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 March 2015 Issue of FYDI - For Your Drug Information
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Co-edited by:
Pharm.D. Candidates: Matthew Bullard & Deonte' Powell
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
          Email: druginfo@ulm.edu 
          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...


Hepatitis C Treatment Receives Change to Labeling
Revised product labeling will include that the coadministration of Sovaldi or Harvoni with amiodarone has demonstrated an increased risk of potentially life-threatening symptomatic bradycardia.
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Zyprexa Relprevv FDA Investigation Complete
The FDA has completed investigation of reports involving the deaths of two patients associated with injectable doses of Zyprexa Relprev, and is not recommending any changes to current prescribing or use of the product at this time.
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FDA Warns About OTC Asthma Products
The U.S. FDA has warned consumers on the efficacy of homeopathic OTC asthma products, as these products have yet to be evaluated for safety and effectiveness.
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Weight Loss Substance Recall
Ultra ZX labs has issued a voluntary recall for its weight loss supplement UltraZX after the product was found to contain undeclared amounts of sibutramine and phenolphthalein.
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FDA Warns About Treanda
The FDA is warning health care professionals about the compatibility issues of Treanda injections with closed system transfer devices, adapters, and syringes that contain polycarbonate or acrylonitrile- butadiene-styrene.
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FDA Updates Label for Chantix
The U.S. FDA has warned that Chantix may cause seizures when alcohol is consumed in conjunction with the smoking cessation drug.
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Hospira Recalls One Lot of Magnesium Sulfate in D5W
Hospira announced a recall of one lot of Magnesium Sulfate in 5% Dextrose, Inj., USP, 10 mg/mL due to an incorrect barcode on the primary bag labeling.
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Hospira Recalls One Lot of 0.9% Sodium Chloride for Injection
Hospira announced that one lot of Sodium Chloride for Injection has been voluntarily recalled due to particulate matter.
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FDA Strengthens Next Year’s Flu Vaccine
Two new strains will be included in next year’s vaccine to counter the viral drift encountered during this year’s flu season.
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FDA Provides New Mobile App
The FDA launched its first mobile app that is specifically designed to speed public access to information about drug shortages.
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FDA Warns on Testosterone Products
The FDA has directed that testosterone manufactures adjust the labeling on all testosterone products in order to clarify the correct usage and indications, which will include new data on increased risk of myocardial infarctions and strokes.
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Montelukast May Have More Adverse Drug Events
The FDA has alerted healthcare professionals that there may be more neuropsychiatric and suicidality concerns with montelukast that have gone underrecognized.
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Heritage Pharmaceuticals Inc. Recalls Products
Heritage Pharmaceuticals Inc. has issued a voluntary recall on 10 lots of colisteimethate for injection and 3 lots of rifampin for injection due to a lack of sterility assurance.
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Atracurium Besylate Injection - Nationwide Recall
Two lots of atracurium besylate injections are under voluntary nationwide recall by Sagent Pharmaceuticals, Inc. due to product sterility issues.
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Ketorolac Tromethamine Injection Recalled Due to Particulate in Glass Vial
Hospira announced a voluntary recall on lots administered in the United States from February 2013 – December 2014.
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News Items...


TB Rate in the U.S. Slowly Declining
According to the CDC, the percentage decrease in tuberculosis rate is the smallest in over a decade.
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U.S. DEA Warns About Fentanyl
The Drug Enforcement Agency (DEA) stated in a nationwide alert that Fentanyl and Fentanyl analogues/compounds are becoming a more serious drug abuse issue due to heroin lacing.  
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Folic Acid May Reduce Stroke Risk in Certain Patient Population
Supplementation of folic acid may reduce the risk of stroke in adults with hypertension and a low serum folate level as shown in a recent study.
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FDA Approves Watchman Device
Boston Scientific announces that the Watchman Device has received approval for stroke prevention in patients with atrial fibrillation who have had difficulties with warfarin therapy.
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Andexanet Alfa Phase III Trial Shows Xarelto Reversal
Portola Pharmaceuticals’ Andexanet Alfa has been shown to reverse the effects of Xarelto (rivaroxaban) within five minutes of administration completion.
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Valcyclovir May Reduce HIV-1 Levels
In a recent study, it was shown that valcyclovir, commonly used for herpes manifestations, reduced the HIV-1 levels in patients.
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AMA and CDC Join Forces to Prevent Diabetes
The American Medical Association and Center for Disease Control have joined forces in order to attempt to identify more pre-diabetes patients under the slogan “Prevent Diabetes STAT”.
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TMP/SMX and Spironalactone Associated with Risk of Sudden Death
Concomitantly administering trimethroprim/sulfamethoxazole and spironalactone has been shown to carry an increased risk of sudden death in a recent study.
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FDA Offers Map for Generic Approval on 38 Drugs
FDA will release documents to make it easier for generic manufacturers to introduce competitive products that will provide competition to the drug market in an accelerated fashion.
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Drug Makers Support Efforts to Limit Copay for Patients
Drug makers are supporting efforts by patient advocacy groups to increase the number of states with laws limiting the patients' out-of-pocket expenses for expensive medications.
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Natural Product Used for Alzheimer’s Treatment Nears Clinical Trials
A natural product chemist from Michigan State University has received patent for a botanical compound, withanamides and through clinical trials will attempt to demonstrate evidence as the first natural product to treat Alzheimer’s disease.
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CVS Health Organizational Changes
CVS has implemented a series of organizational changes in order to stimulate the retail chain’s growth.
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Children’s Tylenol Manufacturer Pleads Guilty Over Metal Particles
McNeil Consumer Healthcare pleaded guilty in a federal criminal charge, which stated that the company sold OTC infant’s and children’s oral Tylenol products that contained metal particles.
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GADIS - Drug Information Resource
Global Alliance of Drug Information Specialists (GADIS) is a website/subscription service provided by the FDA for pharmacists and other healthcare professionals that promotes the advancement of public health and helps inform of new drug approvals, drug shortages, new medication guides, etc.
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Liraglutide May Help Adults Lose Weight 
A recent study to be presented at the Endocrine Society’s annual meeting showed that patients that received 3.0 mg of liraglutide along with fewer calories and increased physical activity were greater than twice as likely to achieve weight loss in accordance with the obesity guidelines.
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New Nasal Oxytocin Spray May Reduce Caloric Intake
A new nasal spray that is the synthetic form of Oxytocin may reduce caloric intake in men.  The study subjects, all men, ate fewer calories and fat after the spray was used.
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Statin Therapy May Benefit High Genetic Risk Patients
A Lancet study suggests that people with a high genetic risk for developing coronary heart disease benefit more from statin therapy.
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Goserelin May Aid Breast Cancer Chemotherapy
According to an International study in the New England Journal of Medicine, the gonadotropin-releasing hormone agonist, goserelin helps protect against ovarian failure in women undergoing chemotherapy for breast cancer.
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Female Fecal Incontinence Device - Marketing Approval
Pelvalon Inc.’s Eclipse System has been approved for use in women ages 18-75 with fecal incontinence.
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Test Helps Shorten Isolation for Suspected TB Patients
Expanded use of Cephid Xpert MTB/RIF Assay allows healthcare providers to use one or two negative test results to determine if a patient should remain in hospital airborne isolation.
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Adult Vaccination Rates Remain Low
Pneumococcal, tetanus and diphtheria with acellular pertussis (Tdap), herpes zoster, human papillomavirus, hepatitis A, and hepatitis B vaccination rates in adults in 2013 were analyzed by the CDC and found to remain below the Healthy People 2020 targets.
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FDA Ok’s First Continuous Glucose Monitoring App
The FDA marketed the first set of mobile medical apps, which will allow patients to securely share information from a continuous glucose monitor.
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Drug Approvals...


FDA Approves Cholbam
The FDA approved Cholbam (cholic acid) for the treatment of adolescent and adult patients with bile acid disorders that include enzyme defects and peroxisomal disorders.
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FDA Approves Asenapine for Bipolar I Disorder in Children
Asenapine has received approval as monotherapy for the treatment of acute manic or mixed episodes of associated with Bipolar I in ages 10-17 years.
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FDA Approves High-Risk Neuroblastoma Treatment
Unituxin (dinutuximab) has been approved by the FDA as part of first-line therapy in the treatment of high-risk neuroblastoma for pediatric patients.
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FDA Approves CPR Devices
The FDA has approved a ResQCPR System that consists of two devices for first responders while performing cardio-pulmonary resuscitation (CPR), which reportedly may increase the chances of surviving cardiac arrest.
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Antifungal Drug, Cresemba Approved
The FDA has approved Cresemba (isavuconazonium sulfate) which is a new antifungal drug used to treat adults with invasive aspergillosis and mucormycosis.
View Here
 
First Biosimilar Product, Zarxio Approved by FDA
Zarxio (filgrastim) is a biosimilar product referenced from Neupogen (filgrastrim) and has been approved for the same indications as Neupogen.
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FDA Approved New HIV Medication
The FDA approved a new HIV medication, Dutrebis (lamivudine and raltegravir) to be used in conjunction with other antiretrovirals.
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FDA Approved New Insulin Injection
Toujeo, long-acting human insulin, was approved by the FDA for the treatment of diabetes mellitus.
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FDA Approves New Lung Cancer Drug
The U.S. FDA has approved Opdivo (nivolumab) to treat patients with advanced squamous non-small cell lung cancer.
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Avycaz Approved by FDA
The FDA approved Avycaz (ceftazidime-avibactam), a new antibacterial drug product indicated to treat adults with complicated intra-abdominal infections.
View Here
 
Farydak Approved for Multiple Myeloma
Farydak (panobinostat) has been approved for the treatment of patients with multiple myeloma.  
View Here
 
FDA Approves Lenvima
Lenvima (lenvatinib) has been approved to treat patients with progressive, differentiated thyroid cancer.
View Here
 
Lucentis Approved for Diabetic Retinopathy Treatment
Lucentis (ranibizumab injection) has been approved by the FDA for once-monthly use to treat diabetic retinopathy in diabetic macular edema patients.
View Here
 

Guidelines...


WHO Releases First Hepatitis B Guideline
The World Health Organization has released its first set of guidelines for the prevention and treatment of chronic hepatitis B.
View Here
 
Adult CDC Immunization Guideline
The Center for Disease Control and Prevention has presented the latest vaccination schedule for adults.
View Here
 
Guideline for Pressure Ulcer Prevention and Treatment
The American College of Physicians has released evidence- based guidelines on preventing and treating pressure ulcers.
View Here
 
2015 Atrial Fibrillation Guidelines Update Released
Revised A-fib guidelines published in coordination with the American College of Cardiology, American Heart Association, Heart Rhythm Society, and in collaboration with the Society of Thoracic Society.
View Here

New Dietary Guidelines - Limit Sugar, Not Cholesterol
Removed recommendation of limitations of cholesterol but limit added sugars to <10% of calories, saturated fats<10% of calories, and sodium to <2300 mg.
View Here
 
2015 Childhood and Adolescent Immunization Schedule
The CDC’s Advisory Committee on Immunization Practices (ACIP) has published an updated annual immunization schedule for children and adolescents for 2015.
View Here
 
University of Louisiana at Monroe
School of Pharmacy

Drug Information Center

         318-342-5501
          druginfo@ulm.edu
          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
Pharmacoeconomics
Pharmacy and Therapeutics Committee Support
Pregnancy and Lactation
Product Compounding
Therapeutic Drug Monitoring
Therapeutic Uses/Drugs of Choice
Toxicology
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
          Email: druginfo@ulm.edu
          Online Drug Information Requests

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University of Louisiana at Monroe School of Pharmacy
Drug Information Center
View previous issues of the FYDI newsletter.
Please send your comments and suggestions to 
druginfo@ulm.edu.

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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