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Hydroxychloroquine (HCQ) remains a safe drug for approved indications. Patients with rheumatoid arthritis and lupus should continue taking this for their conditions if prescribed by a doctor
While we at FDA wait for data from controlled trials to determine the safety and efficacy of HCQ for the treatment of #COVID19, physicians should make the decision about prescribing HCQ while assessing the risks and benefits in the context of the doctor-patient relationship.
.@US_FDA does not regulate the practice of medicine. The Agency neither endorses nor prohibits physicians from prescribing medications. Physicians prescribe drugs for patients with #COVID19 based on an assessment of the potential benefits versus risks for an individual patient.
Doctors and patients should have conversations and decide the best treatment for #COVID19 just like they would in any other clinical situation. Check out my latest FDA Voices post at go.usa.gov/xwT5z
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Dr. Stephen M. Hahn
@SteveFDA
FDA issued an Emergency Use Authorization (EUA) to Gilead Sciences, Inc. for the investigational antiviral drug remdesivir – which has been shown to shorten recovery time in some #COVID19 clinical trial patients – to treat suspected or confirmed #COVID19. fda.gov/news-events/pr…
This EUA allows for remdesivir to be distributed in the U.S. & administered intravenously in adults & children with severe #COVID19 disease, defined as low blood oxygen levels or needing oxygen therapy or more intensive breathing support, like a ventilator.
Issuing an EUA is different than FDA approval. In determining whether to issue an EUA, FDA evaluates the available scientific evidence very quickly and carefully balances any known and potential benefits and/or risks of these products to the public.
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Dr. Stephen M. Hahn
@SteveFDA
While clinical trials are ongoing to determine the safety and effectiveness of hydroxychloroquine and chloroquine for #COVID19, there are known side effects of these medications that should be considered. fda.gov/news-events/pr…
FDA issued a Drug Safety Communication regarding known side effects of hydroxychloroquine & chloroquine, including potentially life-threatening heart rhythm problems, reported with their use for treatment or prevention of #COVID19, for which they are not FDA-approved.
We understand that health care professionals are looking for every possible treatment option for their patients and we want to ensure we’re providing them with the appropriate information needed to make the best medical decisions.
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Dr. Stephen M. Hahn
@SteveFDA
Based on prior experience with respiratory viruses & on data from China, convalescent plasma – the plasma from the blood of recovered #COVID19 patients – may potentially lessen severity or shorten the illness caused by #COVID19. fda.gov/news-events/pr…
FDA is facilitating access to convalescent plasma to treat #COVID19 using multiple pathways. Our initial effort focused on emergency investigational new drug applications (eINDs), & we provided info to help health care providers submit applications to treat individual patients.
FDA is also facilitating the conduct of well-controlled clinical trials at academic institutions across the U.S. to evaluate the safety & efficacy of convalescent plasma for use in #COVID19 patients.
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