STAT (2/23, Silverman) reports that a new analysis published
in Pharmacoepidemiology and Drug Safety concludes that drug-makers “generally
fail to include key data that the FDA might use to assess future warnings” in
their reports to the agency’s Adverse Event Reporting System. According to the
analysis, 40% of expedited reports and 51% of periodic reports filed by
drug-makers to the FDA were incomplete, with 38% lacking the patient’s age and
sex. Another 47% of reports did not include the date of the adverse event.
According to STAT, “reports involving patient deaths offered the least amount
of complete information for all of the key data points.” A spokesperson for the
FDA said the agency is “aware that the quality of adverse event reports may
vary.”
We believe that obtaining legal satisfaction from those who
harmed you shouldn’t require more hardship. That’s why we do everything we can
to streamline the process, and we will file a lawsuit on your behalf if
necessary. If you or a loved one has been affected by prescription drugs due to
a recall or another mistake, and you believe it caused harm, contact Chhabra
& Gibbs today by going to www.cglawms.com or by calling this number:
601-948-8005.
No comments:
Post a Comment