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Zyprexa Lawsuit

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Zyprexa Lawsuit

For over two decades, Zyprexa has been prescribed to millions of people as a safer and more effective way to treat psychotic disorders such as schizophrenia and bipolar disorder. However, mounting research suggests it is not as safe as consumers were lead to believe.

As a result, thousands of victims of Zyprexa’s unexpected side effects have filed lawsuits against drugmaker Eli Lilly and Company, and since 2006 the pharmaceutical company has paid out billions of dollars in settlements to users and the Department of Justice.

What is Zyprexa?

Zyprexa is an antipsychotic medication used to treat symptoms of schizophrenia and bipolar disorder. It belongs to a class of drugs called atypical antipsychotics, also known as second-generation antipsychotics (SGAs).

The active ingredient of Zyprexa is a generic drug called olanzapine. It is thought to function by rebalancing the dopamine and serotonin levels in the brain, both of which play a role in affecting mood, behavior, and thinking. In psychotic illnesses there may be an overproduction of dopamine in the brain, which may cause delusions and hallucinations. Blocking or limiting receptors from receiving dopamine signals seems to help relieve the symptoms of schizophrenia and mania.

Zyprexa comes in three forms and is usually taken once per day with or without food. Patients are typically started at lower doses before a gradual increase over several weeks. Oral doses range from 5 mg to 20 mg. Injections can have larger doses and work for longer periods of time.

History of Zyprexa

First-generation antipsychotics were first developed back in the 1950s. While initially promising, studies found that patients taking the drugs sometimes suffered severe long-term side effects like coordination problems.

Researchers eventually developed second-generation antipsychotics in the 1980s, and by 1989 released the first atypical antipsychotic. In 1996 the U.S. Food and Drug Administration approved another atypical antipsychotic called Zyprexa. At the time the FDA and its European counterpart, the European Medicines Agency,1 found that the benefits of Zyprexa were greater than the risks.

The drug quickly grew in popularity, bringing in $4.28 billion in sales by 2003. The FDA also expanded its approved uses of Zyprexa in 2004 to treat acute manic episodes and bipolar disorder. Between 1996 and 2009, sales topped $39 billion.2

In 2011 Eli Lilly lost its patent for Zyprexa, and the first generic version of olanzapine was approved3 by the FDA in October of that year.

Zyprexa Side Effects

Common Zyprexa Side Effects

These are some of the more prevalent Zyprexa side effects:4

  • Headache
  • Sedation
  • Weight gain
  • Cough
  • Diarrhea
  • Back pain
  • Nausea
  • Somnolence
  • Dry mouth
  • Increased appetite
  • Vomiting
  • Cold

Serious Zyprexa Side Effects

These are some of the more serious adverse reactions associated with Zyprexa:

  • Ketoacidosis (diabetic coma)
  • Neuroleptic malignant syndrome
  • Hyperglycemia
  • Gynecomastia (enlarged breasts in males)
  • Heart disease
  • Allergic reactions
  • Pancreatitis
  • Tardive Dyskinesia (uncontrollable movements)
  • High cholesterol

Zyprexa Reviews

Websites often allow users to post reviews of their experience taking prescription drugs. Zyprexa’s results have been mixed, but one of the more common negative complaints is weight gain. For example, on Drugs.com user kestrel28 wrote:5

“I started taking Zyprexa over two years ago for intrusive thoughts I was having as a result of Obsessive compulsive disorder/depression. While the Zyprexa helped remove intrusive thinking, it added about thirty pounds onto my slender frame, made me severely tired, and took away my sex drive. In addition to these adverse effects, I was unmotivated/uninterested in many activities that used to give me pleasure. I had a “so what” attitude about life in general. All because of this medicine. What really frightened me about taking this was my cholesterol went sky high, and my blood sugar was also very high, making me an at risk candidate for diabetes. I am finally off of this.”

Zyprexa Hid Risks of Side Effects

Since the drug was first approved, researchers and users have been wary of possible side effects of the drug, including weight gain and diabetes.

In 2003, the FDA warned that second-generation antipsychotic drugs could cause high blood sugar, but never specifically mentioned Zyprexa. However, a label warning was added in 2004 regarding an increased risk of diabetes. More reports and news pieces about the dangers of Zyprexa and its link to diabetes appeared in the following years, forcing the company to finally address the issue.

Then, in 2007, Eli Lilly added strong warnings6 about weight gain, high blood sugar, high cholesterol, and other issues to the drug’s label. Before then, the company had been resistant about connecting Zyprexa to weight gain and blood sugar increases, and had also downplayed weight gain risks over the years. In fact, documents received by The New York Times7 in 2006 indicated that Eli Lilly was aware of Zyprexa’s links to obesity and high blood sugar as early as 1999. In emails, doctors within the company warned that the risk factors for diabetes associated with Zyprexa were a “major threat to the long-term effect” of the drug. These internal warnings continued over the next two years.

Most recently, in 2016, the FDA issued a safety communication8 warning about a rare but serious skin reaction to drugs containing olanzapine. The severe condition called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) can result in injury to organs and death.

Thousands File Zyprexa Lawsuits & Settle

As a result of unexpected side effects like diabetes, thousands of lawsuits were filed against Eli Lilly. Plaintiffs claimed that the pharmaceutical company downplayed risks about side effects and hid information from the public in pursuit of profits. In 2006 and 2007, hastened by the The New York Times story, Eli Lilly agreed9 to pay about $1.2 billion to settle more than 28,000 personal injury lawsuits.

Eli Lilly Pays $1.4 Billion in Settlement for Off-Label Marketing

In 2009, Eli Lilly was the target of a federal lawsuit over allegations that the company illegally marketed Zyprexa to elderly patients with dementia. Eli Lilly agreed to pay $1.4 billion to resolve criminal and civil lawsuits with the federal government and several states.

“Off-label promotion of pharmaceutical drugs is a serious crime because it undermines the FDA’s role in protecting the American public by determining that a drug is safe and effective for a particular use before it is marketed,” said Gregory G. Katsas, Assistant Attorney General for the Civil Division, in a statement.10

Zyprexa carries greater risks for elderly patients with dementia, including a higher risk of premature death.

Victims Continue Coming Forward with Lawsuits

Despite the billions of dollars used to settle lawsuits from the public as well as claims made by the government, Eli Lilly continues to come under fire for Zyprexa.

With recent updates about the risk of serious skin conditions caused by Zyprexa, it is possible more people will continue to file lawsuits related to the drug. Those who have been injured by Zyprexa are encouraged to contact an attorney to find out how to participate in a settlement or pursue litigation against Eli Lilly.

References

  1. Drugs.com. “ Zyprexa ”, Drugs.com, https://www.drugs.com/uk/zyprexa.html. Accessed April 12, 2018.
  2. Gardiner Harris, Alex Berenson. “Lilly Said to Be Near $1.4 Billion U.S. Settlement”, NYTimes.com, https://www.nytimes.com/2009/01/15/business/15drug.html. Accessed April 12, 2018
  3. Bill Hendrick. “FDA OKs Generic Zyprexa for Schizophrenia, Bipolar Disorder”, WebMD, https://www.webmd.com/bipolar-disorder/news/20111025/fda-oks-generic-zyprexa-for-schizophrenia-bipolar-disorder. Accessed April 12, 2018.
  4. Eli Lilly Pharmaceuticals. “Highlights of Prescribing Information”, Lilly.com, http://pi.lilly.com/us/zyprexa_relprevv.pdf. Accessed April 12, 2018.
  5. User sourced. “User Reviews for Zyprexa”, Drugs.com, https://www.drugs.com/comments/olanzapine/zyprexa.html?sort_reviews=most_helpful. Accessed April 12, 2018.
  6. Alex Berenson. “Lilly Adds Strong Warning Label to Zyprexa, a Schizophrenia Drug”, NYTimes.com, https://www.nytimes.com/2007/10/06/business/06zyprexa.html. Accessed April 12, 2018.
  7. Alex Berenson. “Eli Lilly Said to Play Down Risk of Top Pill”, NYTimes.com, https://www.nytimes.com/2006/12/17/business/17drug.html. Accessed April 12, 2018.
  8. Safety announcement “FDA Drug Safety Communication: FDA warns about rare but serious skin reactions with mental health drug olanzapine (Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and Symbyax)”, U.S. Food and Drug Administration, https://www.fda.gov/Drugs/DrugSafety/ucm499441.htm. Accessed April 12, 2018.
  9. Alex Berenson. “Lilly Settles With 18,000 Over Zyprexa”, NYTimes.com, https://www.nytimes.com/2007/01/05/business/05drug.html. Accessed April 12, 2018.
  10. Press release. “Eli Lilly and Company Agrees to Pay $1.415 Billion to Resolve Allegations of Off-label Promotion of Zyprexa”, U.S. Department of Justice, https://www.justice.gov/archive/opa/pr/2009/January/09-civ-038.html. Accessed April 12, 2018.
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