The Food and Drug Administration (FDA) has withdrawn its emergency authorization of antimalarial drugs hydroxychloroquine and chloroquine for coronavirus treatment. Among these two, Hydroxychloroquine was in headlines for President Trump endorsing its usage, saying he uses it too.
FDA has been earlier reviewing all the research evidence on these drugs mainly on their mechanism of action. After going through plenty of studies, FDA now declares that these two drugs surely don’t pass the standard criteria. Hence they are not a top choice of coronavirus treatment.
This information is available on the FDA’s official website under the latest release from the federal agency.
Despite the earlier authorization, FDA now believes that these two antimalarial drugs are ineffective for coronavirus patients. In addition to this, it is also reasonable that they might cause side effects in users.
Denise Hinton from FDA wrote a letter to the Gary Disbrow from “Biomedical Advanced Research and Development Authority (BARDA)”. It says that there is a reasonable doubt that the side effects of these two out ways their medical benefits.
This letter uses abbreviations “HCQ” and “CQ” for describing hydroxychloroquine and chloroquine, calling to revoke their usage to treat coronavirus. Going into detail, the formulation of these two medicines is now “un-authorized” by FDA for coronavirus patients.
It doesn’t mean that doctors cannot give this medicine to their patients. They can still give these off-label drugs to their coronavirus patients along with other medicines.
Hydroxychloroquine is also an effective medicine for treating lupus and malaria. But its benefits for coronavirus patients were all over social media after President Trump announcing its efficacy. As per Trump, he is using it as per his ‘doctor’s guidance’.
In some of the cases, these medicines did some help in treating coronavirus. But these benefits were not consistent. Only some patients experienced ‘some’ benefits from them.
This revocation of emergency authorization of hydroxychloroquine came forward after the Biomedical Advanced Research and Development Authority requested for it. This body works under the Department of Health and Human Services.
This revocation is as per new data suggested by the clinical trials which tell that it might be ineffective in treating coronavirus patients.
Earlier in April, FDA warned about the usage of hydroxychloroquine or chloroquine on coronavirus patients without medical supervision. It means using these medicines outside a hospital or clinic without a doctor prescribing it. As to it, it can cause more dangers than benefits to the users.
Dr. Anand Shah, the deputy commissioner for Medical and Scientific Affairs in the FDA writes that all actions by FDA are under scientific evidence. The decisions that it takes especially on medicines for coronavirus treatment is under the latest clinical data and researches. And all this effort is to improve the treatment quality of coronavirus in the USA.
He also wrote that the FDA always relies on trusted and quality research-based evidence while reviewing any product. It will still continue its investigation on all the emergency authorization treatments for coronavirus and change its stance as per changes in data.