HCQ No Longer Approved Even a Little for COVID-19
— Study after study showed no benefit, and now the FDA has had enough
A letter from the agency to the Biomedical Advanced Research and Development Authority (BARDA) detailed the FDA's concerns, including that suggested dosing regimens are "unlikely to produce an antiviral effect," and said "decreased viral shedding" from treatment with these drugs, noted in some observational studies, "has not been consistently replicated."
While current FDA guidelines did not recommend use of the drugs outside of a randomized clinical trial, the FDA also pointed to recent data from a large clinical trial showing no "evidence of benefit" for mortality, effect on hospital length of stay, or need for mechanical ventilation among COVID-19 patients treated with hydroxychloroquine.
The FDA originally granted an EUA to HCQ on March 28, 2020.
This may be the end for the controversial drug as COVID-19 therapy; study after study found no benefit in the drug among hospitalized patients or as post-exposure prophylaxis. It will remain available for its previously approved conditions, which include rheumatoid arthritis and systemic lupus erythematosus as well as malaria, and can still be prescribed off-label at physicians' discretion. Without the EUA, however, third-party reimbursement may become harder to secure for COVID-19 cases, and malpractice litigation easier to win if patients suffer adverse events. Also, access to HCQ and CQ in the National Strategic Stockpile for use in COVID-19 patients will now end.
https://www.medpagetoday.com/infectiousdisease/covid19/87066