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The FDA Warns that Biotin May Interfere with Lab Tests: FDA Safety Communication
Wednesday, November 29, 2017
The FDA is alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly interfere with certain lab tests and cause incorrect test results which may go undetected.
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FDA Alerts Consumers About Potentially Life-Threatening Health Problems Linked to Limbrel
Monday, November 27, 2017
The U.S. Food and Drug Administration is investigating serious adverse events involving Limbrel, a product in capsule form currently being marketed as a medical food to manage the metabolic processes associated with osteoarthritis.
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FDA Statement: Impact of IV Fluid Shortages Following Hurricane Destruction
Monday, November 20, 2017
Update on the efforts by the FDA to address IV fluid shortages exacerbated by Hurricane Maria and advice for hospitals in managing the shortage
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Baxter Issues A Voluntary Nationwide Recall For One Lot of Nexterone Injection Due To Presence Of Particulate Matter
Thursday, November 16, 2017
Baxter International Inc. announced today it is voluntarily recalling one lot of NEXTERONE (amiodarone HCl) 150 mg/100 mL Premixed Injection – distributed between 8/23/2017 and 10/2/2017 in the United States to wholesalers/distributors and healthcare facilities – due to the potential presence of...
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Advice for Providers Treating Patients in or Recently Returned from Hurricane-Affected Areas
Wednesday, October 25, 2017
The purpose of this HAN advisory is to remind clinicians assessing patients currently in or recently returned from hurricane-affected areas to be vigilant in looking for certain infectious diseases, including leptospirosis, dengue, hepatitis A, typhoid fever, vibriosis, and influenza. Additionally,...
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St. Jude Medical Recalls Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators
Friday, October 20, 2017
St. Jude Medical Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are devices that provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms.
ICDs and CRT-Ds are both implanted under the...
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Class 2 Device Recall Baxter Amia Automated Peritoneal Dialysis Set with Cassette
Friday, September 22, 2017
The firm (Baxter) initiated the recall by letter on 09/05/2017. The patients and clinics were directed to locate and remove all affected product and to contact Baxter Healthcare Center for Service to arrange for return and credit. The Baxter Healthcare Center for Service can be reached at...
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Ocaliva (obeticholic acid): Drug Safety Communication - Increased Risk of Serious Liver Injury
Friday, September 22, 2017
FDA is warning that the liver disease medicine Ocaliva (obeticholic acid) is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death. These patients are receiving excessive dosing, particularly a...
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Guidance to All Providers Regarding Provision of Services During Hurricane Irma
Monday, September 18, 2017
Guidance to All Providers Regarding Provision of Services During Hurricane Irma. This Guidance Applies for Both Fee-For-Service and Managed Care Providers.
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Rifampin/Penicillin-Resistant Strain of RB51 Brucella Contracted from Consumption of Raw Milk
Wednesday, September 13, 2017
The Texas Department of State Health Services, with assistance from CDC, is investigating Brucella RB51 exposures and illnesses that may be connected to the purchase and consumption of raw (unpasteurized) milk from K-Bar Dairy in Paradise, Texas. Symptoms of brucellosis can include: fever, sweats,...
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