Shortage of Malaria Drug With Possibilities for COVID-19 Treatment

Four out of 8 manufacturers of hydroxychloroquine, an anti-malarial drug that had shown some success treating the symptoms of the novel coronavirus (COVID-19), are already experiencing shortages according to a list from the American Society of Health-System Pharmacists (ASHP).¹

According to ASHP’s list of drug shortages, which is independent of the FDA, 200 mg hydroxychloroquine sulfate tablets from Amneal, Major, Mylan, and Teva are currently experiencing shortages. Concordia, Prasco, Sandoz, and Zydus have not reported shortages at this time.¹

The drug has experienced surging demand following President Donald Trump’s comments at a White House briefing, in which he urged regulators to expedite potential therapies for COVID-19, including hydroxychloroquine.²

In response to the new demand, Mylan has announced that it will increase production at its West Virginia facility as well as abroad.³

“Although the product is not currently approved for use in the treatment of COVID-19, it is listed by the World Health Organization as a drug under investigation for efficacy against the coronavirus,” the company said in a press release.³

Mylan plans to be able to begin supplying the product by mid-April and will be able to provide 50 million tablets to potentially treat more than 1.5 million patients, according to the press release.³

In studies for its anti-malarial effects, adverse reactions to hydroxychloroquine included mild and transient headaches, dizziness, and gastrointestinal complaints.⁴

Bayer AG has also donated 3 million chloroquine phosphate tablets, a closely related drug also approved to treat malaria. Although the drug is not currently approved for use in the United States, Reuters reported that Bayer is working to get an emergency use authorization from the FDA.⁴

According to ASHP, Amneal has hydroxychloroquine 200 mg tablets in 100 count bottles on allocation, and Major has 50 count and 100 count bottles in limited supply. Mylan has 200 mg tablets in 100 count on back order, but the company cannot estimate a release date. Teva also has 200 mg tablets in 100 and 500 counts on backorder, and has estimated a mid- to late-March release data for both.¹

REFERENCES

• Hydroxychloroquine Sulfate Tablets. American Society of Health-System Pharmacists; March 19, 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=646. Accessed March 20, 2020.
• Erman M. Potential coronavirus treatment touted by Trump already in shortage, pharmacists say. Reuters; March 19, 2020. https://www.reuters.com/article/us-health-coronavirus-usa-shortages-excl/potential-coronavirus-treatment-touted-by-trump-already-in-shortage-pharmacists-say-idUSKBN2163JD. Accessed March 20, 2020.
• Mylan Ramps Up U.S. Manufacturing of Hydroxychloroquine Sulfate Tablets to Meet Potential COVID-19 Patient Needs [news release]. Mylan; March 19, 2020. http://newsroom.mylan.com/2020-03-19-Mylan-Ramps-Up-U-S-Manufacturing-of-Hydroxychloroquine-Sulfate-Tablets-to-Meet-Potential-COVID-19-Patient-Needs. Accessed March 20, 2020.
• Plaquenil Hydroxychloroquine Sulfate, USP. FDA; 2007. https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/009768s041lbl.pdf. Accessed March 20, 2020.
• Maddipatla M. Bayer donates three million malaria tablets to U.S. for potential use against coronavirus. Reuters; March 19, 2020. https://www.reuters.com/article/us-health-coronavirus-bayer/bayer-donates-three-million-malaria-tablets-to-us-for-potential-use-against-coronavirus-idUSKBN21637E. Accessed March 20, 2020.