People taking one of the drugs listed who experience an adverse event should be encouraged to inform their health care providers, who in turn should be encouraged to report the event to the AERS
, which "will help us in evaluating that potential association," Dr.
Solutions such as these enable rigorous statistical analysis and data mining of pre-marketing clinical studies and post-marketing safety databases such as AERS
data has clearly played a prominent role in the story of Baycol's demise and in the ensuing litigation about the drug.
Initially the Clinical Services division will offer pharmacovigilance monitoring supported by Oracle AERS
software, bioanalytical studies utilizing API 4000 LC/MS systems, and medical writing services.
Katz said that the agency is continuing to review the AERS
database and that it also will review requested data from the makers of Myobloc (Solstice Neu-rosciences Inc.
Since February, the FDA's Office of Drug Safety has searched the AERS
database for reports of congenital eye disorders in association with citalopram, escitalopram, and other antidepressants.
The Qscan product is an excellent resource for clean FDA AERS
data," states Matthew Reynolds, Ph.
Between January 1998, soon after the FDA issued the warning letter, and July 2009, 12 maternal cases of serious cardiovascular events were reported to AERS
, including cardiac arrhythmias, MI, pulmonary edema, hypertension, and tachycardia, associated with the use of terbutaline.
A total of 115 neuropsychiatric events in patients using zanamivir to treat influenza have been reported to AERS
between July 1999, when the drug was approved, and Aug.
The information was derived from AERS
using the following search criteria: congenital, familial, and genetic disorders; pregnancy, puerperium and perinatal conditions; and cognitive and attention disorders and disturbances.
A search of the 2001 AERS
reports identified 57 cases of possible neonatal withdrawal syndrome that met the FDA's case definition: maternal SRI use up to the time of delivery; symptoms that could not be attributed to another cause, with an onset hours to days after delivery, which resolved in days or weeks; or a case that was reported specifically as SRI withdrawal.