Recall Issued for Bevacizumab
A voluntary recall has been issued for all lots of AmEx Pharmacy's Bevacizumab injectable for inspection of sterility. View Here
Respiratory Disease Associated with E-Cigarette Products
The FDA has issued a safety communication regarding incidents of severe respiratory disease associated with the use of e-cigarette products. Patients have reported symptoms of difficulty breathing, shortness of breath, and chest pain. View Here
Serious Liver Injury Possibly Associated with Hepatitis C Medications
The FDA has issued a warning about a rare occurrence of serious liver injuries associated with the use of Mavyrey, Zepatier, and Vosevi treatment. View Here
Migraine Medication Recalled
Pfizer Inc. has issued a recall on REPLAX (eletriptran hydrobromide) 40 mg tablets for possible microbiologic contamination during manufacturing. View Here
Life-Threatening Symptoms Possible with Online Product
The FDA are notifying consumers to avoid purchasing Miracle Mineral Solution, an unapproved product sold online that may cause life-threatening side effects associated with a chemical reaction caused during mixing instructions. View Here
Parkinson’s Disease Medicine Risk of Prostate Cancer Update
A previous public alert by the FDA in 2010 suggesting that Comtan and Stalevo use could increase the risk of prostate cancer has been updated to report no increase in the risk. View Here
Recall of Infusion Pump
A Class I recall is issued for certain models of Volumat MC Agilia Infusion System and Vigilant Drug Library due to a increased risk of causing excessive infusion of fluids or medications. View Here
Relief Cream and Gel Recalled
Ridge Properties is voluntarily recalling 4% lidocaine topical cream and liquid gel products due to microbiological contamination and ingredient concentrations greater than labeled potency. View Here
Paclitaxel-Coated Balloons and Eluting Stents Associated with Increased Mortality
Analysis from the FDA shows that peripheral arterial disease being treated with paclitaxel-coated devices can potentially increase mortality View Here
Ellipse Implantable Cardioverter Defibrillators Recalled
The FDA has issued a Class I recall for Abbott’s Ellipse Implantable Cardioverter Defibrillators due to partially exposed aluminum wires in the product that may prevent defibrillation function by shorting out. View Here
QIAGEN Filter Tips Recalled
The FDA issued a Class I recall for QIAGEN Filter Tips for use in QIAsymphony SP/AS instruments due to a potential leak that can produce delayed inaccurate results. View Here
Centurion Medical’s Airway Kits Recalled
The FDA issued a Class I recall for Centurion Medical Airway kits containing Sheridan Endotracheal Tubes due to life-threatening issues resulting from tubes disconnecting. View Here
Note: An FDA Class I recall is the most serious type of recall. Use of these devices may cause serious injuries or death.
Drug Monitoring Programs Lead to Decreased Opioid-Related Hospitalizations
Data analyzed from 2011-2016 by states from the Centers of Medicare and Medicaid Services has demonstrated evidence indicating decreased opioid use. Fewer opioid prescriptions and reduced opioid-related hospitalizations have been associated with the states mandating the use of drug monitoring programs. View Here
Recommendations for Flu Vaccine for 2019-2020 Season Released
The American Academy of Pediatrics have published an update in their annual recommendation for both the live-attenuated and the inactivated influenza vaccines for the upcoming flu season for prevention and control in children and adolescents. View Here
Cancer Overtakes Heart Disease as Leading Cause of Death in Wealthy Countries
Cardiovascular disease, which has been the leading cause of death in high-income countries has now been overtaken by cancer. As the rate for heart disease continues to decline, cancer deaths are likely to become the largest "rich-world" killer. View Here
Measles Cases Tripled Within the Year Globally
The World Health Organization reports that a trend across all regions are increasing for measles cases. Experts are calling on social media and communities to do their research to prevent misinformation about vaccines and preventable diseases. View Here
Multiple Sclerosis Treatment Increasing
Within the last decade, the cost of treatment for multiple sclerosis has increased which may lead to barriers in access to medications. View Here
Expansion of Marijuana Research
The U.S. Drug Enforcement Administration (DEA) reports its marijuana research program is finally moving forward after being delayed. With increased marijuana production available for researchers to investigate, new guidelines set by the DEA could result in a wider variety of studies. View Here
Diagnostic Agent: Ga 68 DOTATOC, Pending Approval
The University of Iowa Hospital and Clinics PET Imaging Center is seeking FDA approval of their new drug, Ga 68 DOTATOC, an injectable radioactive diagnostic agent that is used in combination with PET scanning for the localization of somatostatin receptor positive neuroendocrine tumors. View Here
Blood Vessels Impacted by Vaping Without Nicotine
Signs of impaired blood vessels have been seen in healthy young patients with electronic cigarette use, even without nicotine. Evidence demonstrates that vaping can increase signs of inflammation and tissue damage with long term use. View Here
Generic EpiPen Available for Young Children
Following U.S. approval, a generic version of EpiPen for children is now available from Teva Pharmaceutical Industries in retail pharmacies at $300 for a pack of two. View Here
New Drug Improves Lung Cancer Survival
A study has reported that AstraZeneca's Tagarisso demonstrated a significant survival benefit for patients with lung cancer. This medication is now approved in the United States along with 73 other countries. View Here
Common Chemicals Leading to Risk of Diabetes
Researchers have reported that certain substances found in food wrappers, clothing, and furniture could be linked to an increased risk in diabetes; however, the risk may be reduced by adhering to a healthy lifestyle. View Here
Healthy Plant-Based Diet Increases Survival
Studies suggest that a healthy, plant-based diet is one of three good options that are associated with a reduction in heart disease compared to diets consisting mainly meat and refined carbohydrates. View Here
FDA Approves Nourianz as Add-On Therapy for Parkinson’s Disease
Nourianz (istradefylline) was approved by the FDA as an add-on therapy with levodopa/carbidopa in patients who are experiencing “off” episodes in their therapy. View Here
FDA Approves Xenleta for CAP
The FDA approved Xenelat (lefamulin) for the treatment of community acquire pneumonia (CAP) in adults. View Here
FDA Approves Rinvoq for Rheumatoid Arthritis
The FDA approved Rinvoq (upadacitinib)for the treatment of moderate-to-severe rheumatoid arthritis in patients who may experience inadequate response or intolerance to methotrexate. View Here
FDA Approves Inrebic for Rare Bone Marrow Disorder
The FDA approved Inrebic (fedratinib)for the treatment of intermediate-2 or high-risk primary or secondary myelofibrosis. This is the second agent that has been approved by the FDA for the treatment of myelofibrosis. View Here
FDA Approves Rozlytrek
The FDA approved Rozlytrek (entrectinib)for the treatment of NTRK-fusion-positive tumors in pediatric patients 12 years of age or older. Rozlytrek was also approved for the treatment of ROS1-positive, non-small cell lung cancer that has spread to other parts of the body in adults. View Here
FDA Approves Wakix for Narcolepsy in Adult Patients
The FDA approved Wakix (pitolisan)in adult patients who suffer from narcolepsy that is also associated with excessive day time sleepiness. This is the first FDA-approved medication for narcolepsy that is not a scheduled drug. View Here
FDA Approves Combination Therapy with Pretomanid Tablets for Resistant Forms of TB
The FDA approved Pretomanid tablets combined with bedaquiline and linezolid for the treatment of highly resistant pulmonary tuberculosis. View Here
FDA Approves Turalio for Rare Joint Tumor
The FDA approved Turalio (pexidartinib) capsules to treat symptomatic tenosynovial giant cell tumor (TGCT) in patients who are not candidates for surgery. This is the first FDA-approved medication for this disease. View Here
Clinical Guidelines Released for Sudden Hearing Loss
These clinical guidelines were released addressing the presentation, assessment, patient education, treatment, and rehabilitation of suspected sudden sensorineural hearing loss (SSNHL). According to the guidelines, corticosteroids can be offered to patients as initial therapy within 2 weeks of onset. View Here
Clinical Guidelines Released Regarding Testicular Cancer
The European Association of Urology released clinical guidelines for stage 1 seminoma and stage 1 nonseminomatous germ cell tumors. View Here
Statement Issued by the USPSTF on the Prophylaxis of HIV in High Risk Patients
The US Preventative Services Task Force (USPSTF) released a statement recommending that individuals who are at high risk for HIV should initiate preexposure prophylaxis (PrEP) treatment which will require private insurers to cover the cost of PrEP drugs. View Here
New Clinical Guidelines Released for Prescribing Oral Cyclosporine in Dermatology
These guidelines were released by the British Association of Dermatologist for the safe and effective prescribing of cyclosporine in dermatology. View Here
New Clinical Guidelines Released for Trigeminal Neuralgia
Clinical guidelines were released for trigeminal neuralgia, which includes the classification of the disease, indications and contraindications for MRI, and pharmacotherapy for the disease. View Here
Updated Clinical Guidelines Released for Esophageal Cancer
The clinical guidelines were updated regarding the treatment and testing of esophageal cancer. The new update includes biomarker testing, principles of surgery, combined modality therapy, systemic therapy for locally advanced or metastatic disease, and targeted therapies. View Here
Updated Clinical Guidelines Released for Acute Altitude Illness
The Wilderness Medical Society released an updated guideline on the treatment and prevention of acute altitude illness. The update includes the treatment and prevention of acute mountain sickness (AMS), high-altitude cerebral edema (HACE), and high-altitude pulmonary edema (HAPE). View Here
The Louisiana Drug Information Center (DIC) is located on the first floor of the College of Pharmacy in the Bienville Building of the University of Louisiana 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 College of Pharmacy and is not intended for commercial promotion.
