Risperdal Lawsuit

Risperidone (Risperdal) is an antipsychotic drug used to treat conditions like bipolar disorder and schizophrenia, as well as symptoms of violence and aggression in autism. This powerful drug is also being used in alarming numbers in children with ADHD, which is clearly an off label use of the drug. In other words, Risperdal has never been approved by the FDA for use of conditions like ADHD, therefore, using it in this way is considered “off label.” Other off label uses include prescriptions to elderly patients for dementia and as an augmentation strategy for depression and anxiety disorders.

In fact, the trend in prescribing antipsychotics for off labels use has been increasing at an alarming rate over the years, and this in spite of the lack of evidence that they are any more effective in treating the conditions they are being prescribed for than traditional medications that have fewer (and less dangerous) side effects.

Antipsychotics like Risperidone commonly come with a host of side effects and should not be used lightly regardless of the condition it is used for or whether the FDA has approved its use in the general public or not. Some of the side effects include:

• Somnolence
• Anxiety
• Upset stomach
• Extrapyramidal symptoms (EPS)
• Nausea and Vomiting
• Diarrhea
• Abdominal pain
• Tremors
• Blurred vision
• Diabetes
• Stroke
• Seizures
• Painful erection (priapism)
• Neuroleptic malignant syndrome
• Tardive dyskinesia
• Hyperprolactinemia
• Constipation
• Weight gain
• Dizziness
• Rash

Consumers cannot assume a drug’s safety simply because a drug company reports that clinical trials have been conducted or that it has received permission to market its product. 

What You Should Know About the Clinical Trial Process

Before a drug can be released for public use, a carefully controlled clinical trial should be conducted in order to ensure that the benefits of taking the drug outweigh the risks involved in its use. There are several steps (phases) that must be followed in a well-designed study protocol where researchers gather data and then establish the necessary safety profile for each drug. In order to do this, a representative and adequate sample size (in other words, plenty of people in your study who are similar to those who will be taking the drug for the condition you are hoping to treat) is needed. The main problem clinical trials face is:

• Small, inadequate sample size
• Limited age range
• Generally healthy volunteers
• Study subjects are typically not allowed to take any other drugs except the one being tested
• Long-term effects of the drug are often not observed
• Drugs and their effects are seen under most favorable and controlled conditions

While some of these may certainly be necessary conditions for initial testing of the drug, once the drug is distributed to the population at large – who obviously will not fit the above criteria – problems inevitably begin to surface. Why the drug companies refuse to wait until safety can be established is clearly a matter of money; these trials themselves can cost an incredible amount to conduct, and they want to recoup their costs as quickly as possible. It is also the reason they are willing to make more of their findings than they legitimately should.

Apparently, these are risks that the drug companies are willing to take with your health, and for good reason: between 2003 and 2012 alone the top 11 pharmaceutical companies earned a net profit of over $711 billion – $85 billion in 2012 alone. These companies are spending millions on marketing and advertising, especially to the doctors who are prescribing these drugs, but are reaping billions for their efforts, despite the deadly risks their drugs carry. They are also willing to invent new uses for old drugs in order to keep them on the market either by giving them new names or by finding “new” conditions for them to treat. The fact that lawsuits are being filed against them for the horrific side effects doesn’t stop them, either.

Risperdal Black Box Warnings and Lawsuits

Since its approval by the FDA in 1995, controversy has surround the use of Risperidone. In 2005, the FDA required that Black Box Warnings be included in packaging when a study showed that the death rate in elderly patients who used Risperdal was 1.7 times higher than those who had taken the placebo. Black Box Warnings are the strictest put on prescription drugs required by the FDA.

In 2006, a study by Duke University revealed that the use of Risperdal could lead to a condition called gynecomastia, or breast growth in males, and a 2008 study showed how it led to the production of prolactin in males, the hormone responsible for breast milk production. It is no surprise that some 70% of young males needing mastectomies have been victims of gynecomastia resulting from the use of antipsychotic drugs like Risperdal. Despite these and other studies showing serious adverse effects related to Risperdal use, this drug continues to be prescribed to children and elderly patients, young men have required mastectomies, and the FDA has refused to issue stronger warnings about its dangers.

In 2010, claims that Johnson & Johnson paid $50 million in kickbacks to a pharmaceutical supply company to market their drug to nursing homes between 1999 and 2004 were made in a government lawsuit. In 2011, a suit against the company for not disclosing serious side effects such as diabetes were also brought (among others), and in 2012, Johnson & Johnson was fined $1.2 billion for downplaying the multiple risks associated with Risperdal. The case went back and forth in court and was eventually settled for $2.2 billion.

What About Side Effects?

When it comes to actual benefits (or not), many of these studies are not being released to the public, or are being glossed over so that results fall more favorably on the marketing side of things, so it is difficult to tell how much benefit outweighs cost in the case of Risperdal and just who should be exposed to such risks. The problem of bias is huge, as many of these trials are funded by the drug companies themselves. Of even greater concern is when the FDA admits to a clear conflict of interest when it comes to approving certain drugs or devices for public use.

As for the side effects of these drugs, the most common include drowsiness, dry mouth, constipation, weight changes (usually weight gain), headache, cough, runny or stuffy nose, headache, nausea, and abdominal distress, to name a few. There are more serious side effects of course, some of which can be permanent and have life-long implications.

Antipsychotics can cause serious reactions called extra pyramidal side effects (EPS) that include conditions referred to as tardive dyskinesia, Parkinsonism, and akathisia. Symptoms such as drooling, muscle twitching, and other motor tics can occur (among others) with the use of these drugs. While some symptoms may abate when medication is stopped, these side effects can be permanent.

EPS are dystonic (muscle control) reactions (intermittent spasms or involuntary contractions of the face, neck, or other muscles in the body) associated with antipsychotic drug use. Tardive dyskinesia (TD) is a serious side effect of antipsychotics like Risperdal and involves involuntary, repetitive body movements like protruding tongue, sucking motions, and other uncontrolled facial movements. Parkinsonism (muscular stiffness, tremors, and the inability to control one’s muscle movements) can also result from the use of these drugs. Some report restlessness in the limbs (akathisia) that is characterized by quivering muscles and tend to be highest among young males.

Specifically, some less common, but severe and permanent side effects have also been reported from the use of Risperidone, a commonly prescribed antipsychotic. One of the most troubling has been gynecomastia, the development of breast tissue in males. This condition is permanent, even if the drug is stopped. Symptoms include pain and tenderness in one or both breasts that may begin as a nodule on the nipple. There may be discharge from the nipples, and breast development may be uneven and lopsided. The only way to deal with the excess tissue is surgical removal of the breast growth, leaving lifelong scars.

Needless to say, the emotional damage to a young male can be devastating, and the trauma experienced by children and adolescents with this condition can last well into adulthood. Adolescent gynecomastia occurs in the most difficult period of life for a young man, as the proper estrogen to testosterone levels are interrupted increasing their distress. One study found that males with this condition showed significantly elevated levels of depression, anxiety, and social phobia compared to controls, threatening both self-esteem and sexual identity.

Another serious side effect of Risperdal is the production of pituitary tumors. Because this drugs acts on the pituitary gland and increases prolactin levels, the gland may grow in size, interrupting normal hormone production, leading to serious potential health concerns that include vision problems, internal bleeding, headaches, and convulsions.

Type II diabetes is also a concern with Risperdal use as elevated blood sugar levels rise. Studies have shown a much higher incidence of Type II diabetes in patients who are administered antipsychotics, therefore blood glucose levels need to be monitored regularly. Problems with extremely high glucose levels can lead to coma and even death.

Further, this drug has been shown to be unsafe in elderly populations, leading to stroke, kidney damage, low blood pressure risks, and a higher incident of death due to pneumonia and heart attack. For pregnant women, the concern is also high, as antipsychotics like Risperdal have been shown to cause birth defects, premature birth, newborn respiratory distress, and even withdrawal in newborn infants.

Why children are prescribed this drug at all is a mystery, particularly when research shows that far too many of them are being given Risperdal for conditions that are related to behavior and not psychosis. The risk for Type II diabetes triples in children in the first year for those who use this drug, and like gynecomastia, the weight gain and metabolic disorders can lead to life-long problems.

While antipsychotics certainly have their place in the treatment of serious mental disorders, too many doctors are prescribing these drugs for other conditions when they should be a last line of defense and not needlessly given to those who do not absolutely require their use.

False claims and deceptive marketing concerning Risperdal