Michigan regulators warn against prescribing anti-malaria drugs for virus
As COVID-19 cases rise in Michigan, state regulatory officials are cautioning prescribers and pharmacies about doling out to themselves and others anti-malaria drugs that may hold promise in treating the disease.
The state Department of Licensing and Regulatory Affairs "has received multiple allegations of Michigan physicians inappropriately prescribing hydroxychloroquine or chloroquine to themselves, family, friends, and/or coworkers without a legitimate medical purpose," officials said in a statement Tuesday.
The warning comes as preliminary studies have sparked intense interest after President Donald Trump talked during daily briefings about the virus and has tweeted that hydroxychloroquine plus an antibiotic could be “one of the biggest game changers in the history of medicine” and should “be put in use immediately.” He cited a French study that gave the combo to six patients.
Currently, there is no medicine specifically approved for treating COVID-19, the disease caused by the new coronavirus, which through Tuesday state officials said had led to 24 deaths and nearly 1,800 confirmed cases in Michigan.
"Prescribing hydroxychloroquine or chloroquine without further proof of efficacy for treating COVID-19 or with the intent to stockpile the drug may create a shortage for patients with lupus, rheumatoid arthritis, or other ailments for which chloroquine and hydroxychloroquine are proven treatments. Reports of this conduct will be evaluated and may be further investigated for administrative action," the LARA statement said.
Chloroquine and a similar drug, hydroxychloroquine, have shown encouraging signs in small, early tests against the coronavirus. But the drugs have major side effects, one reason scientists don’t want to give them without evidence of their value, even in this emergency.
Scientists warn about raising false hopes and say major studies are needed to prove the drugs are safe and effective against coronavirus, and to show that people would not have recovered just as well on their own.
"These are drugs that have not been proven scientifically or medically to treat COVID-19," LARA said.
The department warned that state pharmacists "may see an increased volume of prescriptions for hydroxychloroquine and chloroquine and should take special care to evaluate the prescriptions’ legitimacy."
"A pharmacist shall not fill a prescription if the pharmacist believes the prescription will be used for other than legitimate medical purposes or if the prescription could cause harm to a patient," it said.
Chloroquine has been used to treat malaria since the 1930s. Hydroxychloroquine, a similar drug, came along a decade later and has fewer side effects. The latter is sold in generic form and under the brand name Plaquenil for use against several diseases.
The drugs can cause heart rhythm problems, severely low blood pressure and muscle or nerve damage. Plaquenil’s label warns of possible damage to the retina, especially when used at higher doses, for longer times and with certain other medicines such as the breast cancer drug tamoxifen.
Hydroxychloroquine curbed coronavirus’ ability to enter cells in lab tests, researchers reported last week in the journal Nature Medicine. That doesn’t mean it would do the same in people or that they could tolerate the doses tested in the lab.
A report from China claimed chloroquine helped more than 100 patients at 10 hospitals, but they had various degrees of illness and were treated with various doses for different lengths of time. They also might have recovered without the drug — there was no comparison group.
Some people have tried to take matters into their own hands, with deadly consequences. A Phoenix-area man died and his wife was in critical condition after taking chloroquine phosphate, an additive used to clean fish tanks. The cleaning agent has the same active ingredient as the medicine chloroquine but is formulated differently.
Dr. Daniel Brooks of Banner Health Care’s poison center in Phoenix urged people not to self-medicate.
“The last thing that we want right now is to inundate our emergency departments with patients who believe they found a vague and risky solution,” he said.