Zyprexa: Recent News and Research

Zyprexa (olanzapine) is an atypical antipsychotic drug that treats schizophrenia. Eli Lilly and Company is the manufacturer of Zyprexa. The Food and Drug Administration (FDA) approved the drug in 1996. Healthcare providers have prescribed this drug to millions of patients over the years.

Clinicians also prescribe Zyprexa for the treatment of bipolar disorder in patients suffering from manic episodes. The FDA fact sheet indicates that adults and adolescents can take the drug. The FDA fact sheet also warns of Zyprexa's other side effects.

Adverse events of the antipsychotic drug Zyprexa include the following:

• Weight gain
• Increased risk of hyperglycemia
• Increased risk of suicide
• Higher incidence of death in elderly patients suffering from dementia
• Tardive dyskinesia

Zyprexa clinical trials have confirmed the above side effects. There have also been legal claims against the Indianapolis-based drugmaker Eli Lilly for promoting unapproved uses of the drug. Here, we'll discuss Zyprexa news and lawsuits.

Internal Eli Lilly Documents Posted Online

In February 2007, Eli Lilly filed for an injunction in New York federal court to prevent internal documents from being posted online. An injunction is a legal order prohibiting a person from engaging in a particular behavior.

A former employee allegedly wanted to post copies of internal documents regarding the drugmaker's marketing of Zyprexa for off-label uses.

These documents also showed that the drug manufacturer concealed evidence that Zyprexa caused:

• Weight gain
• Diabetes
• Hyperglycemia
• Cardiovascular disease

The Eastern District of New York rejected Eli Lily & Co.'s request for an injunction. The judge said trying to prevent someone from posting this information on the internet would be pointless. He also held that there was no First Amendment right to protect these documents.

Eli Lilly Settles Lawsuits for Off-Label Uses of Zyprexa

On January 15, 2009, the Justice Department announced that it had settled multiple claims against the manufacturer of Zyprexa. The federal and state governments sued Eli Lilly for fraudulent marketing of its antipsychotic drug and for submitting fraudulent healthcare claims.

The drugmaker marketed the drug to long-term care facilities for off-label uses. Specifically, the company trained its sales staff to convince doctors to prescribe the drug for the following:

• Hostility and aggression
• Generalized sleep disorders
• Dementia
• Alzheimer's
• Depression
• Mood disorders

The company knew the FDA hadn't approved Zyprexa for these uses. The Food, Drug, and Cosmetic Act forbids drug manufacturers from marketing their products for off-label uses. Unless the FDA specifically approves a drug for off-label use, drugmakers must refrain from promoting off-label use of Zyprexa.

The federal government and state attorneys general sued Eli Lilly and Company in the U.S. District Court for the Eastern District of Pennsylvania. In January 2009, the parties settled the claims for more than $1.4 billion. The agreement was for Eli Lilly to pay more than $800 million in civil damages and another $515 million in criminal fines.

Class Action Lawsuit for Patient Deaths

In June 2013, the FDA reported that it was investigating the death of two Zyprexa patients who died within hours of taking the drug. Both patients suffered from post-injection delirium/sedation syndrome (PDSS). This is a condition where a drug sedates a patient to the point where they lapse into a coma.

A small number of people who experience PDSS never regain consciousness. This was the case for two Zyprexa patients. In 2015, the New York Times reported that the FDA had closed its investigation into the deaths. This was good news for the drug manufacturer but bad news for the victims' family members. The Zyprexa products liability litigation also came to an end.

FDA Warns About Rare Skin Rash

In May 2016, the FDA ordered Eli Lilly & Co. to change the label to warn about a rare but serious skin condition called DRESS. According to the FDA, patients taking Zyprexa and other olanzapine-containing products were at an increased risk of developing this skin disease.

Drug reaction of eosinophilia and systemic symptoms (DRESS) is a dangerous skin rash that spreads throughout your body. Patients who notice a fever with a rash should seek immediate medication attention. Patients with DRESS may also notice swelling around the face and neck.

Prescribing physicians must warn patients of this risk. The drugmaker's package insert should include information about this side effect as well.

Study Shows Zyprexa More Effective in the Long-Term

In 2019, the journal Neuropsychiatry Disorder Treatment published a study on the effectiveness of Zyprexa. According to this study, many clinicians prescribe olanzapine to patients with schizophrenia. It doesn't require constant blood monitoring. But one of the major side effects of Zyprexa is weight gain.

Clinicians often have trouble convincing patients to continue taking antipsychotics that make them gain weight. Researchers investigated whether this side effect impacted the long-term use of olanzapine. Specifically, this study evaluated the "time to relapse" rate of Zyprexa compared to Haldol.

The study found that while Zyprexa is a second-choice antipsychotic medication, it has long-term effectiveness. The time-to-relapse rate for Zyprexa was only 20% compared to 28% for Haldol.

FDA Approves New Combination Atypical Antipsychotic Drug

In June 2021, the FDA approved a new atypical antipsychotic drug. Alkermes plc's prescription medication, Lybalvi, combines olanzapine and samidorphan. The new medication had fewer side effects than most antipsychotics. Another benefit of Lybalvi is that it doesn't cause weight gain like Zyprexa.

According to the FDA, doctors often give Lybalvi to patients taking lithium or valproate. Doctors prescribe this new drug to treat schizophrenia or bipolar I disorder. Lybalvi helps treat acute manic and mixed episodes.

What To Do if You Become Sick After Taking Zyprexa

If you or your loved one get sick after taking Zyprexa or olanzapine, seek immediate medical attention. Depending on the facts of your case, you may be able to file a lawsuit against the drug manufacturer for product liability claims. Talk to an experienced product liability attorney to learn more about potential claims.