(NASDAQ: SRPT), the leader in precision genetic medicine for rare diseases, was informed earlier today that an adverse event report was erroneously submitted to the FDA's adverse event reporting system
(FAERs), a post-marketing surveillance database for approved therapies.
Number of reports (n = 102) with documented dates of administration of expired injectable influenza vaccine--Vaccine Adverse Event Reporting System
, United States, July 2018-January 2019
proprietary clinical trials safety outcomes database, when linked with optimized post-approval spontaneous reporting data from the FDA Adverse Event Reporting System
(FAERS) and Vigibase, claims data and social media provides pharmacovigilance professionals with software, data and analytics to track emerging safety issues through multiple data sets, validate signals seen in spontaneous reporting and engage across these various data sets in dynamic and proactive manner.
Data collection: The data obtained from the nurses were collected using personal information Form included eight items about personal and professional features and "Patient Safety Culture Scale" developed in Turkish by Turkmen et al.11 The Patient Safety Culture Scale includes 51 items and consists of five subscales that include Management and Leadership (17 items), Employee Behavior (14 items), Adverse Event Reporting System
(5 items), Staff Education (7 items), and Care Environment and Technology (8 items).
The FDA panel reviewed disability reports associated with the treatment of uncomplicated urinary tract infections, bronchitis and sinusitis that were sent to the FDA Adverse Event Reporting System
. A disability report was defined as a major disruption in an individual's ability to perform activities of daily living.
As a result, the Vaccine Adverse Event Reporting System
(VAERS), jointly operated by CDC and the U.S.
The reports came from any of five sources: the National Poison Data System, the Food and Drug Administration's adverse event reporting system
, safety reports to manufacturers, and through surveillance of the medical literature, and the news media.
The FDA reviewed 51 cases of chemical leukoderma associated with the Daytrana patch (methylphenidate transdermal system) reported to the FDA Adverse Event Reporting System
(FAERS) database and described in the medical literature from April 2006 to December 2014.
It said : "FDA is developing links between CBER s lot distribution database and FDA s Adverse Event Reporting System
(FAERS) and Vaccine Adverse Event Reporting System
The US Vaccine Adverse Event Reporting System
(VAERS), which relies on volunteer reports, is the sole means of tracking negative effects.
In searching the Vaccine Adverse Event Reporting System
for rotavirus vaccination administration errors between 2006 and 2013, researchers found 66 reports of problems.
Furthermore, the FDA's adverse event reporting system
includes 20 cases of torsades de pointes that were associated with azithromycin.3 Moreover, there have been at least seven reported cases of patients who had normal QT intervals in whom azithromycin caused severe cardiac effects including prolonged QT interval.4 This means that people who experience irregular heartbeat, dyspnoea and fainting while on azithromycin should seek immediate medical care.