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Class I Recall - Halo One Thin-Walled Guiding Sheath
Bard Peripheral Vascular Inc. is recalling the Halo One Thin-Walled Guiding Sheath because the body could separate from the hub while removing the device from the patient’s leg. View Here
FDA Warning - Homeopathic Teething Products
The FDA has found inconsistent amounts of belladonna in certain homeopathic teething products, sometimes far exceeding the amount claimed on the label. View Here
Recall of NucliSENS Reagents and Accessory Products
This is a continuation of a previous recall of bioMerieux’s NucliSENS easyMAG Magnetic Silica and the accessory products due to a quality problem with one of the components. View Here
Voluntary Recall of Vancomycin Hydrochloride for Injection
Hospira, Inc. is voluntarily recalling one lot of Vancomycin Hydrochloride for Injection due to a customer report for the presence of particulate matter within a single vial. View Here
FDA Safety Communication Update - Pentax Duodenoscope
The FDA is providing an update to their Safety Communication from February 2016 about a design issue with the Pentax ED-3490TK duodenoscope that could increase the risk for a patient to get an infection. View Here
Voluntary Field Action for LIFEPAK 1000 Defibrillator
Physio-Control has announced that they are launching a voluntary field action for the LIFEPAK 1000 defibrillator due to reported instances of the device unexpectedly shutting off during patient treatment. View Here
Safety Communication - Duodenoscopes by Fujifilm Medical Systems
Fuji has informed the FDA that they plan to remove legacy 250/450 duodenoscope models from clinical use due to the limited number that is currently in use. View Here
FDA Warning - Do Not Use PNC-27
The FDA has issued a warning not to purchase or use PNC-27, a product used for the treatment or cure for cancer, due to discovering Variovorax paradoxus in a sample. View Here
FDA Safety Communication - Important Safety Precautions
The FDA has received reports of serious adverse events related to the use of implantable infusion pumps in the MR environment. View Here
Recall of Source Administration Sets
Bayer has determined that all Source Administration Sets used with the Medrad Intego PET Infusion System may produce particulate matter in the medicine vials. View Here
FDA Safety Communication - Potential Cybersecurity Vulnerabilities in St. Jude Medical Products
The FDA is providing information regarding St. Jude Medical’s radio frequency (RF)-enabled implantable cardiac devices and Merlin@home Transmitter due to potential harm to the patient because of cybersecurity vulnerabilities that if exploited, can allow someone other than the patient’s physician to remotely access the device by altering the transmitter. View Here
Laboratory Corporation of America (LabCorp): False Positives
LabCorp has seen an unexpected number of false positives since transitioning to the ZIKV Detect test with the CDC confirming less than half of the positive results reported. View Here
Class I Recall on Standard Offset Cup Impactor
Greatbatch Medical is recalling their Standard Offset Cup Impactor with POM-C handle due to a failing sterility testing when sterilized in a dedicated instrument case. Surgical devices that are not sterile can lead to detrimental to the patient. View Here
Chantix & Zyban - Mental Health Side Effects Warnings Revised
Based on FDA review of a large clinical trial, the Boxed Warnings for serious mental health effects from Chantix and Zyban will be removed due to the risks on mood, behavior, and thinking being lower than once suspected. View Here
General Anesthetic & Sedation Drugs: New Warnings for Young Children and Pregnant Women
The FDA has required a new warning stating that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than 3 years or in pregnant women during their third trimester may affect the development of children’s brains. View Here
Label Updates for Pioglitazone-Containing Medications Regarding Possible Bladder Cancer Link
After performing an updated review, the FDA has approved label updates for the type-2 diabetes medication, pioglitazone (Actos), describing additional studies that have concluded that the drug may be linked to an increased risk of bladder cancer. View Here
Class I Recall - Convenience Kits With Multi-Med Single Lumen Catheters
Centurion is recalling their Centurion Convenience Kits containing Multi-Med Single Lumen Catheters due to the potential for excess material to remain at the tip of the catheter during the manufacturing process. View Here
President Calls for Lower Drug Prices & More U.S. Production
President Trump is calling on the pharmaceutical industry to increase U.S. production and lower prices, while also vowing to speed up approval times for new medicines and appoint a new U.S. Food and Drug Administration leader soon. View Here
Physical Activity May Protect Against Childhood Depression
A new study by researchers at the Norwegian University of Science and Technology demonstrated that physical activity, getting sweaty, and rough housing has correlated with a lower risk of developing depression along with physical benefits. View Here
Antibiotics Stimulate Growth of Bacteria
Scientists at the University of Exeter have discovered that antibiotics can stimulate the growth of bacteria after running multiple rounds of tests on E. coli. View Here
Mylan Under Investigation for Epipen Practices
U.S. antitrust authorities launched an investigation on Mylan for its EpiPen emergency allergy treatment which has increased in price from $100 in 2008 to $600 and was listed with Medicaid as a generic despite it being listed by FDA as a branded product. View Here
Margetuximab Shows Promise in Phase 1 Trial
In patients with breast cancer with human epidermal growth factor receptor 2 (HER2)-positive advanced solid tumors, margetuximab was shown to be well tolerated and reduce tumors in more than half of those who responded to the medication. View Here
Scientists May Have Found a Way to Combat Antibiotic Resistance
Scientists from Oregon State University have found a molecule that they believe can combat an enzyme produced by bacteria that is responsible for coding resistance. View Here
Prototype Presented to Allow 3-D Printing of Human Skin
The prototype presented from scientists from the Universidad Carlos III de Madrid allows 3D-bioprinting of fully functional human skin that can be used in transplants or for research and testing of cosmetic, chemical, and pharmaceutical products. View Here
Heart Stent Patients Demonstrate Improved Adherence Using App
A small randomized trial has found that an app called “MyIDEA” developed by researchers at the University of Illinois at Chicago has helped heart patients with drug-eluting stents to take their medications correctly. View Here
Most Drug-Resistant Tuberculosis Cases Caused by Person-to-Person Contact
A study in South Africa has shown that the worst form of drug-resistant tuberculosis is mostly being spread from person-to-person contact. View Here
Walking 20 Minutes Daily May Reduce Body Inflammation
A new study suggests that walking 20 minutes daily may fight inflammation through releasing epinephrine and norepinephrine which acts on immune cells to decrease TNF release and the inflammatory response. View Here
Drug Combination Potentially Safe and Effective Alternative for Type 2 Diabetes
A combination of pioglitazone and exenatide may be a safe and effective alternative to insulin in patients with type 2 diabetes that are poorly controlled while taking metformin and a sulfonylurea. View Here
Marijuana’s Health Effects
A federal advisory panel reported different health effects that marijuana can cause ranging from easing chronic pain to developing schizophrenia. View Here
High Deductibles Impact Chronic Diseases
A study involving diabetics suggests that out-of-pocket costs from high deductibles may discourage poor adults with chronic conditions from seeking needed medical care and increase emergency department visits for preventable disease complications. View Here
The Facts about Vaccines
This CNN article discusses recommended vaccine schedules, addresses myths regarding vaccines causing autism, and explains why it is important to receive vaccines. View Here
Plan Ahead to use Folic Acid to Prevent Birth Defects
Consuming the recommended amount of folic acid (400 mcg/day), a B vitamin, before conception can prevent serious birth defects such as anencephaly and spina bifida. View Here
“Bionic Pancreas” Shown to be Safe and Effective
A randomized crossover study with type-1 diabetics showed that the bihormonal bionic pancreas produced a significantly lower mean glucose concentration than a conventional or sensor-augmented insulin pump. View Here
Amyloid Drug Fails Major Trial
Eli Lilly has announced that the anti-amyloid drug, solanezumab, failed to meet its primary endpoint in the EXPEDITION3 trial. View Here
FDA Approves Drug for Chronic Idiopathic Constipation
The FDA has approved Trulance (plecanatide) for use in adults who have chronic idiopathic constipation. Trulance works in the upper GI tract to stimulate the secretion of intestinal fluid and support regular bowel function. View Here
First Drug for Spinal Muscle Atrophy has been FDA Approved
The FDA has approved Spinraza (nusinersen) as the first drug to treat the genetic disease of spinal muscle atrophy in children and adults. Spinraza is an injection to be administered into the fluid surrounding the spinal cord. View Here
Rubraca Granted Accelerated Approval by FDA for Advanced Ovarian Cancer
Rubraca (rucaparib) has been approved for women who have been treated with two or more chemotherapies and whose advanced ovarian cancer has a specific gene mutation (deleterious BRCA) confirmed through an FDA-approved companion diagnostic test. View Here
Eucrisa Approved by FDA for Eczema
The FDA approved Eucrisa (crisaborole),a phosphodiesterase 4 (PDE-4) inhibitor, ointment to be applied topically twice daily for treatment of mild to moderate atopic dermatitis in patients two years of age and older. View Here
FDA Approves New Indication for Jardiance
Jardiance (empagliflozin) has a new indication of reducing the risk of cardiovascular death in adults with both type-2 diabetes and cardiovascular disease based on the results of a postmarket clinical trial. View Here
New Combination Drug Approved for Type 2 Diabetes
Xultophy (insulin degludec and liraglutide) has been approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (< 50 units daily) or liraglutide (≤ 1.8 mg daily). View Here
Soliqua 100/33 Approved to Help Type 2 Diabetic Patients Improve Glycemic Control
The FDA has approved Soliqua (insuline glargine and lixisenatide) 100/33 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not controlled on insuline glargine (< 60 units daily) or lixisenatide. View Here
Introsa Approved for Intercourse Pain in Postmenopausal Women
Introsa (prasterone), also known as dehydroepiandrosterone (DHEA), has been FDA approved for the treatment of moderate to severe pain during sexual intercourse (dyspareunia), which is a symptom of vulvar and vaginal atrophy due to menopause. View Here
Vemlidy Approved for Chronic Hepatitis B
The FDA has approved Vemlidy (tenofovir alafenamide) for the treatment of chronic hepatitis B infection in adults who also have compensated liver disease. View Here
Zinplava Approved for Clostridium difficile Infection
The FDA has approved the Zinplava (bezlotoxumab) injection for patients with Clostridium difficile infection (CDI) who are 18 years of age or older and are already receiving antibacterial drug treatment for CDI and are at high risk for CDI recurrence. View Here
Lartruvo with Doxorubicin Approved for Advanced Soft Tissue Sarcoma
The FDA has granted accelerated approval to Lartruvo (olaratumab) with doxorubicin to treat adults with certain types of soft tissue sarcoma. View Here
Updated Hypertension Guidelines Released
The American College of Physicians (ACP) and the American Academy of Family Physicians (AAFP) have released a joint practice guideline on systolic blood pressure targets for people ≥ 60 years of age with hypertension and the risks of lower targets. View Here
Atrial Fibrillation Treatment Interruption Guidelines
The American College of Cardiology released revised recommendations to help clinicians determine if, and for how long atrial fibrillation patients on anticoagulants should be taken off the medications before scheduled surgeries. View Here
The American College of Physicians (ACP) Guidelines Endorse Treatments for Type 2 Diabetes
The ACP guidelines have been updated to recommend first and second line therapies in patients with type 2 diabetes. View Here
New Guidelines for Gout Treatment
The American College of Physicians (ACP) developed guidelines to provide clinical recommendations on how to manage acute and recurrent gout. View Here
New American Diabetes Association (ADA) Guideline on Diabetic Neuropathy
The ADA has released a new guideline advising on clinical management of diabetic neuropathy. View Here
New American Heart Association (AHA) Recommendations for Telemedicine
The AHA has released new recommendations for telemedicine in cardiovascular disease (CVD) and stroke care. View Here
New Guidelines for Heart Risk and Calcium Supplements
Evidence has shown that calcium supplements, with or without vitamin D, are not associated with heart disease or stroke at doses up to 2500 mg/day. View Here
New Guidelines for HIV Self-Testing and Partner Notification
The World Health Organization (WHO) now recommends widespread use of HIV self-testing to increase the number of patients with HIV to know their status. View Here
New Guidelines on Psoriasis Treatment
A panel of experts have defined treatment targets designed to help evaluate treatment responses in patients with psoriasis. View Here
Polio Vaccine - New Recommendations
The World Health Organization released a position paper in March 2016 to replace the 2014 WHO position paper that stresses an essential switch from the trivalent version (tOPV) (containing type 1, 2 and 3 serotypes) to the bivalent version (bOPV) (containing only type 1 and 3 serotypes) in national immunization programs and globally due to immunity gaps. View Here
USPSTF Issues New Recommendations for Statins
The US Preventive Services Task Force (USPSTF) has issued new recommendations for using statins for primary prevention of cardiovascular disease in adults. View Here
Gentamicin Dosing Guidelines Revised for Neonatal Sepsis
The dosing guidelines for gentamicin have been revised in order to optimize neonatal sepsis treatment. View Abstract Here
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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.
