MedWatch Safety Alerts

MedWatch Safety Alert RSS Feed

FDA MedWatch Safety Alerts

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
Health care professionals should consider limiting GBCA use to clinical circumstances in which the additional information provided by the contrast is necessary.
Posted: July 27, 2015, 2:25 pm
If there is contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.
Posted: July 25, 2015, 2:00 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.
Posted: July 20, 2015, 4:00 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.
Posted: July 16, 2015, 4:55 pm
UPDATED 07/15/2015- Recall classified by FDA as Class I. Health care providers and facilities should immediately stop using the recalled tubes and use alternatives instead.
Posted: July 15, 2015, 4:00 am
Notice to health care providers- please check inventory and crash boxes and remove affected Calcium Chloride Intravenous Infusion subject to market withdrawal.
Posted: July 14, 2015, 8:00 pm
Safety and effectiveness of the Lariat Suture Delivery Device to close the LAA and prevent stroke in patients with atrial fibrillation has not been established.
Posted: July 13, 2015, 4:05 pm
Patients and health care professionals should remain alert for heart-related side effects the entire time that NSAIDs are being taken.
Posted: July 9, 2015, 6:30 pm
Recalled device may not deliver breathing support to the patient. A delay in treatment may potentially lead to patient injury or death.
Posted: July 2, 2015, 3:10 pm
Unapproved products may be contaminated or manufactured incorrectly, which could result in patients receiving the wrong dose, even when administered according to the labeled directions for use.
Posted: July 1, 2015, 2:40 pm
FDA investigating the safety of codeine-containing medicines to treat coughs and colds in children under 18 years because of the potential for slowed or difficult breathing.
Posted: July 1, 2015, 2:00 pm
May cause anesthesia gas to leak and could prevent the ventilator from providing breathing support if not corrected immediately.
Posted: July 1, 2015, 4:00 am
New warning added to drug label to describe risk of chemical leukoderma. chemical leukoderma, have been associated with the use of the Daytrana patch.
Posted: June 24, 2015, 4:10 pm
FDA will update recall with new information as it becomes available.
Posted: June 22, 2015, 4:35 pm
Can cause serious adverse health issues including allergic reactions, pain, infections, or death.
Posted: June 20, 2015, 1:00 am
An interruption in electrical connection would cause the pump to stop, which could cause serious patient injury or death.
Posted: June 16, 2015, 3:55 pm
Health care professionals should continue to follow the recommendations provided in the BOXED WARNING, FDA’s most serious type of warning, and the WARNINGS AND PRECAUTIONS and INDICATIONS AND USAGE sections of the labeling.
Posted: June 16, 2015, 2:00 pm
UPDATED 06/08/2015. Recall Expanded. Administration of a sterile injectable that has foreign particulates has the potential of severe health consequences.
Posted: June 9, 2015, 12:20 am
Incorrect orientation of the patch with the rough side toward the bloodstream may increase the risk of vessel thrombosis and/or embolism. Posted 06/03/2015
Posted: June 3, 2015, 4:00 am