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Wednesday, January 11, 2017

FAERS Reports on Counterfeit Medications

AARP magazine is using some FAERS data that I provided as part of a forthcoming article on adverse events and counterfeit medications.

They were interested in FAERS reports in which counterfeit was part of the MedDRA preferred term. This included:

  • suspected counterfeit product
  • product counterfeit
  • counterfeit drug administered

A common co-reported adverse reaction was drug ineffective (not surprising).

The patient outcomes in this group of cases is disturbing, with 703 cases reporting death.

In contrast to the overall FAERS database, the reports concerning counterfeit drugs are dominated by males.

There is also a spike in the # of reports of counterfeit products in 2015. Keep in mind that the FDA has not yet released data for the 4th quarter of 2016, but it seems unlikely that one additional quarter's worth of data will push 2016 above the 2015 number.

Here's the distribution of "occurring countries." More than I expected in China since this database is focused on the USA.