Zyprexa
Zyprexa FDA Information
ZYPREXA (Olanzapine) FDA INFORMATION
The FDA issued several warnings concerning Zyprexa related side effects. The links below will redirect you to these warnings on the FDA website.
Quick Facts
Zyprexa Side Effects Could Be Linked To Diabetes, Deadly Heart Risk, Torsades de Pointes
Zyprexa Side Effects Could Be Linked To Diabetes, Deadly Heart Risk, Torsades de Pointes
Recently, 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, this can lead to a ventricular fibrillation (where the heart essentially stops pumping blood) 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.
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%, 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.
The popular schizophrenia drug Zyprexa has been linked to serious side effects including diabetes, hyperglycemia and other blood sugar disorders. The FDA has asked Eli Lilly, the manufacturer or Zyprexa, to add a new warning to the drug, warning patients of these side effects.
In a recent study, Zyprexa and two other atypical antipsychotics that are used to treat schizophrenia were found to cause diabetes 50 percent more often than older drugs.
Last year, Britain's Medicines Control Agency warned that several patients taking Eli Lilly's top selling drug Zyprexa (used to treat schizophrenia) had developed diabetes-related complications. In the Medicine Control Agency's Current Problems newsletter, the regulatory body said 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 said seven other patients had lost consciousness or become comatose after taking the drugs in the last 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 reports the FDA has been alerted 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.
On April 11, 2005, the FDA announced that older patients with dementia who are given antipsychotic medicines are far more likely to die prematurely than those given dummy pills. The warning adds to growing worries about the safety of the widely prescribed drugs. The Food and Drug Administration said that it would now require manufacturers of the medicines to place black-box warnings the agency's most severe on the labels of all the drugs.
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 a loved one were affected by Zyprexa, please fill out the form at the right for a free case evaluation by a qualified attorney or call us anytime at 1-800-LAW-INFO (1-800-529-4636).










