FDA warns of heart risks with using hydroxychloroquine

FDA warns of heart risks with Trump-promoted malaria drug hydroxychloroquine

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Weeks ago it was considered a wonder drug against COVID-19 but more questions are now being raised on hydroxychloroquine with the latest warning coming from the US Food and Drug Administration.

The US regulatory body asserted there is no evidence to prove the safety and efficacy of hydroxychloroquine and chloroquine against the pandemic virus and their use in such cases was permitted only in emergency conditions.

The FDA ruling on the two anti-malarial that were repurposed as COVID-19 drugs came after several studies and professional bodies of doctors picked holes in the initial euphoria over the two medicines.

“HCQ and chloroquines have not been shown to be safe and effective for treating or preventing COVID-19. They are being studied in clinical trials for COVID-19. We authorise their temporary use during the COVID-19 pandemic for treatment of the virus in hospitalised patients through an Emergency Use Authorisation,” the FDA said in its latest announcement.

 

Last week, a multi-centre US study on 368 COVID-19 patients found no evidence that HCQ alone or in combination with azithromycin (an antibiotic used to treat TB) has any beneficial impacts on pandemic patients. In its conclusion, the study issued a cautionary note on the use of the two drugs until results are available from other trials.

The doctors have also underscored how the two medicines increased the chances of cardiac arrest, necessitating the need to continuously monitor the patients receiving the drugs.

“HCQ and chloroquine can cause abnormal heart rhythms and a dangerously rapid heart rate. Such risks may increase when these medicines are combined with other medicines including the antibiotic Azithromycin. Patients who also have other health issues such as heart and kidney disease are likely to be at increased risk of these heart problems when receiving these medicines,” concurred the FDA.

Similar advice was earlier given by the American Heart Association, American College of Cardiology and Canadian Medical Association.

Incidentally, the Indian Council of Medical Research suggested use of a combination of HCQ and Azithromycin as one of the emergency treatment options for seriously ill COVID-19 patients.

“The treatment guidelines by the Union Health Ministry recommends the potentially toxic combination therapy based solely on anecdotal evidence and without any direct scientific evidence,” said Dr Kunal Saha, a US-based doctor who heads a patient welfare organisation in India.

“In view of the serious warnings issued by the FDA, the ICMR should take imminent steps to alert all doctors and healthcare workers as well as the ordinary citizens about the lack of effectiveness and threat to life associated with the use of HCQ and Azithromycin in COVID-19 patients,” he added.