Pharmaceutical Injuries - Zyprexa
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Eli Lilly and Co. said late Thursday, 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, federal drug regulators said Monday. 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.
Zyprexa Safety Information
FDA Information on Zyprexa
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