September 2015 Issue of FYDI - For Your Drug Information
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Co-edited by:
Pharm.D. Candidates: Gina Helvey & Catherine Pham
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...

Recall on Miracle Diet 30 and Miracle Rock 48 Capsules
A voluntary recall is being issued on Miracle Diet 30 and Miracle Rock 48 Capsules. These capsules are manufactured by The One Minute Miracle Inc.  The recall is due to the presence of undeclared ingredients in the two formulations – phenolphthalein and thiosildenafil. 
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Invokana and Invokamet – FDA Drug Safety Communication
Invokana and Invokamet (canagliflozin) are type 2 diabetes medication.  The FDA has added new data elaborating on the increase risk of bone fractures. Both drug labels have a new warning and precaution, and both have revisions in the adverse reactions section.
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Voluntary Recall on Medistat RX Sterile Drug Products
A voluntary recall has been implemented on non-expired drug products for sterile use manufactured by Medistat RX.  This recall was issued after an inspection was completed and investigators questioned the sterility of the drug products. 
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Class I Recall on Puritan Bennett 980 Ventilators
A Class I Recall was issued on Puritan Bennett 980 Ventilator Systems manufactured by Covidien.  The recall is due to the system not functioning correctly and dispensing less oxygen than programmed.
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Class I Recall on Evita V500 and Babylog VN500 Ventilators
A Class I Recall was issued on Evita V500 and Babylog VN500 Ventilators manufactured by Dräger Medical.  The recall is due to a defect in the system’s battery indicator, which cannot indicate if a battery is low or depleted.
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FDA Drug Safety Communication on DPP-4 Inhibitors
The FDA is issuing a warning that DPP-4 inhibitors (i.e. sitagliptin, saxagliptin, linagliptin, and alogliptin) may cause severe and disabling joint pain.  The FDA has added this to the labels of all dipeptidyl peptidase-4 inhibitors, as a drug class warning and precaution.
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Recall OmniPod Insulin Management System
Insulet Corporation voluntarily recalled lot specific boxes of their OmniPod (Pod) Insulin Management System.  The recall was issued due to the possibility of higher rates of failure than the current standard set by Insulet.  The affected lots were distributed from December 2013 to March 2015.
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Class I Recall on Alaris Syringe Pump
A Class I recall is being issued on Alaris Syringe Pump model number 8110, which is used for the infusion of fluids and medications.  The manufacturer, CareFusion, has received 108 reports stating that the syringe has been malfunctioning.  The syringe activates a visual and audible alarm that causes the pump to stop.
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Class I Recall on Alaris Medley Large Volume Pump
A Class I recall is being issued on Alaris Medley LVP, which is used for the infusion of fluids and nutrients.  Elite Biomedical Solutions, the makers of this pump, found that the frame membrane of the device may be faulty.  This may lead to the under infusion of liquids or nutrients needed.
 View Here
Class I Recall on Hudson RCl Sheridan Sher-I-Bronch Endobroncial Tube
A Class I recall is being issued on Teleflex Medical’s endobroncial tubes.  Customers of Teleflex Medical have issued complaints about defects their tubes’ double swivel connectors.  Some of these tubes are cracking or separating from the rest of the device.  This may lead to hypoxia or respiratory distress.
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Refresh Lacri-Lub, Refresh P.M., Fluorometholone Ophthalmic Ointment (FML), and Blephamide Voluntarily Recalled for Particulate Matter
Allergan is voluntarily recalling specific lots of Refresh Lacri-Lube 3.5 and 7 g for dry eye, Refresh P.M. 3.5g for dry eye, FML 0.1% 3.5g, and Blephamide (sulfacetamide sodium and  prednisolone acetate ophthalmic ointment) 10%/0.2% 3.5g for particulate matter found in the product after breaking off from the cap.
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View Specific Lots Recalled Here
FDA Drug Safety Communication – Picato Requires Label Changes Due to Adverse Reactions
The FDA is requiring the makers of Picato gel (ingenol mebutate) to add new warnings on the safety risks and additional instructions on the safe and proper use of this product.  Recent reports showed that some users had severe allergic reactions and shingles linked to the use of this product.  Several eye injuries and skin reactions were also reported.
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FDA Warning: Compounded Drugs Stored in 3ml and 5ml Syringes Manufactured by Becton-Dickinson
The FDA notified healthcare professionals to stop the administration and storage of compounded or repacked drugs in 3ml and 5ml Becton-Dickinson syringes, unless there is no appropriate alternative.  The rubber stopper in these syringes may have a possible interaction with the medications, which cause these drugs to lose their potency overtime.  Becton-Dickinson is also issuing an alert for their 10ml, 20ml, and 30ml syringes as a precaution.
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Class I Recall on OxyTOTE Portable Oxygen Unit
The FDA recalled OxytTOTE portable oxygen units after the company received reports of ignition/combustion of the canisters when dropped or mishandled.  Western/Scott Fetzer Company received two incidence reports of these canisters malfunctioning, which lead to one injury and one death. 
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Recall: Sterility Concerns on Prolotherapy with Phenol Manufactured by Hartley Medical
Hartley Medical is voluntarily recalling three lots of Prolotherapy with Phenol.  This voluntary recall is a precaution due to recent concerns raised after an inspection of this product’s sterility methods and testing procedures.
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FDA Safety Communication – Quality Problems with Mammograms at Boston Diagnostic Imaging
Boston Diagnostic Imaging in Orlando, FL had a clinical image review done by the American College of Radiology (ACR) due to accreditation purposes.  The ACR found deficiencies in clinical cases that were submitted by the facility for review.  The facility’s mammogram accreditation was revoked in July 29, 2015, and the FDA is notifying patients who had mammograms on or after May 13, 2013.
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Update: July 2015 Drug Safety Labeling Changes
The FDA has provided a list of medications that have undergone labeling revisions due to safety concerns.
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Recall Update: Sterile Human and Veterinary Compounded Drugs by Moses Lake Professional Pharmacy
FDA held a firm press release on the completed list of affected drugs involved in the Moses Lake Professional Pharmacy scandal. In July 2015, the pharmacy voluntarily recalled unexpired human and veterinary sterile compounded drugs due to sterility issues.
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Cook Medical’s Beacon Tip Angiographic Catheters Undergoing Class I Recall
Catheter tip may split or separate from the catheter, potentially causing serious injury.
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FDA Warns of Serious Adverse Events Associated with Left Ventricular Assist Devices (LVADs)
The Thoratec’s HeartMate II has been associated with an increased rate of blood clots inside the pump, and the HeartWare HVAD has a higher incidence of stroke reported. Both devices have bleeding complications related to them.
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Gilenya : Drug Safety Communication – Cases of Rare Brain Infection
The FDA is issuing a warning for the drug Gilenya.  Two cases of progressive multifocal leukoencephalopathy (PML), one confirmed case and one probable, have been reported in patients currently taking the drug to treat multiple sclerosis.  The information about both cases will appear on the drug label.
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Duodenoscope Reprocessing: FDA Safety Communication - Supplemental Measures to Enhance Reprocessing
The FDA is issuing a comprehensive list provided by an agency-led expert panel that highlights supplemental duodenoscope reprocessing measures.  This list will be used in conjunction to manufacturer reprocessing instructions to aid in the reduction of infection risk and increase the safety of the duodenoscope.
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Voluntary Recall of Hydrochlorothiazide Tablets by Unichem Pharmaceuticals
One lot of hydrochlorothiazide tablets has been voluntarily recalled as a precautionary measure. Another drug, clopidogrel, has been identified in a bottle of the product. Affected tablets include Lot # GHYL15028 – Expiration April, 2018. This lot of bottles was distributed from May 21-28, 2015.
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Baxter Voluntarily Recalls One Lot of 0.9 Percent Sodium Chloride Injection
One lot of solution is being recalled due to the potential for leaking containers, particulate matter, and missing port protectors. These three things can lead to contamination of the solution. This recall affects the following lot Number: C964601, NDC: 0338-0049-03; Expiration Date: 04/30/2016 distributed between January 22, 2015 and February 12, 2015. 
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News Items...

Resveratrol Linked to Treatment of Alzheimer’s Disease
Resveratrol is an antioxidant found in grapes, chocolate, and red wine.  A new study claims that concentrated doses of resveratrol may help in slowing the progression of the disease.  These claims still need more clinical data, and a phase 3 clinical trial may start as soon as next year. 
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Anti-inflammatory Medications Linked to Lowering Risk of Colon Cancer
New research found that individuals who are on anti-inflammatory medications for five years or more may reduce their risk of colon cancer.  Low-dose aspirin has shown a decrease in the risk of colon cancer by 27%, and NSAIDS are linked to a 30-45% decrease.
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Beta Blockers Associated with Increase Survival in Cancer Patients
A retrospective study was done on women with ovarian cancer.  The study indicated that the participants on a specific type of beta blocker lived four years longer than the average of those not exposed to the medication.
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Generic Baraclude Released by Camber Pharmaceuticals
Camber Pharmaceuticals announced that they will be releasing a generic version of Bristol-Myers Squibb’s Baraclude, which is used to treat chronic hepatitis B.  The generic, Entecavir, will come in 0.5mg and 1mg tablets.
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FDA Fast Tracks Solithromycin to Treat Community Acquired Bacterial Pneumonia (CABP).
Solithromycin is in Phase III development for the treatment of CABP and a New Drug Application submission is planned for 2016. The drug will be available IV and in capsules.
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Studies Show That Modafinil May Be a “Smart Drug”
Modafinil, also known as Provigil, was originally approved by the FDA for the treatment of sleep disorders, like narcolepsy.  Recent studies on non-sleep-deprived persons showed enhanced cognitive function.
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Valeant Pharmaceuticals Offers to Buy Female Libido Pill for $1 Billion
Two days after Addyi was approved by the FDA, Valeant Pharmaceuticals offered Sprout Pharmaceuticals $1 billion for the pill.  Valeant is paying $500 million upfront and will pay the remainder after the deal closes in the first quarter of 2016.  Sprout Pharmaceuticals projects that the pill will be available on the market by October 17.
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Expanded Label for Procysbi Includes Children Aged 2-6 Years with Nephropathic Cystinosis
FDA approved expanded use of Procysbi (cysteamine bitartrate) in 2 to 6 year olds to treat nephropathic cystinosis, a rare metabolic lysocomal storage disorder. The decision came from efficacy and safety data from a study that treated that age group with Procysbi for 12 months.
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FDA Approves Premixed Cefazolin to Help with Drug Shortage
Cefazolin’s high demand has put it on the FDA’s drug shortage list for over a year. A frozen premixed Cefazolin 2 gram injection by Baxter and Water Street has been approved by the FDA to help counter this demand. Baxter is aiming to launch the injection in the fourth quarter this year.
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FDA Accepts New Drug Application (NDA) for Ophthalmic Solution for Use Post-Cataract Surgery
InSite Vision Inc. develops ophthalmic products for unmet eye care needs. The FDA has accepted their NDA for BromSite (0.075% bromfenac) to treat inflammation and prevent ocular pain after cataract surgery. The drug combines bromfenac with InSite Vision’s DuraSite platform to extend the time the drug stays in contact with the eye. In Phase 3 trials, BromSite accomplished statistically significant superiority than other vehicles and was well tolerated with no significant safety issues.
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Development of Screening Test to Diagnose Toddlers with Autism
At the University of Massachusetts Medical School, researchers have constructed a screening test to aid in the diagnosis of autism in toddlers.  The chance of earlier detection can lead to immediate intervention and help toddlers with autism adapt to society.
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Prenatal SSRI Exposure Linked with Lower Preterm Births and Caesarean Sections
Researchers used the national Finnish registry to collect data on live births between 1996 and 2010. The analysis concluded that SSRI exposure decreased the risk of late preterm birth, very preterm birth, and for cesarean section. There appeared to be no association with higher rates of congenital abnormalities, but SSRI use led to poor neonatal adaptation, including weaker breathing, heart rate, and muscle tone after birth.
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FDA Warns Multiple Manufacturers of Medical Devices after Outbreak of Superbug
The FDA sent warning letters to Olympus Corp, Pentax Medical, and Fujifilm Holdings Corp after medical devices created by these companies were linked to a recent superbug outbreak. 
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Aspirin Reduces Risk of Bowel Cancer in the Obese
Researchers have found that aspirin may reduce the risk of bowl cancer in obese people with Lynch Syndrome.  Researchers suggest that this may be beneficial for society as a whole.
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Organ Transplant May Increase the Risk of Melanoma
Researchers found that organ transplant recipients have an increased risk of melanoma double that of the normal population.
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FDA Approves OxyContin Use in Children 11 and Older
The FDA requested studies on OxyContin use in pediatrics, and the evidence supported the addition of a pediatric indication to the OxyContin label for those 11 to 16 years old. Currently, Duragesic (fentanyl) is the only other extended-release opioid product with FDA-approval for pediatric use.
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FDA Accepts New Drug Application for Treating Chorea Associated with Huntington Disease (HD)
Teva’s New Drug Application for deutetrabenazine (SD-809) was accepted based on encouraging data from two phase 3 studies, FIRST-HD and ARC-HD. First-HD showed reduction of chorea in HD patients, and ARC-HD demonstrated safe conversion from tetrabenazine to deutrabenazine overnight with continued chorea control. Tetrabenazine is the only FDA-approved HD treatment.
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GlaxoSmithKline Deems Medications Produced from Plant with Legionnaries’ Disease Safe
GlaxoSmithKline’s pharmaceutical plant in Zebulon was closed temporarily after the discovery of Legionella pneumophila bacteria, which is known to cause Legionnaries’ disease.  The company states that the medications were not compromised and the plant will reopen soon.
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Scientists Use Bioengineered Baker’s Yeast to Make Opioids
A quick method was invented by scientists to produce potent opioids using bioengineered baker’s yeast.  Scientists are currently working on perfecting the method for commercial use.
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Pharmacy Technician’s Awareness Leads to Drug Recall
In late March, Tashia Cox-Martinez found a vial of bupivacaine hydrochloride injection that had a brownish discoloration and metal particles embedded inside.  Her observation eventually leads to a drug recall.
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The Percentage of Uninsured Rates Decreases Below 10% for the First Time
According to the Center of Disease Control and Prevention, the national rate of the uninsured stood at 9.2% at the beginning of this year.
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Tropical Diseases Slowly Invading America
The Smith Clinic in Houston transforms one of its wings into a tropical medicine clinic for a half a day each week.  Since it has opened in 2011, doctors have treated cases of dengue, chikungunya, leishmaniasis, and recently a case of Chagas disease.  Tropical diseases have become so prevalent that Baylor College of Medicine in Houston has founded a school of tropical medicine.
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Gene Variant Linked to Graft Vs. Host Disease (GVHD)
Allogeneic stem cell transplant recipients with increased expression of HLA-DPB1 gene have an increased risk of GVHD. Patients with the high-expression rs9277534G allele had a 54% greater risk of GVHD compared to patients with the low-expression rs9277534A allele.
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GlaxoSmithKline’s Big Clinical Trial to Prove Breo Can Enhance Lifespan of Chronic Lung Disease Patients
Data from a SUMMIT study showing that Breo can prolong the lives of chronic lung disease patients should be released sometime next month.  There are currently no studies that link any inhaled drugs with an increase survival rate.
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Scientists Cultivate Monkey Cells into Limbs in Hopes of Fabricating Human Limbs for Transplantation in the Future
U.S. scientists have isolated cells from a monkey’s arm in order to reproduce a bio-limb inside of a lab.  This technique has been successfully completed on rats, and scientists look forward to the prospect of creating human bio-limbs.
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Medicare Will Pay More for Amgen’s Expensive New Leukemia Drug
Blincyto (blinatumomab) costs about $178,000 for a standard treatment course. Previously Medicare would not pay extra for the drug, but now it will allow a “new technology add-on payment” to hospitals up to $27,000 starting October 1.
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Drug Approvals...

FDA Approves Extended-Release Aspirin for Secondary Prevention in High-Risk Cardiovascular Disease Patients
Durlaza is a special formulation of aspirin that releases the drug in a manner designed to provide a stable antiplatelet effect over the course of a day, since platelets are generated throughout the day. Current immediate-release aspirin only stays in the blood for about 4 to 6 hours.
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First Drug Approved to Treat Hereditary Orotic Aciduria
The FDA approved Xuriden (uridine triacetate) for the treatment of hereditary orotic aciduria, a rare metabolic disorder. This disorder is inhereited from a recessive gene and has been reported in around 20 patients worldwide. These patients are deficient in the enzyme that synthesizes uridine, a necessary component of RNA. Xuriden is approved as oral granules that can be mixed with food or in milk or infant formula once a day.
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FDA Approves Varubi for the Treatment of Chemotherapy-Induced Nausea and Vomiting
Varubi (rolapitant) is used to prevent delayed phase chemotherapy-induced nausea and vomiting, and can be used in combination with other antiemetic agents. The drug prevents the activation of NK-1 receptors, which play a central role in emesis. It will be available in tablet form and will be contraindicated in certain medications because it inhibits the metabolizing enzyme, CYP2D6.
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FDA Approves Combination Product, Synjardy, for Treatment of Adults with Type 2 Diabetes.
Synjardy combines a sodium glucose co-transporter-2 (SGLT2) inhibitor, empagliflozin, and a biguanide, metformin, for treating type 2 diabetes. The drug contains a Black Box Warning for lactic acidosis.
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FDA Approves Repatha, the Second Approved Drug in New Class of Cholesterol Lowering PCSK9 Inhibitors.
Repatha (evolocumab) makes the second FDA approved drug in two months in a new class of cholesterol lowering PCSK9 inhibitors. It is approved for use in addition to diet and maximally-tolerated statin therapy in adults with heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH), or clinical atherosclerotic cardiovascular disease who require additional lowering of LDL cholesterol.
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First Treatment for Sexual Desire Disorders Approved
The FDA approved the first female sexual desire disorder medication manufactured by Sprout Pharmaceuticals.  Addyi (flibanserin), approved to treat hypoactive sexual desire disorder (HSDD) in premenopausal women, will be available through prescription and will carry a black box warning for hypotension and syncope.
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Keveyis First Drug Product Approved for Primary Hyperkalemic and Hypokalemic Periodic Paralysis
Taro Pharmaceutical Industries Ltd.’s Keveyis (dichlorphenamide) has been FDA approved for treatment of a group of rare hereditary disorders that cause episodes of muscle weakness or paralysis. Primary periodic paralysis affects approximately 5,000 people in the United States.
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Spritam Approved as First 3D Printed Drug Product
Aprecia Pharmaceuticals Company’s Spirtam (levetiracetam) was approved by the FDA for as the first 3D printed drug product. It is used as an oral adjunctive therapy in the treatment of partial onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures in epileptic patients.
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Finacea Foam Approved for Topical Treatment of Rosacea
The FDA approved Bayer HealthCare Pharmaceuticals’s Finacea (azelaic acid) Foam, 15% to topically treat rosacea. The foam specifically treats the inflammatory papules and pustules found in the mild to moderate form of the condition. The drug will be available starting in September.
View Here



American College of Obstetricians and Gynecologists (ACOG) Updates Guidelines on Treating Morning Sickness
The ACOG have updated 11-year old guidelines for treating morning sickness. The guideline update suggests women pair vitamin B6 and doxylamine to treat persistent, disruptive morning sickness. These two medications are available OTC separately or together as a prescription product, Diclegis. The ACOG also pulled back their support on Zofran (ondansetron) use after reviewing recent data that suggests the drug may be linked to birth defects.
View Here
Abstract Here
CDC Releases 2015-2016 Influenza Vaccine Recommendations
The Advisory Committee on Immunization Practices updates recommendations for the 2015-2016 influenza season. Important updated information includes an updated algorithm for determining the appropriate number of doses for children aged 6 months through 8 years, and recommendations for the use of live attenuated influenza vaccine (LAIV) and inactivated influenza vaccine (IIV).
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American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) Release Updated Hepatitis C Guidelines
This guideline updates addresses various issues including HCV testing, therapy, and monitoring as well as information treating HIV/HCV coinfections. A free digital version of this guideline is available on iOS and Android as part of the Guideline Central App.
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iOS Guideline Central App
Android Guideline Central App
The American Diabetes Association (ADA) and the American Heart Association (AHA) Release Updated Statement on the Prevention of Cardiovascular Disease in Adults with Type 2 Diabetes
The scientific statement updates the 2007 statement with information from studies published since 2008 and guideline changes from each organization based on those studies. Topics included are HbA1c use to diagnose diabetes, aspirin use, blood-pressure management, and screening for complications.
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American Society of Clinical Oncology (ASCO) Updates Guideline on Hematopoietic Colony-Stimulating Factors (CSFs) Use
Update of the 2006 Clinical Practice Guideline on the use of CSF. Important changes include addition of Granix (tbo-filgrastim) and Zarxio (filgrastim-sndz) and moderation of CSF use in older patients with diffuse aggressive lymphoma. Updates were based on review of randomized clinical trials, meta-analyses, and systematic reviews conducted between October 2005 and September 2014.
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A New Guide for Using Rapid-Cycle Research to Reach Goals
The Agency for Healthcare Research and Quality (AHRQ) released a new guide to help researchers change the way their studies are conducted by altering the way primary care is provided.  They used practice-based research networks to help construct this guideline to improve the design of rapid-cycle research. 
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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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