled on the first day of trials. This settlement resulted in the company paying as much as $2.2 billion.

Banks’ lawsuit was not the only one Johnson & Johnson were being faced with. The company had just agreed to pay $181 million to plaintiffs in 36 states regarding misleading advertisement for Risperdal and Invega for off-label uses (treatment of disorders not approved by the FDA). In April of 2012 a judge in Arkansas found the company to be in violation of misleading advertising. A South Carolina judge found the same thing in June 2011. While Aaron Banks’ case was the most popular, it certainly was not the first or the last.