FDA MedWatch Safety Alerts
Fluoroquinolone Antibiotics: FDA Requires Labeling Changes Due to Low Blood Sugar Levels and Mental Health Side Effects
FDA is strengthening the current warnings in the prescribing information that fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects.
Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination
The products have been found by the FDA via sample testing and finding to have salmonella contamination. In lieu of such FDA findings the company has implemented standard operating procedures and sterilization processes in accordance to FDA guidelines
Various Aortic Endovascular Graft Systems: Letter to Health Care Providers - UPDATE on Type III Endoleaks
Based on new information, the Endologix AFX with Strata device is at greater risk for a Type III endoleak compared to other endovascular AAA graft systems.
Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections
At least 43 patient reported adverse event after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared in-house samples of Guardian’s product and found that autoclaving and sonication caused the poloxamer 407 to degrade. The amount of poloxamer 407 in Guardian’s product (12%, g/100 mL) is much greater than the maximum amount of poloxamers in FDA-approved ophthalmic products for topical administration (0.1-0.2%, g/100 mL), and the safety profile of drug products intended for intravitreal injection containing poloxamer 407 is unknown.
CARDIOSAVE Hybrid Intra-aortic Balloon Pump by Maquet Datascope Corp.: Class I Recall - Due to Fluid Ingress that May Affect Device Operation and Interrupt or Delay Therapy
Maquet Datascope Corp. is recalling the IABP due to a design issue that allows fluid (such as saline) to seep into the device. The fluid can cause corrosion of internal components such as the electronic circuit boards, and lead to device malfunction (e.g., sudden stops) which can cause a delay or interruption in therapy. Device failure may result in immediate and serious adverse health consequences, including death.
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