FDA’s last word on the safety of hydroxychloroquine and chloroquine was issued last year/ FDA
By Meryl Nass, MD | May 16, 2021
FDA managed to find 385 adverse event reports for either HCQ or CQ in its FDA adverse event reporting system database, as justification for withdrawing its EUA for the chloroquine drugs.
But there wa something strange about these reports. Only 102 of the 385 reports, or 26%, came from the United States. Why would foreigners be submitting reports of adverse events associated with a chloroquine drug to the FDA, instead of to their own pharmacovigilance system?
According to FDA, “FAERS is a database that contains information on adverse event and medication error reports submitted to FDA.” It is not an international database.
Might FDA have requested that foreign entities submit reports? Might some of those foreign entities have been sites where the HCQ overdose trials were conducted? The big three multicenter overdose trials were Recovery, Solidarity and REMAP-Covid. Page 8 of the FDA report does indicate that some of those patients, for whom adverse event reports were filed, had received excessive HCQ doses. Of a total of 256 reports for which FDA had dosing data, depending where you place the excessive dose cut-off, between 23 and 95 had received high doses.
FDA did a number of different things to suppress the use of hydroxychloroquine. This just happens to be one thing I had not previously reported on.
What else is interesting is that this report was compiled in May 2020. It is attached to a website dated July 2020, ten months ago.
In the intervening 10 months, well over 100 papers have been published on HCQ’s use in Covid. FDA claims, “The FDA’s job is to carefully evaluate the scientific data on a drug to be sure that it is both safe and effective for a particular use…” Yet FDA has ignored this massive amount of accumulating literature on hydroxychloroquine, during which 400,000 Americans died of/with Covid. Why? Willful misconduct?
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