New information added to the WARNINGS AND PRECAUTIONS section of the drug labeling.
8/28/2015 5:30:00 PM
Use may result in interruption of insulin delivery that can cause hyperglycemia, which, if left untreated, can result in diabetic ketoacidosis.
8/28/2015 11:40:00 AM
Over or under infusion of fluids to the patient has the potential to cause patient injury or death.
8/27/2015 7:00:00 PM
Failure of syringe module may result in a delay or interruption of therapy and can lead to serious patient injury or death.
8/27/2015 4:00:00 AM
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.
8/26/2015 2:30:00 PM
Potential adverse events may include eye pain, eye sewelling, ocular discomfort or eye irritation.
8/25/2015 4:00:00 AM
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.
8/21/2015 2:00:00 PM
Reports of internal flash fire when the OxyTOTE is mishandled or dropped.
8/18/2015 4:30:00 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.
8/18/2015 2:20:00 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.
8/18/2015 5:00:00 AM
Patients should consider having their mammograms re-evaluated at a certified facility.
8/17/2015 4:00:00 PM
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.
8/7/2015 8:30:00 PM
Increased rate of pump thrombosis, high rate of stroke, bleeding complications.
8/5/2015 3:30:00 PM
Cases of PML in two patients with no prior exposure to immunosuppressant drugs.
8/4/2015 5:15:00 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.
8/4/2015 2:00:00 PM
Missing a dose of Hydrochlorothiazide could result in uncontrolled blood pressure or swelling caused by excess fluid (edema).
8/1/2015 2:00:00 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.
7/31/2015 6:55:00 PM
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.
7/31/2015 4:45:00 PM
FDA warns about prescribing and dispensing errors resulting from brand name confusion with antidepressant Brintellix (vortioxetine) and antiplatelet Brilinta (ticagrelor).
7/30/2015 3:25:00 PM
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.
7/27/2015 7:25:00 PM
Health care professionals should consider limiting GBCA use to clinical circumstances in which the additional information provided by the contrast is necessary.
7/27/2015 2:25:00 PM
If there is contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.
7/25/2015 2:00:00 AM
Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage of blood vessels, which can result in stroke, heart attack or damage to other organs.
7/20/2015 4:00:00 AM
Monitor patients, especially those with risk factors for pulmonary hypertension, for signs of respiratory distress, including tachypnea, flaring nostrils, grunting, and chest wall retractions.
7/16/2015 4:55:00 PM
Calcium Chloride Intravenous Infusion 10% w/v 10mL Prefilled Syringe by Mylan: Market Withdrawal - Difficulties in Administration
7/14/2015 4:00:00 AM