The Weekly Mortar & Pestle

Transcription

1 The Weekly Mortar & Pestle A Publication of Walgreens Health Initiatives The accuracy and completeness of the content herein are not guaranteed by Walgreen Co. or its affiliates and subsidiaries. Content not to be construed as a solicitation or recommendation. Brand names are the property of their respective owners Walgreens Health Initiatives. All rights reserved. 1 April 10, 2008 A publication created especially for our clients and associates, delivering up-to-date information about brand-name and generic medication, medical products, and other pharmaceutical-related information collected from key government and industry sources. Recent Food and Drug Administration (FDA) warnings and health news for patients and healthcare professionals (Updates to previously printed news are noted in blue.) Relenza (zanamivir) inhalation/glaxo SmithKline Issue: Label changes 04/02/08 GlaxoSmithKline informed healthcare professionals of changes to the Warnings and Precautions sections of Relenza prescribing information, including postmarketing reports of delirium and abnormal behavior leading to injury among influenza patients receiving neuraminidase inhibitors, including Relenza. Most of these reports were from Japan, and these events were reported primarily among pediatric patients who exhibited abrupt onset and rapid resolution. Low Low utilization. Association between Relenza and these effects is not clear. Communication to clients via Weekly M&P newsletter. Influenza Medication Quantity Limit is in place.

2 Relenza s role in these events has not been established. Influenza can be associated with many neurologic and behavioral symptoms including seizures, hallucinations, delirium, and abnormal behavior, sometimes resulting in fatal outcomes. Patients with influenza should be monitored Singulair (montelukast) tablets/merck Issue: FDA alert for abnormal behavior. 03/27/08 The FDA is informing healthcare professionals and patients of its investigation of a possible association between Singulair and behavior and mood changes, suicidality (suicidal thinking and behavior), and suicide. Singulair is indicated for the treatment of asthma and symptoms of allergic rhinitis and the prevention of exercise-induced asthma. Healthcare professionals should monitor patients taking Singulair for these types of changes. Patients should talk to their healthcare providers if they have questions about the new information. Patients should not stop taking Singulair before talking to their healthcare providers. The FDA may take up to nine months to complete its investigations before sharing its conclusions and recommendations with the public. Low High utilization. Association between Singulair and these effects is not clear. Communication to clients via Weekly M&P newsletter. Leukotriene Antagonists Step Care is in place. 2

3 Videx (didanosine) tablets and Videx EC capsules/bristol Myers-Squibb and Ziagen (abacavir) tablets/ GlaxoSmithKline Issue: Preliminary study findings Vytorin (ezetimibe/ simvastatin) tablets and Zetia (ezetimibe) tablets/merck and Schering-Plough Issue: Study findings 03/27/08 Recent results from the Data Collection on Adverse Events of Anti-HIV Drugs Study found a higher risk of heart attack in HIV-1 patients taking Videx or Ziagen as part of their drug therapy. Patients in this study are being followed to evaluate the short- and long-term adverse effects of treatment with anti-hiv drugs. The FDA will continue to evaluate the overall risks and Videx and Ziagen, which may result in the need for revised product labeling. Healthcare professionals are advised to evaluate the potential risks and each HIV antiretroviral drug. 04/03/08 The ENHANCE trial was published in the April 3, 2008 issue of the New England Journal of Medicine. The ENHANCE study enrolled 720 patients who received either Vytorin or simvastatin alone. As an endpoint, investigators looked at the growth of plaques on arterial walls using ultrasound imaging. The findings indicated no additional benefit on plaque growth with Vytorin versus simvastatin alone. There was no difference in side effects, and the overall incidence rates of cardiac events were nearly identical between the treatment groups. Low Low utilization. Potential risks have been communicated to healthcare professionals. Medium High utilization. Study does not provide adequate evidence of effectiveness in reducing cardiovascular events. Communication to clients via Weekly M&P newsletter. Vytorin and Zetia are preferred agents on the WHI formulary. No changes are planned. 3

4 Moreover, the low-density lipoprotein (LDL) cholesterol was significantly lowered in the Vytorin group compared to those who received simvastatin alone. This study does not provide adequate evidence of negative or positive clinical outcomes for patients taking Vytorin or Zetia. New Products* Drug/ Manufacturer Reyataz (atazanavir) capsules/bristol Myers-Squibb Therapeutic Class Anti-HIV agent Indication(s) Date Projected Comments Launch New FDA-Approved Agents New Dosage Forms & Combinations New FDA-Approved Indications Treatment of HIV infection in pediatric patients age 6 to 18 03/25/08 Available Reyataz is used in combination with other anti- HIV medications for the treatment of HIV infection. New First-Time Generic Drug Approvals * Note: If FDA-approved, agents are under P&T review and reside on the 3 rd tier. Programs Planned Preferred class. MedMonitor will review for conflict edit updates. Pipeline Analysis Drug/Manufacturer Therapeutic Class Indication(s) Status Comments First-Time Generic Drugs in the Pipeline 4

5 Information for Mortar & Pestle is obtained from the following sources (with secondary-source links provided): Food and Drug Administration ( American Society of Health-Systems Pharmacists ( P&T Community ( Pharmaceutical News Harvest ( Drugs.com ( Pharmacy OneSource ( 5