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.
Voluntary Safety Notice of MitraClip Delivery System by Abbott
Abbott has released a safety notice regarding the MitraClip Delivery System to emphasize the appropriate procedures to operate and deploy this device due to reports of improper use that required surgical intervention. This delivery system is a device used to treat patients who have degenerative mitral regurgitation. View Here
UPDATE: Class 1 Recall, Beacon Tip Angiographic Catheters May Slip or Separate
This voluntary recall of a specific lot of these catheters has been updated to a Class 1 recall. If separation of the tip occurs, the tip could enter the patient’s bloodstream causing serious injuries. View Here
Cook Medical Recalls Central Venous Catheters and Pressure Monitoring Sets and Trays: Class 1 Recall
After discovering that Central Venous Catheters distributed globally from April 24, 2015 to October 23, 2015 had the potential to separate and/or fracture at the catheter tip, Cook Medical is recalling single lumen central venous catheter sets and trays, single lumen pressure monitoring sets, radial and femoral artery pressure monitoring catheter sets and trays. View Here
Device Slippage of Neurosurgical Head Holders
The FDA has received more than 1,000 medical device reports with over 700 injuries due to unintended movement or slippage associated with surgical clamps. There is no specific manufacturer or brand associated with these injuries. The FDA believes that the benefits outweigh the risk with these devices and suggests that health care providers should be aware of techniques for safe use. View Here
Update: FDA Provides Updated Information About Custom Ultrasonics Recall Order in November 2015
Since Custom Ultrasonics has not demonstrated that its Automated Endoscope Reprocessors can effectively wash and disinfect endoscopes to alleviate the risk of patient infection, the FDA continues to recommend that health care facilities using this device move to alternative methods of reprocessing flexible endoscopes immediately. View Here
FDA Safety Communication: Pentax Validates Reprocessing Instructions
Pentax has released an updated version of manual reprocessing instructions for the ED-3490TK Video Duodenoscope. After reviewing these updates, the FDA has recommended that facilities using this device train staff on these updated instructions. View Here
Baxter Recalls 0.9 Percent Sodium Chloride Solution for Irrigation
Baxter International has released a voluntary recall of 0.9% sodium chloride Irrigation 500 mL plastic pour bottle solution for LOT G120162. This recall occurred after a customer complaint was received about the presence of particulate matter identified as an insect. View Here
Recall of Super-potent Morphine Sulfate 0.5 mg/mL Preservative Free in 0.9 Percent Sodium Chloride.
The FDA is alerting health care professionals of a voluntary recall made by Pharmakon Pharmaceuticals. The company recall was released after several laboratory results showed the product was super-potent; shortly after, the FDA was alerted of serious adverse events in three infants associated with the use of morphine sulfate products by Pharmakon Pharmaceuticals. View Here
Update: Drug Safety Labeling Changes for January 2016
26 drug products have received safety labeling changes. View Here
FDA Alert for Microbial Contamination with Yeast in SyrSpend SF Agents by Fagron
Fagron has announced a voluntary recall for SyrSpend SF and SyrSpend SF Grape because of the presence of Candida galli found in certain lots of the suspending agent. View Here
Class I Recall for Oxylog Emergency Transport Ventilators by Dräger Medical
Dräger Medical is recalling Oxylog 2000 plus, Oxylog 3000, and Oxylog 3000 Plus Ventilator devices because of an electrical malfunction that may cause the device to stop working if the control knobs on the device have not been used recently. View Here
Voluntary Recall on Pink Bikini and Shorts on The Beach Dietary Supplements
Lucy’s Weight Loss System is voluntarily recalling all lots of their Pink Bikini and Shorts on the Beach Capsules to the consumers due to the FDA’s analysis of an undeclared active pharmaceutical ingredient. View Here
Risk of Lead Poisoning from Bentonite Clay Natural Products
The FDA is warning consumers not to use “Bentonite Me Baby” medicinal clay products indicated for oral and topical use for hair and skin conditions by Alikay Naturals, due to the risk of lead poisoning associated with the product. View Here
Risk of Mercury Poisoning from Crema Piel De Seda
The FDA is warning consumers not to use a skin whitening cream called “Crema Piel De Seda” manufactured by Viansilk due to the risk of mercury poisoning that can cause serious health problems. View Here
Class I Recall for SPOTCHEM II Test Strips by Arkray
Due to falsely low blood sugar readings that increase the risk of failure to treat elevated blood glucose levels in a timely manner, Arkay is recalling the SPOTCHEM II Reagent Test Strips. View Here
Class I Recall for St. Jude Medical’s Optisure Dual Coil Defibrillation Leads
Due to a manufacturing error that may have caused damage to the insulation layer of one of the shock coils that may cause serious injuries or death, St. Jude Medical is recalling Optisure Dual Coil Defibrillation Leads that are implanted wires that connect a defibrillator to a patient’s heart. View Here
Baxter Recalls Intravenous Solutions Nationwide
Due to the potential for leaking containers and particulate matter, Baxter is voluntarily recalling four lots of intravenous solutions including 0.9% Sodium Chloride Injection, Metronidazole Injection, and Clinimix E Injection that was distributed nationwide between October 9, 2015 and January 18, 2016. View Here
Iron Improves Newborns’ Development of Motor Skills
According to a randomized, controlled trial in China, infants that were given iron in their first year of life demonstrated improved motor development at 9 months of age. View Here
Does Flibanserin’s Benefits Outweigh the Risks?
A meta-analysis of 8 randomized trials suggested that the side effects of this hypoactive sexual desire disorder medication outweighs the efficacy it provides. View Here
Cohort Study: Fluoroquinolone Use Not Linked to Arrhythmias
An observational study demonstrated that oral fluoroquinolones, when compared with penicillin, was not associated with an increased risk of serious arrhythmias. View Here
2016 Flu Vaccine Virtually 60% Effective
The CDC reports the effectiveness of the current influenza vaccine is 59% this season, which is equivalent to past estimates when the viruses have been alike. View Here
AKI Risk Not Reduced with Statin Use
According to a new study, the use of high-dose statins before and after cardiac surgery does not reduce the risk of acute kidney injury (AKI). View Here
Vaccine Impacts HPV in Teenage Girls
HPV vaccine has significantly reduced the number of cases of four HPV strains among females ages 14-24, with a significantly greater decline in those ages 14-19. View Here
Benzodiazepine Drug Overdoses Increasing Significantly
The number of benzodiazepine prescriptions for the treatment of anxiety has significantly increased over the last several years, along with overdose mortality rate related to these drugs. View Here
Proton Pump Inhibitors Associated With Dementia
New study demonstrated that patients currently prescribed a PPI had a higher risk of dementia than patients not on a PPI. View Here
Discovery of New Lyme Disease Causing Bacteria Species
The CDC along with Mayo Clinic and other health officials have reported the discovery of a new bacteria species called Borrelia mayonii that can cause Lyme disease. B. mayonii is closely related to B. burgdorferi, the only species believed to cause Lyme disease, but does display a few differences in infection characteristics. View Here
Dr. Robert Califf and FDA Leaders Call for Review of Agency Opioids Policies
The FDA’s Deputy Commissioner for Medical Products and Tobacco and other FDA top officials have called for an action plan to reassess the agency’s approach toward opioid medications due to the current opioid abuse epidemic. View Here
Multistate Outbreak of Salmonella Linked to Meal Replacement Products
According to the Centers for Disease Control and Prevention, 11 people were infected with the multistate outbreak of Salmonella Virchow from consumption of powdered supplements or meal replacement powders prior to illness. View Here
Biosimilar Agent of Infliximab Effective in Treating Ankylosing Spondylitis
A multinational study found CT-P13, a biosimilar agent of infliximab (Remicade), to be equally effective as infliximab in rheumatoid arthritis for up to 2 years and comparable in Ankylosing Spondylitis at 30 weeks. View Here
Multistate Outbreak of Salmonella Poona linked to Cucumbers
The Centers for Disease Control and Prevention reported a high number of people continue to be infected with the multistate outbreak of Salmonella Poona linked to “slicer” cucumbers that are grown in Mexico and supplied by Andrew and Williamson Fresh Produce. View Here
Rescheduling of Hydrocodone Combination Products Reduced Prescriptions
After the U.S. Drug Enforcement Administration moved combination hydrocodone products from Schedule III to Schedule II, data shows that prescriptions for hydrocodone combination products fell while prescriptions for other opioid analgesics increased modestly. View Here
Addition of Cyclosporine A to Percutaneous Coronary Intervention
Study results support observations that cyclosporine A does not reduce reperfusion injury when given intravenously in addition to percutaneous coronary intervention. View Here
Neonatal Pain Prevention and Management Update
The American Academy of Pediatrics recommend clinicians and their institutions have existing and emerging evidence-based guidelines for infant pain management. View Here
FDA Approves Briviact for the Treatment of Partial Onset Seizures
Briviact (brivaracetam) was approved as a supplementary treatment by the FDA for the treatment of partial onset seizures in those ages 16 and older with the diagnosis of epilepsy. View Here
FDA Approves Harvoni to Treat Hepatitis C and Liver Disease
Gilead Sciences’ Harvoni (ledipasvir/sofosbuvir) is FDA approved for the treatment of chronic hepatitis C and advanced liver disease in adults. View Here
Zepatier Oral Combination Therapy Approved for Chronic Hepatitis C
The FDA approved Zepatier (elbasvir and grazoprevir) with or without ribavirin for the oral treatment of chronic hepatitis C virus genotypes 1 and 4 infections in adults. View Here
New Chemotherapy Shows Survival Benefit in Liposarcoma
Halaven (eribulin mesylate) is an FDA approved chemotherapy that has demonstrated an improvement in survival time for the treatment of unresectable or metastatic liposarcoma in patients who received previous chemotherapy containing an anthracycline drug. View Here
Managing Convulsive Status Epilepticus Guidelines
The American Epilepsy Society issues evidence-based guidelines on how to treat convulsive status epilepticus in adults and children. View Here
ACP Depression Treatment Guidelines for Adults
The American College of Physicians provides guidelines on treating adults with Major Depressive Disorder (MDD) with either pharmacologic or non-pharmacologic treatments based on patient factors. View Here
USPSTF Updated Guidelines for Depression Screening in Children and Adolescents
The U.S. Preventive Services Task Force updated the recommendation for screening children and adolescents for Major Depressive Disorder (MDD). View Here
Guidelines for Managing Diabetes in Long Term Care Facilities
The American Diabetes Association emphasizes how to properly manage diabetes in long term care and skilled nursing facilities. View Here
2016 US Adult Immunization Schedule
The Advisory Committee on Immunization Practices makes new recommendations in the 2016 immunization schedule for those aged 19 and older. View Here
WHO Zika Virus Pregnancy Management Guidance
The World Health Organization has provided interim guidance for pregnancy management in light of the Zika virus. View Here
Zika Virus Infection Resource
UpToDate has opened Zika virus information freely to the public and will update as new information is released. View Here
Guillain Barre’ Syndrome Linked to Zika Virus
Zika virus may be linked to Guillain Barre’ Syndrome (GBS); a case-control study suggested that Zika infection with GBS was more likely than a control without GBS. View Here
Guidelines for Breastfeeding with Zika Virus
World Health Organization published breastfeeding guidelines for women with Zika virus who have recently given birth. View Here
Guidelines for Documenting and Controlling Guillain Barre’ in Zika Patients
World Health Organization releases guidelines for the management of Guillain Barre’, and mentions using the Brighton criteria to identify this syndrome in patients. View Here
Updated Interim Guidelines: Caring for Children with Zika Virus Infection
The CDC has updated the guidelines for health care providers caring for infants and children with Zika virus infection, and recommendations evaluating and testing infants with possible infection. View Here
Guidelines for Decreasing Risk of Zika Transmission Through Blood
FDA issued recommendations on preventing Zika virus transmission through donated blood in the United States. View Here
Guidelines for Prevention of Sexual Transmission of Zika Virus
The CDC releases temporary recommendations for preventing the spread of Zika virus through sexual contact for men who live, or have traveled to areas where Zika virus is active. 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:
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.
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.
