FDA Issues Warnings For Serious Side-effects and Death in COVID-19 Patients Treated With Hydroxychloroquine: PBT Writes To ICMR and Health Ministry For Immediate Action

Food & Drug Administration (FDA) in USA issued a stark warning today on the use of anti-malarial drug, Hydroxychloroquine (HCQ), either alone or in combination with Azithromycin (AZM), in the treatment of COVID-19 patients despite president Trump’s vociferous promotion of HCQ (see FDA release below). PBT already lodged a writ petition (PIL) in the Supreme Court against the widespread use of HCQ and AZM in COVID-19 patients without any warning or precautionary measures in place to tackle the serious adverse effects of the drugs. The PIL is expected to be taken up by the Apex Court soon.

Apart from issuing cautions for adverse effects of HCQ in unsuspecting patients, FDA has also categorically held that “Hydroxychloroquine and chloroquine have not been shown to be safe and effective for treating or preventing COVID-19”. The “treatment guidelines” published by ICMR and Health Ministry has unequivocally advised that most seriously ill COVID-19 patients in ICU may be treated with a combination of HCQ and AZM based mostly on anecdotal evidence. PBT already sent several appeals to the health ministry urging them to make necessary changes in the treatment guidelines to keep close monitoring of the patients treated with HCQ and AZM as recommended by the American Heart Association and other major international medical bodies. Unfortunately, Health Ministry remained in complete silence forcing PBT to move the PIL. PBT also submitted a memorandum with Health Ministry and ICMR today to take immediate and appropriate measures based on the FDA warnings today to protect the hapless COVID-19 patients treated with HCQ and/or AZM.

FDA Warnings on COVID-Hydroxychloroquine (April 24, 2020)

H. Times (April 25, 2020)