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Treatment of COVID-19 Patients by “Off-label” Hydroxychloroquine and Azithromycin Raises Serious Concerns for Cardiovascular Side-effects: PBT Files Urgent PIL in SC Seeking Safety Changes and “Informed Consent”

Treatment guidelines issued by Ministry of Health and Family Welfare (MOHFQW) have recommended “off-label” use of highly controversial and unproven combination therapy with an anti-malarial drug, Hydroxychloroquine (HCQ) and broad-spectrum antibiotic, Azithromycin (AZM) for seriously ill ICU-bound COVID-19 patients. Serious warnings were issued last week through an urgent joint bulletin by American Heart Association (AHA), American College of Cardiology (ACC) and Heart Rhythm Society (HRS) in USA. Similar warnings for potential irregular heartbeat (arrhythmia), heart failure and possible death were also published last week by Canadian Medical Association Journal (CMAJ). Also, a massive multi-national study with more than 300,ooo patients in USA, UK, Germany, Spain, Netherlands and Japan reported last week of increased “cardiac mortality” in patients receiving MCQ and AZM.

The AHA/ACC/HRS bulletin cautioned doctors using MCQ and AZM on COVID-19 patients to take six specific precautionary therapeutic measures to prevent adverse effects and potential death, especially for patients with pre-existing heart conditions. PBT appealed repeatedly to the Health Ministry to make necessary changes in the treatment guidelines for COVID-19 patients receiving MCQ and AZM and to urgently implement the precautionary measures as advised by the top international cardiac expert bodies (AHA/ACC/HRS/CMAJ) but no action was taken. Compelled to file an urgent PIL in SC today, PBT has sought for immediate implementation of the precautionary measures advised by AHA/ACC/HRS. PBT has also sought that proper “informed consent” must be taken from COVID-19 patients before “off-label” use of MCQ and AZM after explaining all the risks involved as potential adverse effects of these drug combination.

Hindustan Times (Apr. 16, 2020)

Outlook (April 15, 2020) SC PIL COVID

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