FDA reports more shortages of drugs used to put Covid-19 patients on ventilators
Increasing demand for sedatives used to help put Covid-19 patients onto ventilators means the FDA added two more — this time the injectables propofol and dexmedetomidine — to its list of drug shortages.
The propofol shortage was also previously listed by the American Society for Health-System Pharmacists (ASHP) earlier this month, with manufacturers noting increased demand. Michael Ganio, senior director of pharmacy practice and quality at ASHP, previously told Focus via email: “We have multiple reports of increases in purchases and utilization of sedatives like midazolam, fentanyl, and propofol to treat COVID-19 patients who require mechanical ventilation.”
In FDA’s propofol shortage listing, generic drugmaker Dr. Reddy’s said it expects to resupply in October. Information is still pending from Sagent Pharmaceuticals, Fresenius Kabi and Teva Pharmaceuticals, although Sagent told ASHP that it has propofol 20 mL, 50 mL, and 100 mL vials on allocation.
The FDA listing for Pfizer’s Hospira, meanwhile, says that for 1000 mg/100 mL (10 mg/mL) Single Dose/Single Patient Use Glass Fliptop Vials, supplies will recover next month. But for two other versions of its propofol, supplies are not expected until August. Pfizer told ASHP that it has propofol 20 mL, 50 mL, and 100 mL vials available in limited supply.
A Pfizer spokesperson told Focus via email: “As of today, Pfizer’s manufacturing and distribution network continues to operate at high performance with no operational disruptions due to Covid-19. Historically, Pfizer has had a market share of approximately 15% for Propofol. We recently have observed an unprecedented surge in demand for Propofol beyond Pfizer’s historical demand which is limiting our ability to fully satisfy customer orders in the short-term. We are making every effort to advance the ordering of additional materials, increase our production, reduce lead times and expedite orders to customers, especially those in high-impact areas.”
In addition, the injectable sedative dexmedetomidine was listed by FDA on Friday as being in shortage. Sandoz said Monday that it’s discontinuing its production of the drug, which is indicated for the sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. But several manufacturers of dexmedetomidine said they expect supplies to be back next month.
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RAPS: First published in Regulatory Focus™ by the Regulatory Affairs Professionals Society, the largest global organization of and for those involved with the regulation of healthcare products. Click here for more information.