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Formulary, A peer-reviewed drug management journal for managed care and hospital decision-makers
Part of the Modern Medicine Network

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FormularyJournal.com

July 15, 2011

Formulary
Home Medication Safety FDA Actions Latest News Policy Watch Drug Watch
In This Issue
Alternative to NSAIDs should be considered for patients with CAD, hypertension
SSRIs during first trimester increase risk of congenital anomalies
Qualitest recalls pain-relief tablets due to label mix-up
DMARDs may reduce diabetes risk for patients with RA, psoriasis
FDA approves Boostrix to help prevent whooping cough in older adults
FDA wants input on proposed policy for diagnostic tests used with targeted drug therapies
Multaq phase 3 study halts; increased cardiovascular events cited

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This month we would like to know...

With the recent introduction of 2 new protease inhibitors as adjunctive therapies for the management of hepatitis C, what do you envision your organization's approach will be to managing the use of these products?

a) Selection of 1 preferred product only

b) Maintain both agents on formulary and allow providers to choose

c) Employ prior authorization to validate clinical appropriateness before coverage

d) a & c

e) b & c

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Digital Edition

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Alternative to NSAIDs should be considered for patients with CAD, hypertension

Chronic self-reported use of nonsteroidal anti-inflammatory drugs (NSAIDs) in patients with coronary artery disease (CAD) and hypertension is associated with harmful outcomes and alternative methods of pain relief should be considered, according to a study in the July issue of The American Journal of Medicine. Read full article.

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SSRIs during first trimester increase risk of congenital anomalies

Exposure to fluoxetine and paroxetine in early pregnancy is associated with a small but established risk of specific cardiac anomalies, according to a study published in the July issue of Obstetrics and Gynecology. Read full article.

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Qualitest recalls pain-relief tablets due to label mix-up

A voluntary nationwide retail level recall of generic pain-relief tablets combining butalbital, acetaminophen, and caffeine, as well as one combining hydrocodone bitartrate and acetaminophen is currently under way, according to a press release from FDA's website on June 24. Read full article.

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DMARDs may reduce diabetes risk for patients with RA, psoriasis

Disease-modifying antirheumatic drugs (DMARDs) may lower diabetes (DM) risk in patients with rheumatoid arthritis (RA) or psoriasis, according to a study published in the June 22 issue of the Journal of the American Medical Association. Read full article.

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FDA approves Boostrix to help prevent whooping cough in older adults

FDA has approved Boostrix [Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine, Adsorbed (Tdap); GlaxoSmithKline Biologicals] for use in adults 65 years of age and older for active booster immunization against tetanus, diphtheria, and pertussis (whooping cough). This approval makes Boostrix the first Tdap vaccine approved for use by this age group. Read full article.

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FDA wants input on proposed policy for diagnostic tests used with targeted drug therapies

FDA issued a new draft guidance to facilitate the development and review of companion diagnostics—tests used to help healthcare professionals determine whether a patient with a particular disease or condition should receive a particular drug therapy or how much of the drug to give. The draft document is intended to provide companies with guidance on the agency's policy for reviewing a companion diagnostic and the corresponding therapy. Read full article.

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Multaq phase 3 study halts; increased cardiovascular events cited

Dronedarone (Multaq, Sanofi), which is approved for nonpermanent atrial fibrillation (AF), was being tested on patients with permanent AF. However, that trial, PALLAS (Permanent Atrial fibrillation outcome Study using Dronedarone on top of standard therapy) phase 3b, has been terminated because it was causing increased cardiovascular events. Read full article.

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