Mayo Clinic urges caution for health care providers prescribing ‘off-label’ meds for COVID-19
Researchers are working to develop a vaccine for COVID-19. But officials at the Mayo Clinic in Rochester said it likely won’t be ready for another 12-18 months.
Now, they’re sounding an alarm to fellow health teams across the state about prescribing "off-label" medications. 5 EYEWITNESS NEWS looked into what every family needs to know.
"Off-label" is a term that’s becoming more and more common, so 5 EYEWITNESS NEWS asked Mayo Clinic Genetic Cardiologist Dr. Michael Ackerman what that really means.
"Yes, it’s a popular expression," Ackerman said. "… Off-label is when we have an FDA approved medication like hydroxychloroquine, which we are all hearing about, where that drug is an FDA-approved drug for malaria, it’s an FDA-approved drug for lupus. It is off-label for COVID-19."
Sarah Derr, executive director of the Minnesota Pharmacy Association, said that’s because the FDA still needs more evidence it works.
"It’s a very old drug. It’s been around for a very long time," she said. "It’s not something new to us, but this use is a new indication for the medication that we haven’t really seen before … There is really no evidence that it’s going to be the cure-all for COVID-19."
Still, Ackerman said doctors can prescribe off-label medications.
The good news is this medication could potentially help save somebody’s life. The tricky part is that the drugs can be deadly, depending on whom doctors prescribe it to.
@mnhealth issued a health advisory today regarding non-pharmaceutical treatments of #COVID19. Recommendations for the public are below and the full notice can be viewed at https://t.co/Rn4bv5NLVn #PreventPoison pic.twitter.com/wuTyw8hgFE— Minnesota Poison Control System (@MNpoisoncenter) March 30, 2020
"These medications have hydroxychloroquine or azithromycin, the medicines we are hearing about, they have an unwanted side effect of drug-induced sudden cardiac arrest," Ackerman said.
Ackerman said doctors who prescribe hydroxychloroquine for patients to treat the coronavirus are taking a big risk.
"I think they are taking the data that they are seeing in real time," Ackerman said. "These medications are being used and being prescribed a lot in COVID-19, and they’re being used, I would say, without a healthy dose of respect for this potential tragic side effect, and it’s the wild west out there."
The Mayo Clinic is putting out the urgent call to all providers and patients to test for what’s called their "QTc value."
"It’s kind of like Goldilocks and the Three Bears with the QT number," Ackerman said. "Too hot, too cold, just right. And so there’s a QTc range, that is just right (to safely prescribe off-label medications for the coronavirus)."