Last week, the FDA approved an abbreviated new drug application for another generic version of heparin sodium, a product that has been on the federal regulator’s shortage list even though the pandemic has increased the need for the therapeutic. A critical feature of COVID-19 has been its proclivity for generating clots, making blood-thinning medications a frequent part of care for people hospitalized with the disease.
So far this year, 104 drugs have been added to the FDA’s drug shortage list, according to an analysis by HRI. Drug shortages are not uncommon; the FDA has been adding and removing products from its shortage lists for years, often for manufacturing issues or a lack of an active pharmaceutical ingredient. But with the global pandemic, drugs are being added to the list because of delays in shipping as supply chains around the world have become compromised. Some drugs are on the list because of demand increase due to COVID-19.
Several categories of drugs stand out. The corticosteroid dexamethasone is on the list after a large trial offered evidence that it can help treat hospitalized COVID-19 patients. Nearly 130 anesthesia and 17 analgesia drugs—products often used for intubated patients—are in short supply. Aside from those essential drugs needed for sedation and pain management, hospitalized COVID-19 patients also can develop heart and kidney problems. Currently, 32 cardiovascular and nine renal drugs are on the list. Seventeen psychiatric treatments also are on the shortage list.
Hydroxychloroquine, a drug used primarily to prevent malaria, gained notoriety after a small European study showed benefit for COVID-19. That study has since been withdrawn; large new trials have pointed to its ineffectiveness. The drug remains in shortage nonetheless. The antibiotic azithromycin likely landed on the list for the same reason, after it was shown in some small studies to boost the effectiveness of hydroxychloroquine in treating COVID-19.
As cases of COVID-19 surge around the US, the FDA has been put in the difficult position of managing the drug supply, particularly for pharmaceuticals that may not have been in high demand previously and those drugs that were already in short supply.
The pandemic has highlighted the weaknesses in the drug supply chain, and increased trade tensions have further compounded the problems of bringing drugs to the US from parts of the world that commonly supply active ingredients. (Read more about COVID-19 is affecting the supply chain here and here.)