Video: Knock on Wood| Webinar: ACR/CHEST ILD Guidelines in Practice

An official publication of the ACR and the ARP serving rheumatologists and rheumatology professionals

FDA Accelerates Approvals of Generic Versions of HCQ

U.S. Food and Drug Administration  |  

On April 7, the FDA approved an Abbreviated New Drug Application (ANDA) for Hydroxychloroquine Sulfate Tablets USP, 200 mg, for the treatment of: 1) uncomplicated malaria due to P. falciparum, P. malariae, P. ovale and P. vivax; 2) chronic discoid lupus erythematosus and systemic lupus erythematosus in adults; and 3) treatment of acute and chronic rheumatoid arthritis in adults.

Side effects of hydroxychloroquine include irreversible retinal damage, cardiac effects (including cardiomyopathy and QT prolongation), worsening of psoriasis and porphyria, proximal myopathy and neuropathy, neuropsychiatric events and hypoglycemia.

ADVERTISEMENT
SCROLL TO CONTINUE

The FDA recently posted information regarding shortages of hydroxychloroquine and chloroquine to its drug shortages webpage due to a significant surge in demand. The agency is working with manufacturers to assess their supplies and is actively evaluating market demand for patients dependent on hydroxychloroquine and chloroquine for treatment of malaria, lupus and rheumatoid arthritis.

Reference

ADVERTISEMENT
SCROLL TO CONTINUE
  1. U.S. Food and Drug Administration. News release: Coronavirus (COVID-19) update: Daily roundup April 7, 2020. 2020 Apr 7.

Editor’s note: The ACR offers recommendations regarding the allocation of hydroxychloroquine (HCQ) during the COVID-19 pandemic and recommendations regarding the allocation of IL-1 and IL-6 and JAK antagonists during the pandemic. All recommendations are based on current knowledge and are subject to revision as circumstances evolve.

Related Articles
    nukeaf / shutterstock.com

    The History of Treating Lupus with Hydroxychloroquine

    Given how unexpectedly front and center hydroxychloroquine has been in discussions about the treatment of COVID-19 this year, it makes sense to look at how it became so central to the treatment of a rheumatologic condition. In 1991, an article appeared in The New England Journal of Medicine that would alter the way rheumatologists approached…

    Ocular Disease Monitoring Critical to Avoid Retinal Toxicity from Hydroxychloroquine

    Both due to its efficacy and favorable side effect profile when compared with alternative drugs for rheumatologic conditions, hydroxychloroquine is an important agent in rheumatologists’ armamentarium. However, one barrier to hydroxychloroquine use can be its effects on the eye (also see “Revised Retinopathy Screening Guidelines,”). Ocular side effects of hydroxychloroquine can include impact on the…

    Plaquenil: From Malaria Treatment to Managing Lupus, RA

    In 1984, I wrote my first prescription for the antimalarial drug, hydroxychloroquine (Plaquenil), for a 28-year-old woman with SLE. She was considerably overweight, with inflammatory arthritis and a photosensitive rash, and I worried that oral corticosteroids would tip her over into diabetes. I presented the case to my attending, Steven Malawista, MD, at the Yale…