MedWatch Safety Alerts

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FDA MedWatch Safety Alerts

FDA is working to design clinical studies to fully evaluate reduced valve leaflet motion. At this time, FDA believes that bioprosthetic aortic valves remain reasonably safe and effective when used according to their approved indications.
Posted: October 5, 2015, 6:40 pm
Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.
Posted: October 3, 2015, 4:00 am
Acute fracture and emergency revision surgery is a serious adverse health consequence and could lead to neurovascular damage, hematoma, hemorrhage, or death.
Posted: October 2, 2015, 7:25 pm
Clutch mechanism may fail to disengage if proper use, patient considerations, and device selection are not followed in accordance with the manufacturer’s instructions for use.
Posted: September 28, 2015, 6:30 pm
If the sterility of a compounded preparation intended to be sterile is compromised, patients may be at risk.
Posted: September 24, 2015, 1:15 pm
FDA revised the labels to indicate that each vial contains Avycaz 2.5 gram, equivalent to ceftazidime 2 gram and avibactam 0.5 gram.
Posted: September 22, 2015, 2:30 pm
Ultra-rapid metabolizers are more likely to have higher-than-normal amounts of the active form of the opioid in their blood after taking tramadol, which can result in breathing difficulty that may lead to death.
Posted: September 21, 2015, 3:00 pm
If the device stops pumping, the patient will lose consciousness almost immediately, which can lead to serious injury or death.
Posted: September 18, 2015, 3:48 pm
Testing has found that these products contain high levels of lead and/or mercury, which can cause serious health problems.
Posted: September 17, 2015, 11:00 pm
If scope reprocessing procedure is not followed meticulously, the flexible bronchoscope can remain contaminated, potentially resulting in infection transmission from one patient to the next.
Posted: September 17, 2015, 3:00 pm
Certain preventable advisory alarms may result in patients deciding to attempt a System Controller exchange.
Posted: September 16, 2015, 2:00 pm
Enhanced labeling explaining how to monitor patients for neutropenia/manage clozapine treatment. Approval of new, shared REMS.
Posted: September 15, 2015, 6:03 pm
FDA analysis revealing that these dietary supplements contain undeclared drug products making them unapproved drugs.
Posted: September 12, 2015, 12:00 am
FDA added a new Warning and Precaution and revised the Adverse Reactions section of the Invokana and Invokamet drug labels.
Posted: September 10, 2015, 4:45 pm
UPDATED 09/10/2015. Recall classified as Class I. Use may result in interruption of insulin delivery that can cause hyperglycemia, which, if left untreated, can result in diabetic ketoacidosis.
Posted: September 10, 2015, 4:26 pm
Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.
Posted: September 10, 2015, 1:00 pm
An interaction with the rubber stopper in certain lots of these syringes can cause some drugs stored in these syringes to lose potency if filled and not used immediately.
Posted: September 8, 2015, 10:30 pm
UPDATED 09/04/2015. FDA is providing information on specific devices tested by Treanda manufacturer Teva Pharmaceuticals and found compatible with Treanda injection.
Posted: September 4, 2015, 7:00 pm
A patient not receiving enough oxygen can result in possible injury or death.
Posted: September 2, 2015, 2:56 pm
If the ventilator shuts down, a patient may not receive necessary oxygen. This could cause patient injury or death.
Posted: September 2, 2015, 2:20 pm