The agency opines that the blind should be broken for serious and
unexpected adverse events that would meet the reporting criteria, either as single or multiple occurrences, because knowledge of treatment assignment may be essential for medical management of the subject, and may provide safety information having implications for the conduct of the trial.
To monitor the occurrence of adverse events associated with vaccination, both those expected on the basis of previous experience and possible new
unexpected adverse events, CDC and state health departments have established the Smallpox Vaccine Adverse Events Monitoring and Response System.
Cases of rare and
unexpected adverse events, including three fatal cases of unpredictable, fulminant hepatitis, have been reported.
Moreover, LCS-16 was generally well tolerated, with no
unexpected adverse events reported.
The preliminary data for the evaluation study was conducted on 249 patients by converting them from Suboxone to BEMA Buprenorphine/Naloxone, which indicated favourable oral tolerability without any signs of
unexpected adverse events.
Serious or
unexpected adverse events associated with metoclopramide can be reported to MedWatch at 800-332-1088 or www.
Serious or
unexpected adverse events associated with bisphosphonates can he reported to the FDA's MedWatch program at 800-332-1088 or www.
Serious or
unexpected adverse events associated with surgical mesh or other devices can be reported to MedWatch by phone at 800-332 1088 or online at www.
HansJorg Mobius, of Merz Pharmaceuticals, "comedication" of memantine with cholinesterase inhibitors was safe and well tolerated, without
unexpected adverse events and no drug discontinuations.
Serious or
unexpected adverse events associated with these medications can be reported to MedWatch at www.
Serious or
unexpected adverse events associated with drugs can be reported to the FDA Med Watch program at 800-332-1088 or www.
Consumers who experience any
unexpected adverse events should also consult a health care professional as soon as possible.
