Serious bleeding events have been reported in patients taking dabigatran (Pradaxa), according to a new FDA MedWatch alert.
Clinicians can report adverse events through MedWatch or by contacting their local FDA district office consumer complaint coordinator.
Health care professionals and patients are also encouraged to report any adverse events or side effects to the FDA MedWatch.
If retained tissue is discovered, facilities should file a voluntary report with MedWatch, the FDA Safety Information and Adverse Reporting program online.
Any suspected adverse events should be reported to the FDA's MedWatch program.
In its heparin alert, the FDA called on clinicians to watch patients receiving heparin closely and report all adverse events to MedWatch, the FDA's online system.
Any side effects or other product problems with PPIs should be reported via the FDA's MedWatch Adverse Event Reporting program or by calling 800-332-1088.
The FDA warned last week that proton-pump inhibitors (PPIs) may be associated with an increased risk of Clostridium difficile–associated diarrhea (CDAD).
Louis and found an association with gadolinium. As of Dec. 25, 2006, the FDA MedWatch system had received 90 reports of NSF possibly related to gadolinium-containing contrast agents.
Healthcare professionals should remain vigilant for cases of malignancy in patients treated with TNF blockers and report them to the FDA MedWatch program or to the manufacturer.