January 2016 Issue of FYDI - For Your Drug Information
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Co-edited by:
Linda Nguyen, Pharm.D. Candidate
Gregory W. Smith, Pharm.D., Director, Drug Information Services
Greetings from the Drug Information Center at the University of Louisiana at Monroe School of Pharmacy

We hope you find this newsletter service helpful in staying well-informed. We continue to provide drug information services to healthcare professionals as a courtesy, so take a few moments to 
learn more about our Drug Information Services. 

Please contact us for assistance with your drug information needs by any of the following: 
          Phone 318.342.5501
          Online Drug Information Requests

In this issue, read about current...
          FDA MedWatch and Other Safety Alerts
          News Items
          Drug Approvals
          New Guidelines

Learn more about our Drug Information Services

FDA MedWatch and Other Safety Alerts...

CDER Alert:  Ma Ying Long’s OTC Licorice Coughing Liquid Contains Morphine
The FDA is warning consumers not to use Licorice Coughing Liquid, a cough syrup product manufactured by Ma Ying Long Pharmaceutical Group, because it contains unidentified morphine.
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Recall:  Unexpired Sterile Products by Abbott’s Compounding Pharmacy
Due to concerns of lack of sterility assurance, Abbott’s Compounding Pharmacy is voluntarily recalling all unexpired lots of sterile compounded products that were distributed within California.
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Recall:  Perrigo Children’s Guaifenesin and Guaifenesin DM Liquid
Due to the potential defect with the dosage cup, Perrigo announced a voluntary product recall to the retail level of its children’s guaifenesin grape liquid and its children’s guaifenesin DM cherry liquid.
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Recall: Shakti Group’s L.G Compounded Asafoetida Powder Contamination
Due to the potential contamination with Salmonella, Shakti Group is recalling 50 gram and 100 gram sizes of L.G Compounded Asafoetida Powder.
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Recall:  Hospira Magnesium Sulfate in Water for Injection Incorrect Labeling
Due to the potential for the primary container barcode to be mislabeled, Hospira announced a voluntary recall of one lot of Magnesium Sulfate in Water for Injection.
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Recall:  Baxter IV Solutions Potential Presence of Particulate Matter
Due to the potential presence of particulate matter, Baxter announced a voluntarily recall of two lots of intravenous solutions, 0.9% Sodium Chloride Injection and 70% Dextrose Injection, that were distributed between June 6 and December 16, 2015.
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Drug Safety Communication:  Noxafil Dosing Errors and Label Changes
The FDA is cautioning about dosing errors and drug label changes indicating that the two oral formulations of the antifungal Noxafil (posaconazole) cannot be directly substituted for each other and require a change in dose.
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Recall:  PharMEDium Norepinephrine Bitartrate Admixture Discoloration
Due to a slight discoloration indicative of degradation in the admixture, PharMEDium is voluntarily recalling lots of Norepinephrine Bitartrate added to 0.9% Sodium Chloride.
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Drug Safety Communication:  Rosiglitazone–containing Diabetes Medicines
The FDA eliminates the Risk Evaluation and Mitigation Strategy for rosiglitazone-containing type 2 diabetes medicines which are approved as Avandia, Avandamet, Avandaryl, and generics after determining that data did not demonstrate an increased risk of heart attack.
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Potential Contamination:  Baclofen Active Pharmaceutical Ingredient
The FDA is alerting drug compounders that certain lots of baclofen manufactured by Taizhou Xinyou may be at risk for contamination with particulates and should not be used to compound sterile injectable drugs.
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Drug Safety Communication:  SGLT2 Inhibitors Include Warnings on Labels
The FDA has added warnings to the labels of sodium-glucose cotransporter-2 inhibitors, a specific class of type 2 diabetes medicines, about the risks of too much acid in the blood and of serious urinary tract infections resulting in hospitalization.
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Recall:  Glades Drugs’ Compounded Multivitamins Due to Vitamin D3 Content
Due to several adverse events potentially associated with the high amounts of Vitamin D3 (Cholecalciferol), Glades Drugs is voluntarily recalling compounded multivitamin capsules distributed nationwide.
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Drug Safety Communication:  Clozapine Monitoring for Neutropenia and REMS
The FDA is making changes to the requirements for monitoring, prescribing, dispensing, and receiving clozapine in the treatment of schizophrenia and the safety concerns about a life-threatening blood condition called severe neutropenia.
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Drug Safety Communication:  Iodine-containing Contrast Agents for Imaging
The FDA is advising that rare cases of underactive thyroid have been reported in infants following the use of contrast media containing iodine for X-rays and other medical imaging procedures.
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Drug Safety Communication:  Plavix  Long-term Treatment Risk of Death
The FDA has determined that long-term use of the blood-thinning drug Plavix (clopidogrel) does not increase or decrease the overall risk of death in patients with or at risk for heart disease.
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News Items...

Medicaid Drug Reimbursement and Medicaid Drug Rebate Program
The Centers for Medicare and Medicaid Services issues the Covered Outpatient Drugs final rule that assists states and the federal government in managing drug costs and creates a more fair reimbursement system.
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Exposure to Workplace Dust Triples Risk of Rheumatoid Arthritis
A case-control study found exposure to textile dust among women was associated with tripled risk of developing rheumatoid arthritis.
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Invasive Treatment for NSTEMI or Unstable Angina May Benefit Elderly
Patients aged 80 and older with NSTEMI or unstable angina benefitted from the invasive strategy, having a significantly lower rate of heart-related complications.
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Triamterene Enhances Hydrochlorothiazide’s Hypotensive Effect
An observational study indicates mean blood pressure was significantly lower with combination therapy of hydrochlorothiazide/triamterene than with hydrochlorothiazide alone.
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Small Reductions in Kidney Function May Damage Heart and Blood Vessels
Researchers found that kidney donors compared with controls, had an expected decline in kidney function, an increase in the mass of the left ventricle, and no difference in blood pressure.
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Heart Valves Made From Tissue May Be Better for Middle-aged Patients
Patients between the ages of 40 and 70 years who undergo aortic valve replacement should be strongly considered for bioprosthetic valves rather than metal-based valves, though the choice should be individualized for each patient.
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Concurrent Use of Antidepressants Linked to Better Control of Diabetes
A U.S. study suggests that diabetics who are depressed and currently taking antidepressants are linked to 95 percent higher odds that their blood sugar will be well controlled.
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Rainforest Plant May Play Role in Reversing Diabetes
The alkaloid harmine found in a rainforest vine called ayahuasca causes the production of new pancreatic beta cells, which work to keep blood sugar levels stable.
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Taking Statins Before and After Heart Surgery Help Reduce Complications
According to a review article in The Annals of Thoracic Surgery, using statins before and after coronary artery bypass grafting surgery can help reduce atrial fibrillation following surgery as well as reduce the risk of death.
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Long-Term Opioid Use Associated with New-onset Depression
A Saint Louis University study states that long-term opioid analgesic use of more than 30 days may impose a risk of new-onset depression.
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Zika Virus Case in Texas Confirmed
The CDC has confirmed a case of Zika virus, an untreatable mosquito-borne illness, in a Texas woman who traveled to Latin America and returned exhibiting common symptoms of Zika.
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Proton Pump Inhibitor Use Associated With Risk of Chronic Kidney Disease
According to an article by JAMA Internal Medicine, proton pump inhibitors appear to be associated with an increased risk of chronic kidney disease.
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Researchers Finding Better Treatment for Hospital-Acquired Diarrhea
Researchers have attained the crystal structure of a toxin from the bacterium Clostridium difficile, which will aid efforts to develop therapies to prevent the infection.
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Higher Fat DASH Diet Lowers Blood Pressure and Triglycerides
Researchers found that a higher fat DASH diet lowered blood pressure to the same extent as the DASH diet, but also reduced triglycerides and did not significantly raise low-density lipoprotein cholesterol.
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Antiviral Prescriptions Predicts Influenza Activity in the United States
According to the Walgreens Flu Index, compiled weekly retail prescription data for antiviral medications used to treat influenza suggest slight increases in flu activity in several populations in the south.
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Americans Consume More Sodium Than Recommended
More than 90 percent of children and 89 percent of adults aged 19 and older consume more sodium than the recommended limits in the 2015-2020 Dietary Guidelines for Americans.
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FDA Proposes Tanning Bed Age Restrictions
The FDA issued two proposed rules that would restrict use of sunlamp products to individuals 18 and older and would require sunlamp manufacturers and tanning facilities to take additional measures to improve the overall safety of these devices.
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FDA Approves Device to Monitor Life-Threatening Heart Rhythms
LifeVest wearable cardioverter defibrillator is FDA approved for certain children who are at risk for sudden cardiac arrest, but are not candidates for an implantable defibrillator.
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Drug Approvals...

FDA Approves Anthelmintic to Treat the Most Common Worm Infections
Emverm (mebendazole) is FDA approved to treat for pinworm, whipworm, common roundworm, common hookworm and American hookworm.
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FDA Approves Omnigraft to Treat Diabetic Foot Ulcers
Integra Omnigraft Dermal Regeneration Matrix (Omnigraft) is FDA approved to treat certain diabetic foot ulcers by providing an environment for new skin and tissue to regenerate and heal the wound.
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FDA Approves Zurampic to Treat Hyperuricemia Associated With Gout
Zurampic (lesinurad) is FDA approved to treat high levels of uric acid in the blood associated with gout when used in combination with a xanthine oxidase inhibitor, a drug approved to reduce the production of uric acid in the body.
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FDA Approves Uptravi to Treat Pulmonary Arterial Hypertension
Uptravi (selexipag) tablets are FDA approved to treat adults with pulmonary arterial hypertension, a debilitating rare lung disease that can lead to death.
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FDA Approves Basaglar an Insulin Glargine Injection to Treat Diabetes
Basaglar (insulin glargine) injection is a long-acting human insulin analog FDA approved to improve glycemic control in type 1 diabetes mellitus in adult and pediatric patients and type 2 diabetes mellitus in adults.
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FDA Approves New Treatment to Increase Recovery Time Post Surgery
Bridion (sugammadex) injection is FDA approved to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide for intubation or ventilation during surgery.
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FDA Approves Alecensa to Treat Lung Cancer Resistant to Xalkori
Alecensa (alectinib) is FDA approved to treat metastatic ALK-positive non-small cell lung cancer in patients who can no longer tolerate or whose disease no longer responds to treatment with Xalkori (crizotinib).
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FDA Approves First Emergency Treatment for Overdose of Chemotherapy
Vistogard (uridine triacetate) is FDA approved for the emergency treatment of adults and children who receive an overdose of fluorouracil or capecitabine, or who develop severe toxicities within four days of these cancer treatments.
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FDA Approves Vonvendi to Control Bleeding Episodes
Vonvendi is the first FDA approved recombinant von Willebrand factor for as needed treatment and control of bleeding episodes in adults 18 years of age and older who have von Willebrand disease.
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FDA Approves Kanuma to Treat Lysosomal Acid Lipase Deficiency
Kanuma (sebelipase alfa) is the first FDA approved treatment for pediatric and adult patients with a rare disease known as lysosomal acid lipase deficiency, which can lead to serious and life-threatening organ damage.
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FDA Approves Trivalent Influenza Vaccine with an Adjuvant
Fluad, a trivalent vaccine produced from three influenza virus strains is formulated with the adjuvant MF59 is FDA approved for the prevention of seasonal influenza in people age 65 years and older.
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FDA Approves a New Indication for BioThrax Vaccine
BioThrax (Anthrax Vaccine Adsorbed) is FDA approved to prevent disease following suspected or confirmed exposure to Bacillus anthracis in people ages 18 through 65 years of age along with recommended antibiotic treatment.
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FDA Approves a Combination Tablet Containing the Complete HIV-1 Regiment
Genvoya is an FDA approved fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide as a complete regiment for the treatment of HIV-1 infection in adults and pediatric patients.
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FDA Approves Nucala for Maintenance of Severe Asthma Exacerbations
Nucala (mepolizumab) is FDA approved for patients ages 12 years and older who have a history of severe asthma exacerbations despite receiving their current asthma medicines.
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FDA Approves First Oncolytic Virus Therapy for Treatment of Melanoma
Imlygic (talimogene laherparepvec) is the first FDA approved oncolytic virus therapy for the treatment of melanoma lesions in the skin and lymph nodes.
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FDA Approves Orphan Drug as Breakthrough Therapy for Hypophosphatasia
Strensiq (asfotase alfa) is the first FDA approved treatment for perinatal, infantile and juvenile-onset of hypophosphatasia, a rare disease.
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FDA Approves Chemotherapy for Resistant Liposarcoma and Leiomyosarcoma
Yondelis (trabectedin) is a chemotherapy FDA approved for patients who previously received chemotherapy for the treatment of liposarcoma and leiomyosarcoma.
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New Guideline on Long-Term Bisphosphonate Use
The American Society for Bone and Mineral Research released guidelines on the optimal duration of long-term bisphosphonate therapy in patients with osteoporosis.
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Updated Guideline on Diagnosis and Treatment of Hyponatraemia
The European Renal Best Practice updated the clinical practice guideline on the diagnosis and treatment of adults with hypotonic hyponatraemia.
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Updated Type 2 Diabetes Management Algorithm
The American Association of Clinical Endocrinologists and the American College of Endocrinology updated their algorithm for managing patients with type 2 diabetes advocating for glycemic control and stringent blood pressure and lipid targets.
View Here | View Summary
Updated Guideline for Atherosclerotic Occlusive Disease of Lower Extremities
The Society for Vascular Surgery has provided recommendations for evaluation and management of asymptomatic peripheral arterial disease and intermittent claudication.
View Guideline

New Guideline for Optimal Perioperative Management of the Geriatric Patient
The American College of Surgeons National Surgical Quality Improvement Program and the American Geriatrics Society provides guidance on managing the older adult during the perioperative period.
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Updated Guidelines on Antithrombosis for Venous Thromboembolism
The American College of Chest Physician states that patients with unprovoked proximal deep vein thrombosis or pulmonary embolism who are stopping anticoagulation should receive aspirin to reduce the risk for recurrent venous thromboembolism.
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New 2015-2020 Dietary Guideline for Americans Released
The United States Departments of Health and Human Services and of Agriculture recommends limiting added sugars to less than 10% of calories, sodium to less than 2300 mg per day for those aged 14 and older, and saturated fats to less than 10% while avoiding trans fats.
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Updated 2016 Guideline for the Management of Candidiasis
The Infectious Diseases Society of America has updated guidelines with revised recommendations for diagnosing, preventing, and treating proven or suspected invasive candidiasis with relevance to pediatrics.
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Proposed 2016 Guideline Available for Prescribing Opioids for Chronic Pain
The Centers for Disease Control and Prevention recommends prescribing no more than 3 days of opioids for treatment of acute, non-traumatic pain unrelated to major surgery amongst 12 recommendations for clinicians prescribing opioids.
View Here | View Guideline
University of Louisiana at Monroe
School of Pharmacy

Drug Information Center


          Online Drug Information Requests

The Louisiana Drug Information Center (DIC) is located on the first floor of the School of Pharmacy in the Bienville Building of the University of Louisiana at Monroe.
As a courtesy to healthcare professionals, we provide drug information services pertaining to the following areas:

Adverse Drug Events
Availability of Products
Complimentary and Alternative Medicine
Clinical Kinetics
Drug Dosage and Scheduling
Drug Identification
Drug Interactions
Drug Regulations/Laws
Drug Use Evaluation Support
Institutional Review Board Support
Investigational/Foreign Drugs
IV Compatibility
Laboratory Interpretation
Pharmacy and Therapeutics Committee Support
Pregnancy and Lactation
Product Compounding
Therapeutic Drug Monitoring
Therapeutic Uses/Drugs of Choice
Travel/Health Information

The DIC provides information services to the healthcare professionals of the State of Louisiana. Additionally, this service is available to Medicaid providers through support from the Louisiana Medicaid Pharmacy Benefits Management Program.

Please contact us for assistance with your drug information needs by any of the following:
          Phone:  318-342-5501
          Online Drug Information Requests

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Disclaimer: No information source can replace clinical judgment applied to a specific case. Some of the drug therapy we write about will be outside the labeled indications for specific products. References will be provided when possible. Consult these references, product labeling, and/or give us a call if we can help with specific cases. This newsletter is supported by the University of Louisiana at Monroe School of Pharmacy and is not intended for commercial promotion.

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