MedWatch Safety Alert RSS Feed
FDA MedWatch Safety Alerts
New information added to the WARNINGS AND PRECAUTIONS section of the drug labeling.
Posted: August 28, 2015, 5:30 pm
OmniPod (Pod) Insulin Management System by Insulet Corporation: Recall - Possibility of a Higher Rate of Failure
Use may result in interruption of insulin delivery that can cause hyperglycemia, which, if left untreated, can result in diabetic ketoacidosis.
Posted: August 28, 2015, 11:40 am
Alaris Medley Large Volume Pump (LVP) Frame Membrane by Elite Biomedical Solutions: Class I Recall - Frame Membrane May Allow Over or Under Delivery of Fluid by an Infusion Pump
Over or under infusion of fluids to the patient has the potential to cause patient injury or death.
Posted: August 27, 2015, 7:00 pm
Failure of syringe module may result in a delay or interruption of therapy and can lead to serious patient injury or death.
Posted: August 27, 2015, 4:00 am
Hudson RCI Sheridan Sher-I-Bronch Endobroncial Tube by Teleflex Medical: Class I Recall - Connector May Crack or Separate
The connector may break or separate on the tube. If this happens, the device may leak, causing the patient to not receive enough oxygen (hypoxia) or experience respiratory distress.
Posted: August 26, 2015, 2:30 pm
Refresh Lacri-Lube, Refresh P.M., FML 0.1 Percent and Blephamide 10 Percent/0.2 Percent by Allergan: Recall - Particulate Matter
Potential adverse events may include eye pain, eye sewelling, ocular discomfort or eye irritation.
Posted: August 25, 2015, 4:00 am
Picato (ingenol mebutate) Gel: Drug Safety Communication - FDA Warns of Severe Adverse Events, Requires Label Changes
Severe allergic reactions, skin rashes, & cases of shingles (herpes zoster reactivation) reported. Severe eye injuries and skin reactions have occurred when Picato gel is not applied according to recommendations in the label.
Posted: August 21, 2015, 2:00 pm
Reports of internal flash fire when the OxyTOTE is mishandled or dropped.
Posted: August 18, 2015, 3:30 pm
Parenteral administration of non-sterile injection products may result in a site-specific or systemic infection, which in turn may cause hospitalization, significant morbidity, or a fatal outcome.
Posted: August 18, 2015, 1:20 pm
Preliminary information indicates that drugs stored in these syringes may lose potency over a period of time due to a possible interaction with the rubber stopper in the syringe.
Posted: August 18, 2015, 4:00 am
Mammograms at Boston Diagnostic Imaging in Orlanda, Florida: FDA Safety Communication - Quality Problems
Patients should consider having their mammograms re-evaluated at a certified facility.
Posted: August 17, 2015, 4:00 pm
Beacon Tip Angiographic Catheters by Cook Medical: Class 1 Recall - Catheter Tip May Slip or Separate
If this occurs, the tip could enter the patient’s bloodstream. This could cause serious injury to the patient and require additional medical intervention to retrieve the tip, or cause death.
Posted: August 7, 2015, 8:30 pm
Implantable Left Ventricular Assist Devices (LVADs): FDA Safety Communication - Serious Adverse Events
Increased rate of pump thrombosis, high rate of stroke, bleeding complications.
Posted: August 5, 2015, 3:30 pm
Cases of PML in two patients with no prior exposure to immunosuppressant drugs.
Posted: August 4, 2015, 5:15 pm
Hospitals and health care facilities can, in addition to meticulously following manufacturer reprocessing instructions, take additional steps to further reduce the risk of infection.
Posted: August 4, 2015, 2:00 pm
Hydrochlorothiazide Tablets by Unichem Pharmaceuticals (USA), Inc: Recall - Potential Presence of Foreign Tablets Contamination
Missing a dose of Hydrochlorothiazide could result in uncontrolled blood pressure or swelling caused by excess fluid (edema).
Posted: August 1, 2015, 2:00 am
The device could be accessed remotely through a hospital’s network. This could allow an unauthorized user to control the device and change the dosage the pump delivers, which could lead to over- or under-infusion of critical patient therapies.
Posted: July 31, 2015, 6:55 pm
0.9 Percent Sodium Chloride Injection, USP (AUTO-C) by Baxter International: Recall - Potential For Leaking Containers, Particulate Matter and Missing Port
Leaking containers, particulate matter and missing port protectors could result in contamination of the solution. If not detected, this could lead to a bloodstream infection or other serious adverse health consequences.
Posted: July 31, 2015, 4:45 pm
FDA warns about prescribing and dispensing errors resulting from brand name confusion with antidepressant Brintellix (vortioxetine) and antiplatelet Brilinta (ticagrelor).
Posted: July 30, 2015, 3:25 pm
Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) by Teva Parenteral Medicines: Recall - Particulate Matter
Administration of an intravenous product with particulate matter has the potential to result in inflammation, allergic reactions, or blockage of blood vessels, leading to tissue death, which may be life-threatening if vital organs are affected.
Posted: July 27, 2015, 7:25 pm