Risperdal and Diabetes
Risperdal (risperidone) is an antipsychotic drug used to treat bipolar disorder and schizophrenia in adults. It has also been used to treat irritability in children diagnosed with autism. Some doctors have also used the drug “off label” to treat conditions like obsessive-compulsive disorder, ADHD and Tourette syndrome – in children as well as adults.
The drug was approved by the FDA in 1993 and quickly became a top seller for Ortho-McNeil-Janssen, a subsidiary of Johnson & Johnson. However, it wasn’t long before concerns arose over some of the potentially serious risks associated with Risperdal.
The more severe side effects of Risperdal include gynecomastia (abnormal breast growth) in male users, type 2 diabetes and movement disorders. Type 2 diabetes has been linked to Risperdal use through research studies for more than a decade. In 2008, physicians raised concerns to the FDA about the drug and some types of side effects, including type 2 diabetes. However, the agency has not yet acted on those concerns to warn the medical community or require an update to the drug’s label.
Risperdal and diabetes
Type 2 diabetes is a condition that occurs when the body does not use insulin properly to control blood sugar levels. In the early stages, the pancreas tries to make additional insulin to make up for the deficit. However, the pancreas is eventually no longer able to keep up with the demands of the body. In some cases, the pancreas does produce sufficient insulin levels, but the body resists its effects and symptoms begin to develop.
The symptoms of type 2 diabetes include:
- Frequent thirst and urination
- Blurred vision
- Tingling in the hands and feet
- Severe fatigue
- Weight loss, even as the appetite increases
- Slower healing of infections or wounds
Type 2 diabetes can be treated through lifestyle changes and medication. However, there is no “cure” for the disease and many patients diagnosed with type 2 diabetes are at high risk for potentially serious complications.
Some of the complications frequently seen with type 2 diabetes include:
- Hearing impairment
- Kidney damage
- Cardiovascular disease
- Eye damage and blindness
- Nerve damage
- Damage to the foot
Many of these complications can be debilitating or life-threatening, greatly impacting the individual’s quality of life. Patients with the condition must be very committed to managing the disease over a lifetime to reduce the risk or delay complications associated. Unfortunately, even patients that are careful to manage their disease properly may still be faced with serious complications in the future.
Research on Risperdal diabetes link
A number of studies have supported the risperidone diabetes association:
- One study, reported by the New York Times in 2003, looked at more than 19,000 veterans treated with both older and newer antipsychotic drugs. Researchers in this study found that three of these drugs, including Risperdal, had a much higher risk of type 2 diabetes than the older drugs prescribed. The highest risk was seen in patients under the age of 54 that took Risperdal or another second-generation drug, Zyprexa.
- Another study, published in the American Journal of Epidemiology, showed an increased risk of diabetes in patients that used the second-generation drugs instead of older antipsychotic medications. Researchers from the University of Illinois at Chicago found that patients that took new drugs had a 60-70% higher risk of diabetes than those that took older drugs like haloperidol. The risk was highest in younger patients that had been diagnosed with schizophrenia.
- A third study, published in Pediatrics in 2011, indicated a fourfold risk of diabetes in children that took second-generation antipsychotic drugs over children that did not take any medication. Researchers looked at more than 9,000 pediatric subjects between the ages of five and 18. This report specifically states that “given the clinical complications associated with diabetes, the potentially increased risk of diabetes with these agents in the pediatric population is an important drug safety and public health issue.”
- A study published in Pharmacotherapy in 2003 indicated a link between Risperdal use and hyperglycemia (elevated blood glucose levels). Researchers of this study looked at 131 test subjects and found that treatment with an atypical antipsychotic drug increased the risk of hyperglycemia. Most patients developed hyperglycemia within three months of the start of the medication.
Although numerous studies have shown a Risperdal diabetes link, researchers are not sure exactly how use of the drug can lead to a diabetes diagnosis. Some have theorized that because the drug can cause significant weight gain, this factor alone could lead to a higher incidence of type 2 diabetes. This form of diabetes has been linked to weight gain and obesity in the past.
Risperdal diabetes lawsuits
In 2012, hundreds of lawsuits were filed against Janssen involving Risperdal use and gynecomastia. Risperdal diabetes lawsuits are also beginning to grow nationwide, as more individuals who have been diagnosed with the condition come forward. Plaintiffs in these lawsuits are claiming Janssen did not properly warn Risperdal users of the elevated risk of diabetes, even though studies have indicated this association.
The allegations go beyond failure to warn for Janssen and Johnson & Johnson. Last year, an Arkansas judge fined the companies more than $1 billion, after a jury determined they hid risks associated with their drug from the FDA, medical community and general public. Jurors ruled on 10 questions posed before them – 5 involving Janssen and five involving Johnson & Johnson. The jury ruled in favor of the state on all 10 questions.
The judge overseeing the case, Judge Tim Fox, found 240,000 violations under the state’s Medicaid-fraud law. Each of those violations was assessed a $5,000 fine. In addition, Judge Fox issued an additional fine of $11 million, when he ruled in favor of an additional 4,500 violations under Arkansas deceptive trade practices act.
Similar fines and court awards have been issued against Johnson & Johnson in Louisiana, Texas and South Carolina:
- A jury in Louisiana ordered the company to pay $257.7 million to the state for Medicaid fraud and misleading regulators
- The company reached a $158 million settlement in Texas shortly after the decision in Arkansas
- South Carolina was awarded $327 million by a jury over claims the company overstated the safety of their drug in a marketing letter to doctors
Also in 2012, Johnson & Johnson agreed to a fraud settlement totaling $181 million. The Risperdal settlement involved 32 states across the country, as well as the District of Columbia. The company was accused of marketing the drug for off-label purposes, including treatment of bipolar disorder in children and teens.
Although doctors are allowed to prescribe drugs “off-label,” companies are prohibited from marketing their products for these purposes. In all of these cases, Johnson & Johnson continues to deny wrongdoing. However, more Risperdal lawsuits and possible settlements are anticipated in the future.
- Bloomberg, J&J Hid 3 Risperdal Diabetes Studies from FDA, Texas Jury Told, http://www.bloomberg.com/news/2012-01-19/j-j-hid-risperdal-diabetes-studies-from-fda-witness-testifies.html
- New York Times, 3 Schizophrenia Drugs may Raise Diabetes Risk, Study Says, http://www.nytimes.com/2003/08/25/us/3-schizophrenia-drugs-may-raise-diabetes-risk-study-says.html
- eMedTV, Risperdal and Diabetes, http://schizophrenia.emedtv.com/risperdal/risperdal-and-diabetes.html
- FDA, Warning Letter, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm055315.pdf
- Huffington Post, Johnson & Johnson Subsidiary Hid Risks Associated with Risperdal, Drug that Made Company Billions, http://www.huffingtonpost.com/2012/04/11/johnson-johnson-risperdal-risks_n_1417999.html
- CBS News, Ark. Judge Fines Johnson & Johnson More than $1.1 Billion in Risperdal Case, http://www.cbsnews.com/8301-204_162-57412418/ark-judge-fines-johnson-johnson-more-than-$1.1b-in-risperdal-case/
- American Journal of Epidemiology, Diabetes Risk Associated with Use of Quetiapine, and Risperidone in Veterans Health Administration Patients with Schizophrenia, http://aje.oxfordjournals.org/content/164/7/672.long
- Pediatrics, Antipsychotic Medication Use Among Children and Risk of Diabetes Mellitus, http://pediatrics.aappublications.org/content/128/6/1135.full
- American Diabetes Association, Type 2 diabetes, http://www.diabetes.org/diabetes-basics/type-2/
- Mayo Clinic, Type 2 Diabetes, http://www.mayoclinic.com/health/type-2-diabetes/DS00585