FDA Gives Emergency Authorization of Hydroxychloroquine Use

The Food And Drug Administration (FDA) issued an emergency authorization Sunday for hydroxychloroquine, a drug already used to treat malaria and other ailments, which has shown anecdotal efficacy against coronavirus.

The use of the drug — often paired with azithromycin — has not yet been proven in clinical trials to be effective against the disease. However, given reported success in a growing number of small, non-randomized studies; as well as testimonials from doctors and patients about the use of the “off-label” drug regimen, doctors are said to be prescribing the treatment to patients who are severely ill. Anecdotally, many doctors are taking it prophylactically.

The Department of Health and Human Services (HHS) issued a statement on Sunday:

The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to BARDA to allow hydroxychloroquine sulfate and chloroquine phosphate products donated to the Strategic National Stockpile (SNS) to be distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible.

Mike Rogers Accused of ‘Cowardly Compromise’ After Stunning Abortion Flip-Flop

Breaking: Judge Dismisses Charges Against FBI Agents Accused of Lying About Hunter Biden Laptop

Woman, 20, identified as co-pilot of plane that crashed in Florida

Judge dismisses criminal complaint against two ex-FBI officials accused of lying to Congress about Hunter Biden

Union boss stuns with major Republican endorsement as election nears

Talarico campaigns alongside Democrat who called ICE ‘new KKK’ and demanded its abolition

Democratic Senator Chris Murphy Hospitalized After Suffering Stroke

Martha Stewart Makes Homeless Costume 10x Worse With One of the Most Disastrous Apologies We’ve Ever Heard

Haley Stevens’ endorsement stunt backfires with El-Sayed setting single-day fundraising record

Watch: Giant Man Picks Up Kicking, Screaming Woman and Simply Carries Her Away in Daylight Kidnapping Attempt

Steve Hilton rallies at ‘symbol of 16 years of Democrat failure’ in closing days of California race

Watch: El-Sayed’s Last Minute ’60 Minutes’ Mess – Just Can’t Say Israel Has Right to Exist Full Stop

Staff exodus ensues after Dem Haley Stevens flips on own party and endorses GOP rival and more top headlines

George Floyd-era police watchdog chair charged with selling name to inmate who vowed to ‘blow down’ witness

The GOP reveals a fresh $100B talking point as the battle for Congress looms

HHS also noted that it had “accepted 30 million doses of hydroxychloroquine sulfate donated by Sandoz, the Novartis generics and biosimilars division, and one million doses of chloroquine phosphate donated by Bayer Pharmaceuticals, for possible use in treating patients hospitalized with COVID-19 or for use in clinical trials.”

Earlier, the French government had approved similar drugs to treat the virus.

Amid concerns that the sudden interest in hydroxychloroquine could cause shortages, HHS noted: “Use of the donated medications is expected to help ease supply pressures for the drug, and the FDA is also working with manufacturers of chloroquine and hydroxychloroquine to increase production to ensure these drugs also remain available for patients dependent on them for treatment of malaria, lupus and rheumatoid arthritis.”