Zyprexa Side Effects Could Be Linked To Diabetes, Deadly Heart Risk, Torsades de Pointes, and the Sometimes Fatal Skin Disease, DRESS
The popular schizophrenia drug Zyprexa—known generically as olanzapine and sold under the brands Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and Symbyax—has been linked to serious side effects including diabetes, hyperglycemia, and other blood sugar disorders; heart risks and Torsades de Pointes, and Drug Reaction with Eosinophilia and Systemic Symtoms (DRESS).
In 2013, the U.S. Food and Drug Administration (FDA) asked Eli Lilly, the manufacturer or Zyprexa, to add a new warning to the drug, warning patients of diabetes, deadly heart risk, and Torsades de Pointes. In May 2016, the agency updated this to include DRESS.
Zyprexa Associated with Potentially Fatal DRESS Skin Reaction
On May 10, 2016, the FDA issued a warning that olanzapine/Zyprexa may lead to a potentially fatal skin reaction that can cause damage to other parts of the body, including organ damage. This is the most recent warning that the agency has issued on Zyprexa, its various brands and its generics and their ties to the severe condition known as DRESS.
Scott MacGregor, an Eli Lilly spokesman, told Law360 that, "Based on analysis of our safety database, and the knowledge that prompt recognition and early intervention is key to managing this life-threatening condition, Lilly revised the olanzapine core data sheet to include [the reaction]." He added that product labels in the United States and Europe are being updated.
Meanwhile, an FDA database (FAERS) search revealed 23 cases of Dress reported with Zyprexa/olanzapine used worldwide since 1996, which is when the first olanzapine-containing product was approved, according to the federal regulators. The FDA noted that its database only includes those reports submitted to the FDA; therefore, additional cases about which the agency is unaware, are likely.
According to Law360, the agency explained that the reaction may begin as a rash that may spread to all parts of the patient’s body and may also include fever, a swollen face, and swollen lymph nodes. Dress may also lead to a greater-than-normal amount of while blood cells, a condition known as eosinophils that may then lead to swelling and inflammation, the FDA noted. White blood cells are responsible for fighting infection in the body. DRESS organ injury may include the liver, kidneys, lungs, heart, and pancreas and may also cause death, according to the FDA, which noted that not only is DRESS potentially fatal, the death rate is as high as 10 percent.
This is not the first time the FDA has expressed concern about the schizophrenia and bipolar disorder. Following the death of two patients after being injected with Zyprexa Relprevv in 2013, the FDA opened an investigation. The agency indicated that the deaths were unexplained; however, both patients were discovered to have "very high" olanzapine blood levels. The findings were published in March 2015. In 2008, the agency issued a caution about excessive sedation associated with the long-form version of Zyprexa.
Also, Zyprexa’s alleged side effects have led to ongoing litigation against Eli Lilly. In fact, in 2012, Eli Lilly reached a $4.5 million settlement to resolve allegations brought by an insurer and five union health funds that they overpaid Zyprexa because Eli Lilly neglected to reveal its adverse side effects.
The FDA recommends that physicians to immediately cease treatment with Zyprexa/olanzapine if DRESS is suspected. There is no specific treatment for DRESS; however, management involves early recognition of the syndrome, discontinuation of the offending agent (drug) as soon as possible, and supportive care, wrote MedScape MultiSpecialty. For example, treatment with systemic corticosteroids is a consideration in those cases when extensive organ involvement occurs. When prescribing the medicine, physicians should also be sure to explain the signs and symptoms of severe skin reactions, such as DRESS to their patients and should tell them when to seek immediate medical care.
In 2013, the U.S. Food and Drug Administration (FDA) asked Eli Lilly, the manufacturer or Zyprexa, to add a new warning to the drug, warning patients of diabetes, deadly heart risk, and Torsades de Pointes.
Zyprexa Tied to Torsades de Pointes
Zyprexa has been linked to an increased risk of Torsades de Pointes, a potentially fatal abnormality in the heart rhythm. Torsades de Pointes occurs when the bottom chambers of the heart beat too quickly; this prevents blood from being pumped to the brain and the patient often loses consciousness. If not corrected right away, Torsades de Pointes may lead to a ventricular fibrillation, (in which the heart essentially stops pumping blood), which will likely lead to and death. In April 2013, Drug Safety published a study showing that Zyprexa and two other antipsychotic medications were associated with a higher risk for Torsades de Pointes. Using the FDA’s Adverse Events Reporting System (AERS), researchers identified 450 cases of QT interval abnormalities (meaning that heart cells take a long time to recharge), 41 cases of Torsades de Pointes, 2,971 cases of cardiac arrhythmia and 943 instances of cardiac death between November 1997 and August 2012 where Zyprexa was listed as a suspect drug.
Zyprexa Tied to Diabetes
Eli Lilly and Co. announced on June 9, 2005 that it has entered into an agreement in principle to settle about 8,000, or 75 percent, of the claims against the company related to its schizophrenia medication, Zyprexa. The agreement involves claimants who asserted they developed diabetes-related conditions from their use of Zyprexa.
In a recent study (2013), Zyprexa and two other atypical antipsychotics that are used to treat schizophrenia were found to cause diabetes 50 percent more often than older drugs.
Previously, Britain's Medicines Control Agency warned that several patients taking Eli Lilly's top selling drug Zyprexa had developed diabetes-related complications. In the Medicine Control Agency's Current Problems newsletter, the regulatory body said wrote that the antipsychotic drug "can adversely affect blood glucose."
Forty reports "of hyperglycemia (elevated blood sugar), diabetes mellitus, or exacerbation of diabetes have been received in the UK. Four were associated with ketoacidosis and/or coma including one with a fatal outcome," according to the newsletter. "The precise mechanism of this suspected adverse drug reaction has not yet been elucidated and is currently being investigated further.”
This follows an emergency report issued in April 2002 by the Japanese Health and Welfare Ministry to Eli Lilly Japan KK concerning side effects of Zyprexa after the deaths of two diabetic users of the drug. It reported that seven other patients had lost consciousness or had become comatose after taking Zyprexa in the prior 10 months.
The Japanese Ministry said no new diabetes patients should be treated with the drug and ordered Eli Lilly to warn doctors to closely monitor diabetics already on the medication.
A paper written in late 2001 in the Journal of Clinical Psychiatry reporteds that the FDA had been alerted to 19 case reports of diabetes associated with the use of Zyprexa. Of the 19 patients seven had newly diagnosed hyperglycemia. The sugar disorder developed within a week of taking Zyprexa in two patients and within six months for eight others. One patient ultimately died of necrotizing pancreatitis, a condition in which cells in the pancreas die.
Zyprexa and Patients Diagnosed with Dementia
On April 11, 2005, the FDA announced that older patients diagnosed with dementia who are given antipsychotic medicines are far more likely to die prematurely than those given dummy (placebo) pills. The warning adds to growing worries about the safety of the widely prescribed drugs. The FDA indicated that it would now require manufacturers of the medicines to place black-box warnings, the agency's most severe warning.
Zyprexa and Symbyax from Eli Lilly, Risperdal from Johnson & Johnson, Seroquel from AstraZeneca, Abilify from Bristol-Myers Squibb, Clozaril from Novartis and Geodon from Pfizer are all affected by the warning.
Legal Help For Victims Affected By Zyprexa
If you or someone you know were/was affected by Zyprexa and suffered from DRESS, diabetes, heart conditions, or death, please fill out the form at the right for a free case evaluation by a qualified attorney or call us anytime at 1-800-YOURLAWYER (1-800-968-7529).