Propofol Demand Remains High Despite Controversy
Where there were two U.S. drug manufacturers of the popular sedative drug propofol, now there are none. Teva Pharmaceuticals Industries announced May 28 that it would continue to market its current supply but would make no more of the anesthetic. Hospira Inc. suspended production of the drug last month. Both companies have dealt with a multitude of propofol-related manufacturing problems.
Teva USA had to halt production and recall some of the drug last year because of manufacturing issues, and it is facing a raft of propofol-related civil lawsuits, reports ABC News.
Hospira, located in Lake Forest, Ill., announced May 27 that it is voluntarily expanding its March 31 recall of injectable propofol. The affected lot numbers are shown in the table below:
|Product||All lot numbers beginning with:||Expiration date range|
|Propofol||66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 82, 83, 84, 85||June 1, 2010 through
January 1, 2012
Hospira is conducting the recall because some of the containers may contain particulate matter. Since these particulate contaminants do not dissolve in blood, they could potentially act as emboli and impede blood flow. Particulates may also cause mechanical damage to the body and may escalate damage through Systemic Inflammatory Response Syndrome (SIRS). Restriction in blood supply to tissues could lead to stroke, respiratory failure, kidney failure, liver failure, heart attack and/or death.
Although propofol production in the United States has come to a screeching halt, the demand for the drug has not. In response, the U.S. Food and Drug Administration (FDA) is temporarily permitting European drug maker APP Pharmaceuticals to import and distribute an unapproved Propoven 1 percent (propofol 1 percent) within the United States.
Read a Dear Healthcare Provider Letter from APP regarding the FDA’s steps to alleviate the drug shortage.
The FDA also announced June 4 that Hospira has since implemented improvements to its manufacturing process and is coordinating with the federal agency to begin distribution of propofol under the new process as soon as possible.
In other news … the FDA also announced on June 4 drug shortages for epinephrine emergency syringes and heparin sodium large volume premixed infusion solutions.