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Lilly Changes Zyprexa Prescribing Information for Indication for Use in Adolescents (Ages 13 to 17)
Lilly and the FDA notified healthcare professionals of changes to the Prescribing Information for Zyprexa related to its indication for use in adolescents (ages 13-17) for treatment of schizophrenia and bipolar I disorder (manic or mixed episodes). The revised labeling warns about the increased risk of weight gain and elevated cholesterol in adolescents and states that this safety issue should be considered by healthcare professionals when deciding among the treatments available for adolescents with schizophrenia and bipolar I disorder. Because of the the increased safety risks, especially with long-term use, healthcare professionals may consider prescribing other medicine first in adolescents. The updated prescribing information also stresses that Zyprexa should be prescribed for adolescents with schizophrenia and bipolar disorder as part of a total treatment program that includes psychological, educational, and social supportive measures for patients with the disorder. Zyprexa contains the active ingredient olanzapine. Zyprexa is also found in the combination product Symbyax. Zyprexa is indicated for use in adults and adolescents ages 13 to 17 for the treatment of schizophrenia and bipolar I disorder (manic or mixed episodes). However antipsychotics like Zyprexa are becoming more commonly used for many different mood and behavior conditions such as attention deficit hyperactivity disorder (ADHD) - they are often prescribed "off-label" to treat these conditions. For more information, please visit: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm198402.htm
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Eli Lilly and Company Publishes Notification of Stolen Products
Eli Lilly and Company is working with the U.S. Food and Drug Administration's Office of Criminal Investigations and other law enforcement officials to recover cases of select lots of pharmaceutical products that were stolen from one of Eli Lilly's warehouses located in Enfield, Connecticut, on Sunday, March 14, 2010. The company says the thieves stole select lots of the following: Medicines taken by mouth and available by prescription from a pharmacy: Cymbalta (duloxetine) Effient (prasugel) Prozac (fluoxetine) Strattera (atomoxetine) Symbyax (fluoxetine and olanzapine) Zyprexa (olanzapine) Medicines given as an infusion in a clinic or hospital: Alimta (pemetrexed Injection) Gemzar (gemcitabine) For more information and a detailed list of products stolen from the facility, please visit: http://lilly.com/pdf/Offiicial_Enfield_Communication_March18.pdf
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Date Published Title Drug Source
2010-02-02 Lilly Changes Zyprexa Prescribing Information for Indication for Use in Adolescents (Ages 13 to 17) Fluoxetine with Olanzapine Manufacturer
2010-03-23 Eli Lilly and Company Publishes Notification of Stolen Products Fluoxetine with Olanzapine Manufacturer
2008-06-17 New Boxed Warning on Older Class of Antipsychotic Drugs Fluphenazine FDA
2009-06-08 Antipsychotics Linked With Sudden Cardiac Death Fluphenazine MediGuard CRT
2012-03-19 Teva Pharmaceuticals Recalls Single Lot of Flutamide Capsules 125 mg Flutamide FDA
2011-03-01 Nycomed Recalls Single Lot of Fluticasone Propionate Ointment, 0.005% Fluticasone FDA
2010-04-20 Apotex Recalls One Lot of Fluticasone Nasal Spray Fluticasone Nasal FDA
2009-08-25 Two Lots of Advair Diskus Reported Stolen Fluticasone Propionate with Salmeterol FDA
2009-10-18 Recall of Single Lot of Advair Diskus 100/50mcg Fluticasone Propionate with Salmeterol FDA
2010-07-16 Stolen Advair Inhalers Appear in Pharmacies Fluticasone Propionate with Salmeterol FDA
2012-12-11 GlaxoSmithKline Recalls Several Lots of Advair HFA 45/21 Inhalers Fluticasone Propionate with Salmeterol FDA
2011-03-01 Nycomed Recalls Single Lot of Fluticasone Propionate Ointment, 0.005% Fluticasone Topical FDA
2008-11-10 Cholesterol-lowering Medications May Increase Risk of Confusion After Surgery Fluvastatin MediGuard CRT
2009-08-28 Study Supports Link Between Statins and Muscle Pain and Weakness Fluvastatin MediGuard CRT
2011-01-31 GSK Informs Customers of Important Information About Alcohol Prep Pads in Arixtra Starter Kits Fondaparinux FDA
2011-05-02 Novartis Pharmaceuticals Recalls Single Lot of Foradil Aerolizer (formoterol fumerate inhalation powder), 12 mcg Formoterol FDA
2010-02-18 New Safety Requirements for Long-acting Inhaled Asthma Medications Called Long-Acting Beta-Agonists (LABAs) Formoterol with Budesonide FDA
2009-12-03 Safety Update to Prescribing Information for Lexiva (Fosamprenavir) Fosamprenavir FDA
2014-01-08 FDA Warns of Possible Harm From Exceeding Dose of Over-the-Counter Enemas and Oral Solutions Used to Treat Constipation FDA
2008-08-12 Angioedema and ACE inhibitors Fosinopril MediGuard CRT
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