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 January 17, 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 Drug/Issue Date News Event(s) Member/ Bisphosphonates (marketed as Actonel, Actonel with Calcium, Aredia, Boniva, Didronel, Fosamax, Fosamax Plus D, Reclast, Skelid, and Zometa )/multiple manufacturers Issue: FDA alert 01/07/08 The FDA informed healthcare professionals and patients of the possibility of severe and sometimes incapacitating bone, joint, and musculoskeletal pain in patients taking bisphosphonates. Although severe musculoskeletal pain is included in the prescribing information for all bisphosphonates, the association between bisphosphonates and severe musculoskeletal pain may be overlooked by healthcare professionals. This may delay a diagnosis, prolong pain or impairment, and necessitate the use of analgesics. High utilization. These side effects have been known. The FDA warning will increase overall awareness of these effects and prompt evaluation of continuing therapy on a caseby-case basis. MedMonitor will review for criteria addition.

2 Drug/Issue Date News Event(s) Member/ The severe musculoskeletal pain may occur within days, months, or years after starting a bisphosphonate. Some patients have reported complete relief of symptoms after discontinuing the bisphosphonate, whereas others have reported slow or incomplete resolution. The risk factors for and incidence of severe musculoskeletal pain associated with bisphosphonates are unknown. Healthcare professionals should consider whether bisphosphonate use might be responsible for severe musculoskeletal pain in patients who present with these symptoms and consider temporary or permanent discontinuation of the Edecrin (ethacrynic acid) tablets/aton Pharma Issue: Drug shortage drug. 01/07/08 Edecrin tablets from Aton Pharma are out of stock. Action has not provided a reason for the shortage and has not announced an estimated release date. Sodium Edecrin (ethacrynate sodium) injection is not affected by this shortage. Very low utilization. Supply is expected to meet demand. Affected members should contact their physician for alternatives. Member communication will not be sent as this event does not meet Industry Events Quick Response team criteria. 2

3 Drug/Issue Date News Event(s) Member/ Vytorin (ezetimibe/ simvastatin) tablets and Zetia (ezetimibe) tablets/ Merck and Schering- Plough Issue: Study findings 01/14/08 Merck and Schering-Plough released the primary endpoint results and other data from the ENHANCE trial in a news release due to the scientific community s significant interest. MSP has submitted an abstract for presentation at the American College of Cardiology in March, but the study has not been published. The ENHANCE study enrolled 720 patients who received either Vytorin or simvastatin alone. Investigators studied the growth of plaques on arterial walls using ultrasound imaging. The findings indicated no additional benefit on plaque growth with Vytorin vs simvastatin alone. There was no difference in side effects, and the overall incidence rates of cardiac events were nearly identical between the treatment groups. Moreover, the low-density lipoprotein cholesterol was significantly lowered in the Vytorin group compared to those receiving simvastatin alone. This study does not provide adequate evidence of negative or positive clinical outcomes for patients taking Vytorin or Zetia. Until more evidence is clearly established, clinical benefits of these s should be evaluated on a case-by-case basis. High utilization of these s, but the study data is inconclusive. Patients should continue Vytorin or Zetia as prescribed and discuss any questions they have with their doctors. New Products* Drug/ Manufacturer Indication(s) Date Projected Launch Comments New FDA-Approved Agents None to report Programs Planned 3

4 Drug/ Manufacturer Sular (nisoldipine) extended-release (ER) tablets/ Sciele Pharma Vyvanse (lisdexamfetamine) 20 mg, 40 mg, and 60 mg capsules/shire Cialis (tadalafil) 2.5 mg and 5 mg tablets/eli Lilly Ipratropium 0.5 mg/albuterol 3 mg solution for inhalation/ Watson Blood pressure Attention deficit hyperactivity disorder (ADHD) Genitourinary Antiasthmatic Indication(s) Date Projected Launch Comments New Dosage Forms and Combinations 01/02/08 First quarter All current tablets in 10 hypertension of 2008 mg, 20 mg, 30 mg, and 40 mg strengths will be replaced with lower, bioequivalent strengths of 8.5 mg, 17 mg, 25.5 mg, ADHD erectile dysfunction (ED) bronchospasm associated with chronic obstructive pulmonary disease 01/07/08 Second quarter of 2008 and 34 mg ER tablets. Vyvanse is currently available as 30 mg, 50 mg, and 70 mg capsules. New FDA-Approved Indications 01/07/08 The 5 mg Cialis was approved for tablets are daily use in the available. It treatment of ED. is unknown With the new dosing when 2.5 regimen, men can mg tablets attempt sexual activity will be at any time between available. doses. New First-Time Generic Drug Approvals 12/31/07 Immediately The medication is the generic equivalent of DuoNeb. Programs Planned P&T review planned. MedMonitor will update criteria as needed. Vyvanse is currently nonpreferred. No changes planned. Medication Management will update existing ADHD CPA. MedMonitor will update criteria as needed. Cialis is currently nonpreferred. No changes planned. MM will update existing Impotency CPA. MedMonitor will review for criteria updates. Will be added to lowest copay tier when available. 4

5 * Note: If FDA-approved, s are under P&T review and reside on the 3 rd tier. Pipeline Analysis Drug/Manufacturer Alogliptin (SYR- 322), oral/takeda Effient (prasugrel), oral/daiichi Sankyo TAK-390MR/TAP Pharmaceuticals Antidiabetic Platelet inhibitor Gastrointestinal Indication(s) Status Comments type 2 diabetes acute coronary syndrome (ACS) erosive esophagitis and gastroesophageal reflux disease New drug application (NDA) submitted. NDA submitted. NDA submitted. First-Time Generic Drugs in the Pipeline None to report Alogliptin is a highly selective dipeptidyl peptidase-4 inhibitor. Prasugrel is in development for the treatment of ACS managed with percutaneous coronary intervention, including coronary stenting. TAK-390MR is a proton pump inhibitor with a novel delivery system used to treat acid-related diseases and treatment and maintenance of erosive esophagitis and nonerosive reflux disease. 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