CLINICAL CORNER

Quarterly Drug Information Corner

Vaccine Update

Intra Nasal Influenza Vaccine – The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) voted to recommend that the live attenuated influenza vaccine (LAIV; FluMist quadrivalent) should not be used in the United States for the 2016 to 2017 influenza season.   This is an interim recommendation, as there may be additional data obtained prior to the start of this year’s flu season.

Data has shown during the last three flu seasons (2013-2014 through 2015-2016) that FluMist has not been effective in those aged 2 to 17 years.  Tests of active military personnel showed poor vaccine effectiveness for the 2013-2014 flu season.

FluBlok Shelf Life Extended – The FDA approved extending the shelf life from 6 months to 9 months.   FluBlok is the first recombinant protein-based vaccine that is made 100% egg free.  FluBlok contains no preservatives, gelatin or latex, and contains three times more antigen than traditional flu vaccines.

Safety Updates

Strengthened Warnings for diabetes medications – The FDA has strengthened the existing warning about the risk of acute renal injury for the type 2 diabetes medications canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR).   Health care professionals should consider factors that may predispose patients to kidney injury such as chronic kidney insufficiency; congestive heart failure; and taking other medications such as diuretics, ACE inhibitors, angiotensin receptor blockers (ARBs) and NSAIDs.

Substance Abuse

The abuse of Loperamide (Imodium) is increasing and is being linked to arrhythmias and death.  Loperamide used to be a Schedule V but when it was approved in the 1980s for over-the-counter use it was no longer a controlled substance.  Loperamide has earned the nickname “poor man’s methadone” because high doses can lead to an opioid-like effect.

New Drugs

Viberzi (eluxadoline) has been FDA approved for the treatment of irritable bowel syndrome with diarrhea (IBS-D).  Viberzi is an opioid agonist, similar to Loperamide and is a schedule IV controlled substance.  Viberzi is modestly effective, only about 1 patient in 11 has less diarrhea compared to placebo.

FDA approves Epclusa (sofosbuvir and velpatasvir) for adults with chronic hepatitis C virus and is the first medication to treat all six major genotypes of HCV.  With Epclusa’s broad coverage this could be the first one agent treats all.    In clinical trials, after 12 weeks of therapy, Epclusa showed no detectable serum virus in 95%-99% of patients.  Headache and fatigue are the most common side effects.  The drug label warns against administering Epclusa with amiodarone because of reports of symptomatic bradycardia.

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