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发帖数: 21 | 1 http://www.kron4.com/news/national/us-fda-issues-limited-emergency-use-authorization-for-two-drugs-usually-used-to-treat-malaria/?from=timeline&isappinstalled=0
(CNN) — The US Food and Drug Administration (FDA) has issued an emergency
use authorization for chloroquine and hydroxychloroquine to treat patients
hospitalized with COVID-19.
The drugs — which are used to treat malaria and other conditions — have
been called game changers by President Donald Trump.
But thus far, there is little scientific evidence that chloroquine, or its
closely-related analogue hydroxychloroquine, are effective in treating Covid
-19.
What happened? The authorization came in a letter dated Saturday, but the US
Department of Health and Human Services (HHS) acknowledged the FDA’s
action in a Sunday news release. The FDA limited the scope of its
authorization to drugs supplied from the Strategic National Stockpile. The
HHS announced that two pharmaceutical companies — Bayer and a division of
Novartis — had donated the drugs to the stockpile.
Do the drugs work? In its statement, HHS said:
“Anecdotal reports suggest that these drugs may offer some benefit in the
treatment of hospitalized COVID-19 patients.
“The safety profile of these drugs has only been studied for FDA approved
indications, not COVID-19.”
While there’s limited evidence on the efficacy of chloroquine, or
hydroxychloroquine, the FDA said the drugs’ benefits outweighed their risk.
In its letter, the FDA encouraged randomized clinical trials that could
assess the effectiveness of the drugs. It also noted that the known and
potential benefits outweigh the risks.
Who can the drugs be used to treat? The authorization is limited to patients
who are currently hospitalized and weigh at least 50kg, or about 110 pounds
. Under the emergency use authorization, health care providers must contact
their local or state health department to access the drugs. |
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