Virus patients being treated with antimalaria drug
FDA approves use of hydroxychloroquine sulfate to slow COVID-19 progression
Health experts aren’t calling it a “miracle drug,” but it has proven to be effective in treating COVID-19 patients across Michigan.
The Food and Drug Administration (FDA) has given emergency use approval to pull millions of doses of an anti-malarial drug, Hydroxychloroquine sulfate, from the Strategic National Stockpile and distribute to hospitals across the country to help slow the progression of COVID19 when treating the most seriously ill patients.
Historically, Hydroxychloroquine has been used to prevent or treat malaria infections caused by mosquito bites. It’s also used to treat certain auto-immune diseases such as lupus and rheumatoid arthritis.
Kathy Pawlicki, Beaumont’s
vice president and chief pharmacist, said the state’s largest hospital system is treating some COVID-19 patients with hydroxychloroquine. She said guidelines for COVID-19 treatment have been established.
“There are no specific anti-retroviral treatment for COVID-19 at this time,” she said. “Medications that have shown potential efficacy in the management include hydroxychloroquine. We provide recommendations on common dosing in or guidelines with duration of therapy.”
Before being considered for hydroxychloroquine, Beaumont requires patients to be either:
• Confirmed COVID-19 positive
• Moderate to severe disease with pending COVID-19 test
• Confirmed negative but highly suspicious
As Tuesday, Henry Ford Health was treating over 530 COVID-19 patients while Beaumont was treating over 900 COVID-19 patients.
Four days before the FDA approved the drug’s emergency disbursement, the
Michigan Department of Licensing and Regulatory Affairs (LARA) sent a letter to licensed prescribers and dispensers addressing the possible usage of hydroxychloroquine and chloroquine to treat symptoms of COVID-19.
The letter discussed how hoarding of the drugs could negatively impact non-coronavirus patients, such as those with lupus, rheumatoid arthritis, and other ailments for which the drugs are proven treatments, as well as possible administrative action against the licenses of physicians who prescribe it.
On March 27, LARA sent out another letter clarifying information that was included in the initial letter.
“We understand that we are dealing with an unprecedented and challenging crisis, but we must all work together to address this virus and keep ourselves, our families, our friends, and our fellow Michiganders safe. LARA appreciates the essential role of our prescribers and dispensers and recognizes their ability to make proper clinical decisions including following responsible prescribing and dispensing practices to combat drug hoarding and prevent unnecessary shortages. The Department thanks all
of the dedicated licensed health professionals and others who continue to provide the best possible care for Michigan’s citizens during this state of emergency.”
Dr. Marcus Zervos, Henry Ford Health’s head of Infectious Diseases, said the health system has been treating COVID-19 patients with hydroxychloroquine “off-label” for about three weeks. Although there have been only a few studies and clinical trials showing a possible benefit of the drug, he said those potential benefits outweigh the risks.
Around 800 COVID-19 patients in the Henry Ford Health System have been treated with hydroxychloroquine since March 1. Zervos said there aren’t any shortages of the drug within the system, one he believes is an “important therapy” for patients that are hospitalized, not for those experiencing mild symptoms and outside of a hospital setting.
“It reduces viral shedding and also has an influence on the immune system,” she said. “The goal of therapy is to take patients that have compromised respiratory systems and pneumonia and help prevent them from having further complications and ending up in the ICU or on a ventilator. We also use (hydroxychloroquine)
to get patients off ventilators sooner.”
Zervos said Hydroxychloroquine is a not a “miracle cure,” but added that studies, including those conducted in China, have shown patients administered hydroxychloroquine have had less complications and a decreased likelihood of virus progression.
In rare cases, Zervos said the drug may cause problems for patients with existing heart issues, including myocarditis, which can be treated. Longer-term use of the drug, which is not allowed under the FDA’s emergency authorization, has been associated with a chance of developing a form of vision loss called retinopathy.
“We’re learning a lot as we care for more patients,” he said.
The FDA requires that health care providers and patients are provided with fact sheets about using hydroxychloroquine sulfate in treating COVID-19. Information includes known risks and drug interactions.
In addition, the FDA is requiring hospitals and doctors to report negative side effects of the drug. Experts have also recommended screening before the drug is prescribed to prevent drugrelated deaths.