An "ongoing and long-term problem." That's how the FDA characterized the U.S. propofol shortage back in March, and in the past week, the problem appears to have gotten much worse, as Teva Pharmaceuticals announced it would cease making propofol and Hospira recently issued a fresh recall of the sedative.
Teva stopped manufacturing propofol in mid-April, formally decided not to re-enter the market on May 26 and currently is not shipping any propofol, says Denise Bradley, Teva's senior director of North American corporate communications. The decision was a financial one: "Ultimately, it is because the product in its current formulation is difficult to manufacture and has little to no profitability."
Because of the recent shortage, which has thrown the propofol market off-balance, Ms. Bradley says she's not sure what Teva's most recent share of the market has been, but the company estimates that it has historically supplied about 40% of the nation's propofol.
Since manufacturing problems at both Teva and Hospira, the 2 major U.S. suppliers of generic propofol, disrupted the market last year, European manufacturer APP "has been covering the majority of the market," says Crystal Rice of the FDA's Center for Drug Evaluation and Research. Ms. Rice says the FDA is working with APP to further increase supplies, "and Hospira is also working to return to the market as quickly as possible."
A spokesman for Hospira confirms that the company has improved its manufacturing process for propofol and resumed production, but hasn't released any new propofol yet because the FDA is still reviewing its manufacturing changes. "We will release the product once we have the agency's approval," he says. "We can't speculate on the timing."
Meanwhile, just this week Hospira announced it was expanding a voluntary recall of certain lots of propofol injectable emulsion 1%, as well as Liposyn intravenous fat emulsion, saying that "some of the containers may contain particulate matter made up of sub-visible inert stainless steel particles." The recall, which began March 31 and was expanded this week, affects propofol lots beginning with numbers 66 through 78, and 82 through 85.
See the American Society of Health-System Pharmacists' website and the FDA's Current Drug Shortages page for updates on the availability of propofol. Contact the FDA's Drug Shortage Program at drugshortages@fda.hhs.gov with questions or concerns about obtaining anesthetics in short supply.
Irene Tsikitas
