A petition has been filed in the Supreme Court seeking immediate changes in the treatment guidelines for seriously ill COVID-19 patients in ICU and for obtaining “informed consent” from patients who are being treated with Hydroxychloroquine and Azithromycin, claiming it has lethal side effects.
The petition has been filed by an NGO named ‘People for Better Treatment’ through its president Dr. Kunal Saha, who submitted that COVID-19 patients at present are receiving only symptomatic therapy because no specific drug has been invented till now for treating against the new SARS-CoV-2 viruses. Moreover, the Ministry of Health and family welfare has issued “Revised Guidelines on Clinical Management of COVID-19”, that at present no specific antiviral therapy against COVID-19 exists.
However, the present treatment guidelines by Ministry of Health and Family Welfare have recommended to use an old anti-malarial drug, Hydroxychloroquine (HCQ) and a well-known broad-spectrum antibiotic, Azithromycin (AZM) in the most critically ill COVID-19 patients who are in ICU. The off-label use of HCQ and AZM in COVID-19 patients has been said to cause life threatening side effects particularly on the cardiovascular system by healthcare professionals, said Petitioner.
The petitioner has rebutted his submission by stating that “the American Heart Association (AHA), American College of Cardiology (ACC) and Heart Rhythm Society (HRS) in USA issued an extraordinary joint bulletin on 8th April, 2020 with stark warnings for doctors before and during the use of HCQ and AZM in COVID-19, especially for patients with existing cardiac conditions since these drugs have potential to trigger arrhythmia (abnormal heartbeat), heart failure and even death.”
The petitioner has pointed out that though the government has advised “off-label” treatment with HCQ and AZM for serious COVID-19 patients, they have failed to provide the important and specific precautionary measures that doctors should take before and during the use of these drugs.
He further pointed that “although the treatment guidelines have specifically excluded children and pregnant or lactating women, there is no warning to exclude other group of patients with known cardiac ailments, e.g. “congenital long QT syndrome”. There is also no precaution recommended to monitor development of hypokalemia (low serum potassium) or hypomagnesemia (low serum magnesium) in patients receiving HCQ and AZM that may be life-threatening as specifically suggested by AHA/ACC/HRS.”
The Petitioner stated that he had made an urgent written representation to the Ministry of Health and family Welfare about the serious and potentially life-threatening dangers for using HCQ and AZM in COVID-19 patients after the joint bulletin was released by the AHA/ACC/HRS on 8th April, 2020. However, no response was received after which the petitioner had no other option but to approach the Court.
-India Legal Bureau