On July 24, 2006, Mississippi became the fifth state to file a lawsuit against Eli Lilly and Co. for its sales and marketing of Zyprexa (olanzapine).
The lawsuit was filed in Lafayette County Circuit Court. According to a special attorney general who is handling the case, the lawsuit was filed to recover money the state of Mississippi spent purchasing Zyprexa for the treatment of symptoms for which Zyprexa had not been approved.
Additionally, the state is looking to regain money spent treating Medicaid recipients who suffered injury or illness, including diabetes, after taking the drug.
Eli Lilly initially obtained FDA approval of Zyprexa to treat patients who were diagnosed with schizophrenia or bipolar disorder. However, the lawsuit alleges that after obtaining the approval, Eli Lilly then instructed its sales force to convince physicians to prescribe the drug for other problems such as mood, thought, and behavioral disturbances. These problems, such as anxiousness, mood swings, and irritability, were excluded from payment under the Mississippi Medicaid Prescription Drug Program. By convincing physicians to prescribe Zyprexa for unapproved use, Eli Lilly avoided the expense and delay of applying to have Zyprexa approved for such problems.
The lawsuit also claims that Eli Lilly knew that taking Zyprexa increased a patient's risk of contracting diabetes but did not warn the United States about this risk for nearly a year and a half. In April 2002, the company changed Zyprexa's labels in two countries, the United Kingdom and Japan. These changes included warnings that there was an association between Zyprexa and diabetes-related injuries.
A letter published by the Journal of the American Medical Association (November 28, 2001) claims that patients taking olanzapine (Zyprexa) were 10 times more likely to develop diabetes than members of the general population.
In addition to a $1 billion dollar settlement from 2005, Eli Lilly is contending with 5,500 claims in the United States and 5 class action lawsuits in Canada.
The four other states to sue Eli Lilly on behalf of consumers of Zyprexa are Louisiana (December, 2004), Florida (June, 2005), and Alaska and West Viginia (2006).
Zyprexa and Children
Zyprexa was originally approved for schizophrenia, and later for bi-polar disorder in adults. However, the drug has been shown to produce diabetes, hyperglycemia, and in some cases, death. Those who appear to be most at risk are children and young adults.
A recent article by USA Today (May 1, 2006) argues that atypical antipsychotics such as Zyprexa are being over prescribed to young people even though they carry serious side effects and the reports of deaths and dangerous side effects are mounting. According to a USA TODAY study of FDA data collected from 2000 to 2004, there were "at least 45 deaths of children in which an atypical antipsychotic was listed in the FDA database as the 'primary suspect'". Included in these deaths were at least six that were related to diabetes. Further causes of death included liver failure, heart problems, and pulmonary problems.
In addition to the deaths, USA Today found 1, 328 reports of negative side effects, some of which were life-threatening.
In spite of these alarming side effects, the number of children who received prescriptions for atypical antipsychotics, including Zyprexa, rose 80% between 2001 and 2005, according to USA Today. A study done for USA Today by Medco (sampling 2.5 million of Medco's members) showed that in 2001 the number of children 19 and under with at least one atypical prescription was 3.6 per 1,000. By 2005 that number jumped to 6.5 per 1,000.
Atypical antipsychotics are a new generation of drug that has been approved by the FDA for adult schizophrenia and bipolar disorder. Of the six atypical antipsychotics, including Zyprexa, none have been approved for children. However, doctors are able to prescribe them as "off-label" medications.