FDA SAYS THERE’S A SHORTAGE OF HYDROXYCHLOROQUINE AND CHLOROQUINE ‘DUE TO A SIGNIFICANT SURGE IN DEMAND’
The U.S. is facing shortages of antimalarial drugs being used experimentally to treat COVID-19 patients, according to the Food and Drug Administration (FDA).
Both hydroxychloroquine and chloroquine, which are used to treat malaria, lupus and rheumatoid arthritis, are listed as “currently in shortage” by the agency. This is “due to a significant surge in demand,” the body said.
The FDA stated: “all manufacturers are ramping up production” and the agency is ensuring this is happening “expeditiously and safely.”
The announcement follows FDA approval of the drugs for use in patients hospitalized by and in clinical trials for the treatment of COVID-19, after it issued the first Emergency Use Authorization for a drug related to the disease over the weekend.Ads by scrollerads.com
The U.S. Department of Health and Human Services (HHS) said in a statement on Sunday that it accepted 30 million doses of hydroxychloroquine sulfate from an arm of the pharmaceutical company Novartis, and one million of chloroquine phosphate from Bayer Pharmaceuticals.
On Wednesday, the FDA said the 30 million doses “is expected to help ease supply pressures for the drugs.
“This is a fluctuating and dynamic situation and the FDA is actively engaged. The agency is updating its shortages lists regularly and continuing to communicate in real-time so that patients and healthcare providers have the most current information on product shortages in the U.S.”
Explaining the reasoning behind the FDA giving the green light for the medications on Sunday, the HHS said: “Anecdotal reports suggest that these drugs may offer some benefit in the treatment of hospitalized COVID-19 patients. Clinical trials are needed to provide scientific evidence that these treatments are effective.”
Experts who spoke to Newsweek at the time agreed that clinical trials must be carried out to prove the drugs are safe and effective in COVID-19 patients.
Andrew Preston, reader in microbial pathogenesis at the U.K.’s University of Bath, told Newsweek: “The desperate clinical need for treatment options for COVID-19, and the pressure that authorities are under to provide answers/solutions, and to be shown to providing them, it is perhaps understandable as to why the FDA has moved to approve chloroquine and hydroxychloroquine use, before the firm evidence supporting their use is available.”
The FDA also announced on Wednesday that it had warned three companies for selling “fraudulent products with claims to prevent, treat, mitigate, diagnose or cure COVID-19.”
The U.S. is now the country with the most confirmed COVID-19 cases. As indicated by the Statista map below, it has spread to all 50 states, Washington D.C., and four U.S. territories. According to Johns Hopkins University, over 190,000 cases have been confirmed.