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Recall of 0.9% Sodium Chloride Injection, USP (AUTO-C)
Baxter international issued a voluntary recall of lot number C964601 due to leakage, particulate matter and missing port for items distributed between January-February 2015. View Here
Simbiq Infusion System Could Be Remotely Accessed By Unauthorized Users
A concern about cybersecurity has surfaced for the drug infusion system by Hospira. If accessed by the wrong person, different doses of medicine needed by patients could be altered with potentially life-threatening results. View here
Unichem Pharmaceuticals Recall Lot of Hydrochlorothiazide Tablets
After a clopidogrel tablet was found in one of the 1000 count bottles, concerns about replacing a dose of a blood pressure drug with that of an anti-platelet drug warranted a recall of the lot. View here
Brintellix Versus Brilinta: Confusion Due to Name Similarity
The FDA is recommending the generic names vortioxetine or ticagrelor be included when prescribing these drugs to avoid error and patients are encouraged to double check to make sure they are taking the correct medication. View here
Voluntary Recall Issued Concerning Six Lots of Adrucil
Issued by manufacturer Teva Parenteral Medicines, the fluorouracil injections from these lots may contain silicone rubber pieces as well as fluorouracil crystals. View here
Gadolinium-Based Contrast Agents Leaving Long Term Brain Deposits
The FDA is investigating these contrast agents commonly used in magnetic resonance imaging (MRI). For patients receiving multiple MRI scans, the risk of brain deposits is concerning and use may need to be limited. View here
Moss Lake Professional Pharmacy Voluntarily Recalls Compounded Medications
Lack of sterility assurance of only sterile human and veterinary compounded products prepared and distributed to 6 states between July 21, 2014 and July 21, 2015, a voluntary recall is in effect. View Here
Baxter Recall of Intravenous 0.9% Sodium Chloride Affects 2 Lot Numbers
Particulate matter was found in 50mL and 100mL 0.9% Sodium Chloride Injection, USP; lot numbers P319921 and P327635 were distributed between October 7, 2014 and July 14, 2015. View Here
Proglycem May Cause Pulmonary Hypertension in Infants and Newborns
Used as a treatment for low blood sugar, the FDA is warning parents and caregivers to be watchful for any signs of difficulty breathing while on the medication. View here
Prefilled Calcium Chloride Intravenous Syringe Withdrawn
Prefilled 10% w/v calcium chloride IV Infusion syringes by Mylan have been withdrawn from the market due to issues with administering the medication. View Here
Label Revision Strengthens Warning for Non-Aspirin NSAIDs Use
Over-the-counter and prescription labeling will reflect updated warnings and more detailed information on the increased risks of heart attack or stroke. View here
Lifesaver Single Patient Use Manual Resuscitator Class I Recall
The intake port on this medical device for acute respiratory use may become blocked, which would prevent breathing support to the patient. View here
FDA Evaluating Codeine Safety in Children Under 18
Using codeine preparations for the treatment of cough and cold in this demographic could bring about serious side effects, such as slowed or difficult breathing. View here
Announcement Regarding Prescription Otic Drops With Unapproved Ingredients
The FDA intends to take action against manufacturers and distributors of otic products with unapproved ingredients. View here
Daytrana Patch Causing Permanent Skin Color Changes
The transdermal system is receiving a new warning to the labeling due to reports of the adverse event, chemical leukoderma. View here
FDA Backs 2013 Labeling of Drug Potiga
Though the FDA supports current labeling, the Administration is requiring further investigation from the manufacturer of the anti-seizure drug, Potiga (ezogabine) due to several safety reports concerning potential vision loss and skin discoloration. View here
Mylan Expands Voluntary Recall Due to Products Containing Visible Particulate Matter
The recall from late April of this year has been expanded to the hospital and user levels. These parties will receive a letter regarding the return of gemcitabine, carboplatin, methotrexate, and cytarabine injectable products. View here
Vascu-Guard Peripheral Vascular Patch Undergoing Class I Recall
Complaints have been raised concerning the ambiguity between the smooth and rough surface of the patch, as incorrect application could result in vessel thrombosis and/or embolism. View here
Updating Labeling of Soft Tissue Fillers
Unintentional injection of these dermal fillers into facial blood vessels could cause blockages, cutting off blood supply that could lead to a host of adverse events. View here
FDA Warns of Potential Dosing Errors of Zerbaxa
Due to the listing of the individual ingredient strengths, there was increased margin for error in dispensing the incorrect amount. View here
SGLT2 Inhibitor Use May Lead To Ketoacidosis
The FDA warns that the use of this class of Type 2 Diabetes medications, including canagliflozin, dapagliflozin, and empagliflozin, could result in ketoacidosis. View here
Study Reveals High Blood Pressure Connection to Dietary Sodium Intake
Urinary sodium levels were studied in Japanese adults to estimate dietary sodium consumed and a possible link to the development of high blood pressure. View Here
Malaria Vaccine Approved in Europe
GlaxoSmithKline plans to roll out a new malaria vaccine, Mosquirix, with plans for a launch in Africa. View Here
Balloon Device for Obesity Approved as a First in the U.S.
The new device is inserted for a period of up to six months and works by bringing about feelings of being full. The ReShape dual balloon system is only a 30 minute procedure. View here
Dengue Vaccine Useful in Older Children
Phase III trials showed reduced dengue disease in children receiving the vaccine although safety concerns have been raised in children under 9 years old. View Here
Studies Suggests Starting Statin Therapy Sooner
Two studies suggest that it may be best to widen the statin patient eligibility to prevent more myocardial infarctions and strokes. View here
FDA Extended the Deadline for Posting Product Calories For Restaurants
In line with the Affordable Care Act, the FDA is requiring all chains with at least 20 outlets to post their respective calorie counts in plain sight. Originally set for the end of this year, that deadline has been pushed back until the end of 2016. View here
Anticholinergics Possibly Linked to Pneumonia Risk in Older Adults
This go-to class of drugs for many older adults may need to be used sparingly in order to avoid more serious risks. View here
Student-Operated Pharmacy to be Launched in New York College
Albany college plans to train their students for the real world while still in school so they will be prepared and ready come graduation. View here
Generic Targrentin (Bexarotene) Now Available
Individuals suffering with cutaneous t-cell lymphoma refractory to other therapy, now have a generic option available thanks to Mylan announcing the generic version of Targretin 75mg capsules. View Here
CDC Study Suggests Paxil and Prozac Possibly Linked to Birth Defects
Using combined data from multiple studies, researchers found that among all selective serotonin reuptake inhibitors (SSRIs), only Paxil and Prozac demonstrated a possible link to birth defects. View here
Hereditary Angioedema Prevention Product Receives Breakthrough Therapy Designation
Human monoclonal antibody, DX-2930 is being investigated by Dyax Corporation to prevent hereditary angioedema attacks and has received breakthrough therapy designation from the FDA to expedite further studies. View Here
Experimental Lung Cancer Drug Promising For Survival, Not Without Risk
In a clinical trial by Eli Lilly & Co, patients receiving Necitumumab for stage IV squamous non-small cell lung cancer had increased survival and increased risk of blood clots. View Here
Practitioners Develop Deprescribing Guidelines for Elderly
Using a modified Delphi approach, practitioners aim to curb inappropriate medication use in the elderly by prioritizing five classes of medications which can be deprescribed; included are benzodiazepine, atypical antipsychotics, statins, tricyclic antidepressants and proton pump inhibitors. View here
Wireless Drug Delivery Now Possible With Nanowire Drug Delivery
Using electromagnetic fields, these polymeric nanowires release a drug exactly where it is needed. This system could eventually be a viable new approach to drug delivery. View here
Dabigatran’s Novel Reversal Agent Investigated in Phase III Trial
A study in the New England Journal of Medicine reports the monoclonal antibody fragment Idarucizumab binds dabigatran with 350x higher affinity than thrombin resulting in complete and speedy reversal of the anticoagulation effects. View here
Daklinza Approved for Chronic Hepatitis C Genotype 3
Daklinza (daclatasvir) has been approved to use with sofosbuvir to combat the hepatitis C virus. This new drug does not have to be used concurrently with interferon or ribavirin. View here
Praluent Approved for Treatment of Familial Hypercholesterolemia
Praluent (alirocumab) is the first PCSK9 inhibitor approved by the FDA, and is indicated for adults with heterozygous familial hypercholesterolemia (FH) or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-cholesterol. View here
Odomzo Approved for Locally Advanced Basal Cell Carcinoma
Odomzo (sonidegib) is indicated for patients that are not candidates for surgical or radiation therapy or those with a recurrence of carcinoma after one of the aforementioned therapies. View here
Kyprolis Approved for Patients With Relapsed Multiple Myeloma
For patients having undergone 1-3 lines of prior therapy, Kyprolis (carfilzomib) can be used in combination with lenalidomide and dexamethasone for relapsed multiple myeloma. View here
Iressa Approved for Metastatic Non-Small Cell Lung Cancer
The recently approved medication, Iressa (gefinitinib) is indicated for tumors with epidermal growth factor receptors that have exon 19 deletions or have an exon 21 substitution mutation. View here
Rexulti Approved for Treatment of Schizophrenia
Starting in August, the drug Rexulti (brexpriprazole) will be available for schizophrenia treatment as well as adjunct therapy for major depressive disorder. View here
Flublok Influenza Vaccine Receives FDA Approval for Upcoming Flu Season
Manufacturers of the Flublok vaccine received the green light from the FDA for the new flu vaccine formulation and anticipate distribution in mid-August. View here
New Acetylcysteine Injection Available
FDA approved Akorn Pharmaceuticals Acetylcysteine Injection 6g/30mL single dose product. View Here
Anti-Epileptic Drug, Fycompa Approved as Adjunctive Treatment
In patients 12 years and older, Fycompa is approved for adjunctive treatment for primary generalized tonic-clonic seizures. View here
Cangrelor Approved as Anti-Platelet Medication During PCI
The FDA has approved Cangrelor for use to prevent clot formation during percutaneous coronary intervention (PCI). View here
New Medications for Irritable Bowel Syndrome with Diarrhea, Viberzi and Xifaxan
Viberzi is a twice a day drug which can reduce bowel contractions due to the new active ingredients. Xifaxan is taken three times a day for 14 days. View Here
Rapamune Approved for Treatment of Lymphangioleiomyomatosis (LAM),
Originally an immunosuppressive agent for organ rejection, Rapamune has shown to provide treatment for this rare, progressive lung disease which impacts women of reproductive age. View Here
Stioloto Respimat Approved for Maintenance of COPD
Boehringer Ingelheim received FDA approval for the release of the new once-daily long-acting beta2-adrenergic agonist inhaler for COPD patients requiring maintenance treatment of airflow obstruction. View Here
Invega Trinza Approved for Schizophrenia
The new extended release injectable suspension formulation has four times a year dosing regimen in the treatment of schizophrenia. Prior to initiating Invega Trinz, patients must be treated for a minimum of 4 months with Invega Sustenna. View Here
NDA for Tuzistra XR Approved for Cough, Cold and Allergies in Adults
The FDA has approved a new drug application (NDA) for this combination of codeine and chlorpheniramine extended release suspension, which offers 12 hours relief for the treatment of upper respiratory allergies, cough and cold symptoms. View here
Guideline Update for Vomiting in Infants Up to 3 Months of Age
The guideline assesses the different options of examining the infants. The options considered are x-ray, ultrasound, and reflux scintigraphy. View here
Guideline Update Concerning Unruptured Intracranial Aneurysms
The American Heart Association and the American Stroke Association have updated the 2000 guideline regarding the diagnosis and treatment of these aneurysms. View here
Guideline Summary Developed for Acromegaly In Clinical Setting
The Endocrine Society has developed a practice guideline for acromegaly patients. View Here
Update to Idiopathic Pulmonary Fibrosis (IPF) Guidelines
The American Thoracic Society includes new treatment options in the IPF treatment guidelines, such as the new FDA-approved agents, Esbriet (pirfendione) and Ofev (nintedanib). View here View abstract
Guidelines for Recurrent Kidney Stone Prevention Reevaluated
The American College of Physicians (APA) and the American Urological Association Education and Research, Inc. (AUA) are collaborating on recurrent kidney stone prevention to develop the guidelines. View here
CDC Updates Guidelines for Treatment of Sexually Transmitted Diseases (STDs)
The CDC has released this update to the 2010 guidelines for treatment, and for those that are at risk for STDs. View here
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:
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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.
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.
