New Delhi: The United States Food and Drug Administration (US FDA) has warned Americans against self-prescription of the drug hydroxychloroquine, “either alone or combined with azithromycin”, outside hospital settings.
In March, US President Donald Trump had touted the drug as a “game changer” in the fight against novel coronavirus. “I sure as hell think we ought to give it a try,” he had said.
But the FDA has warned the public not to buy this drug from online pharmacies without a prescription.
“Serious poisoning and death have been reported after mistaken use of a chloroquine product not intended to be taken by humans. If you have these medicines in your home, keep them in childproof containers out of the reach of children to prevent accidental poisoning,” it stated in its ‘drug safety communication’ Friday.
The FDA added “be aware that there are no proven treatments for Covid-19 and no vaccine”.
Highlighting the concern of side-effects of HCQ on people suffering from cardiovascular diseases, FDA said: “To decrease the risk of these heart problems that can be life-threatening, we are warning the public that hydroxychloroquine and chloroquine, either alone or combined with azithromycin, when used for Covid-19, should be limited to clinical trial settings or for treating certain hospitalised patients.
“If you are receiving hydroxychloroquine or chloroquine for Covid-19 and experience irregular heartbeats, dizziness, or fainting, seek medical attention right away… Hydroxychloroquine and chloroquine have not been shown to be safe and effective for treating or preventing Covid-19,” it warned.
The reason for these concerns
Anti-malaria drug chloroquine and its derivative HCQ can cause abnormal heart rhythms, such as a dangerously rapid heart rate called ventricular tachycardia.
“These risks may increase when these medicines are combined with other medicines known to prolong the QT interval, including the antibiotic azithromycin, which is also being used in some Covid-19 patients without FDA approval for this condition,” the FDA said.
Patients who also have other health issues such as heart and kidney disease are likely to be at increased risk of heart problems when receiving these medicines, it said.
However, the FDA did suggest to those taking the drug according to medical advice not to stop without consulting professionals.
“Patients taking hydroxychloroquine or chloroquine for FDA-approved indications to treat malaria or autoimmune conditions should continue taking their medicine as prescribed. The benefits of these medicines outweigh the risks at the recommended doses for these conditions,” it said.
The FDA has recommended “initial evaluation and monitoring” before prescribing or using hydroxychloroquine or chloroquine even under emergency use or in clinical trials. It has suggested monitoring baseline electrocardiogram (ECG), electrolytes, kidney function and liver tests.
What India has done
India, which has recommended HCQ as a preventive drug for high-risk individuals like front-line health workers as well as Covid-19 patients’ family members, has also taken steps to tighten the regulations for its sale and warn the public about consequences of self-medication.
HCQ has been moved from Schedule H to Schedule H1, under which, the drug is dispensed only on prescription, and it is mandatory for the chemist to maintain a record of prescriptions for at least three months.