A multi-center study with 368 hospitalized COVID-19 patients in VA hospitals across US was released today underscoring the serious risks involved for “off-label” use of anti-malarial, Hydroxychloroquine (HCQ) and/or broad-spectrum antibiotic, Azithromycin (AZM) in the treatment for COVID-19 patients. The online release of this study found no evidence of any benefit for using HCQ and AZM, either alone or in combination, to prevent serious illness requiring ventilatory support for COVID-19 patients. More alarmingly, the study also finds that use of HCQ alone was associated with an “increased overall mortality” of COVID-19 patients. Based on these frightening data, the researchers have recommended that until the results of other ongoing prospective, randomized, controlled studies are published showing definite benefits for “off-label” use of HCQ and AZM, these drugs should not be recommended for widespread use in COVID-19 patients. The study may be viewed online at the link: https://www.medrxiv.org/content/10.1101/2020.04.16.20065920v1 (copy also attached below). In view of these latest findings, PBT submitted an urgent appeal today to the Health Ministry and ICMR urging them once again to take immediate steps to prevent widespread use of HCQ and/or AZM in the treatment of COVID-19.
A public interest litigation (PIL) was filed last week by PBT seeking directions that Indian healthcare authority must take necessary precautionary measures against potential serious injury and death due to the adverse effects for “off-label” use of HCQ and AZM in COVID-19 patients and that doctors must obtain “informed consent” by candid disclosure of the potential risks associated with these drugs before using these medicines on COVID-19 patients. Our PIL was based on already published scientific studies that warned about possible serious side-effects including death with the “off-label” use of HCQ and AZM in COVID-19 patients. The US study published today provides further support to our pending PIL which is expected to come before the Hon’ble Apex Court soon.