MedWatch Safety Alerts

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FDA MedWatch Safety Alerts

New information added to the WARNINGS AND PRECAUTIONS section of the drug labeling.
Posted: August 28, 2015, 5:30 pm
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
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
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
Potential adverse events may include eye pain, eye sewelling, ocular discomfort or eye irritation.
Posted: August 25, 2015, 4:00 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.
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
Patients should consider having their mammograms re-evaluated at a certified facility.
Posted: August 17, 2015, 4:00 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.
Posted: August 7, 2015, 8:30 pm
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
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
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
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