Eli Lilly & Co. paid about $3 billion to settle thousands of lawsuits from people who were injured by Zyprexa. Now, a growing number of people are coming forward to report severe skin reactions, heart attacks, and other side effects.
What is Zyprexa?
Zyprexa (olanzapine) is an anti-psychotic medication made by Eli Lilly & Co. It was approved by the FDA in 1996 for the treatment of severe mental illnesses like schizophrenia and bipolar disorder. It works by balancing chemicals in the brain (serotonin and dopamine) to prevent hallucinations and delusions.
Eli Lilly Pays $500 Million Zyprexa Settlement
In January 2007, Eli Lilly agreed to pay $500 million to settle 18,000 Zyprexa lawsuits from people who claim they developed diabetes or other health problems. Including earlier settlements, the company paid about $1.2 billion to resolve lawsuits involving 28,500 people.
Eli Lilly Pays $1.42 Billion to Settle Investigation Over Zyprexa Marketing
In January 2009, the Justice Department accepted a $1.42 billion settlement after Eli Lilly agreed to plead guilty for promoting Zyprexa for “off-label” uses that were not approved by the FDA.
Investigators say Eli Lilly promoted Zyprexa for elderly adults with dementia — including patients with Alzheimer’s — which are unapproved uses. The label now has a “Black Box” warning that Zyprexa increases the risk of death for elderly patients with dementia-related psychosis.
FDA Warning: Rare but Serious Skin Reactions
In May 2016, the FDA issued a Safety Communication and updated the label on Zyprexa to warn about a rare but severe, life-threatening skin reaction known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
The condition causes inflammation and swelling due to abnormally increased levels of eosinophils, which are white blood cells that fight infections.
The FDA identified 23 reports of patients who developed DRESS since 1996. DRESS has a mortality-rate of about 10%, and one patient died of cardiac arrest. However, that patient was on other medications that may have contributed.
According to the FDA:
“DRESS may start as a rash that can spread to all parts of the body. It can include fever and swollen lymph nodes and a swollen face. … DRESS can result in injury to organs including the liver, kidneys, lungs, heart, or pancreas, and can lead to death.”
FDA Closes Investigation Into Zyprexa Deaths
The FDA has closed an investigation into two deaths linked to Zyprexa Relprevv. However, the agency could not determine whether the deaths were caused by rapid entry of Zyprexa into the bloodstream. The agency became concerned after doctors reported extremely high levels of the drug in the bloodstream of two schizophrenia patients who died after receiving injections of Zyprexa.