A combination of antimalarial drugs hydroxychloroquine and antibiotic azithromycin use for the COVID-19 patients has been filed in the Supreme Court claiming that they have lethal side effects.
In order to make necessary changes in the treatment guidelines for seriously ill COVID-19 patients,a plea seeking directions to the government.
The PIL filed by People for Better Treatment (PBT) through its President Dr. Kunal Saha, said the use of HCQ(hydroxychloroquine) and AZM( azithromycin) was recommended for the most serious COVID-19 patients by the Health Ministry based primarily on anecdotal evidence and not as a specific therapy.
The petition has also sought directions to take necessary steps for immediate implementation of all the specific preventive measures recommended in hospitals across India to protect the lives of COVID-19 patients who are being treated with HCQ and AZM.
It said the Ministry of Health & Family Welfare published comprehensive ‘Revised Guidelines on Clinical Management of COVID-19’ on their website on March 31, 2020, that included a detailed description of how to test, diagnose and treat COVID-19 patients.
“Ministry of Health has specifically advised that although no specific anti-viral medicines are available against COVID-19, a combination of HCQ and AZM may be administered as an ‘off-label’ use to the most seriously ill COVID-19 patients who are in ICU,” it said.
As per the plea claim, “Off-label use of HCQ and AZM in acutely ill COVID-19 patients has been highly controversial from the very beginning.
However, both HCQ and AZM were studied extensively prior to FDA approval for their use in indicated medical conditions and both drugs are known for occasional and serious adverse reactions, particularly on the cardiovascular system in humans,” the plea said.
Canadian Medical Association Journal published a very similar warning for using HCQ and AZM to patients with COVID-19 can increase the risks of heart failure and cardiac mortality. Also, an extraordinary joint bulletin issued on April 8 by leading American cardiology societies has cautioned that the use of HCQ and AZM in COVID-19 patients can pose serious dangers due to its inherent adverse effects- the plea added.
“The petitioner-organization submitted an urgent written representation to the Ministry of Health intimating it about the serious and potentially life-threatening dangers for using HCQ and AZM in COVID-19 patients and urging it to immediately adopt the precautionary measures. It has also sought directions to the Union Health Ministry to obtain “informed consent” from all COVID-19 patients for treatment with HCQ and AZM by bringing necessary changes in the treatment guidelines.