Propofol discontinued by maker; widely used sedative figured in Jackson death

By Associated Press
Saturday, May 29, 2010

The drugmaker Teva said Friday that it will not make any more of its sedative propofol, a decision that could intensify a shortage of one of the most common anesthetics in the United States.

The drug is hard to manufacture, and the company gets little or no profit from it, said Denise Bradley, a spokeswoman for Teva Pharmaceutical Industries. The company 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.

Alexander Hannenberg, president of the American Society of Anesthesiologists, said propofol is by far the most common intravenous anesthetic used in the United States, because when it is administered properly, patients wake up quickly and side effects are rare. Hannenberg said the drug is often used in surgeries and is becoming more popular in procedures such as spinal or epidural anesthesia.

"Probably at least 75 percent of the anesthetics given in the U.S. involve propofol," he said. "It's huge."

Propofol was connected to the death last year of Michael Jackson. The singer died in June after overdosing on sedatives administered by his doctor, who has been charged with involuntary manslaughter. Conrad Murray used the drugs to help Jackson sleep.

The Food and Drug Administration says there has been a shortage of the drug since last fall because manufacturing problems forced both Teva and Hospira Inc. to suspend manufacturing and recall some of their versions of the sedative. With no U.S. companies making the drug, the agency authorized the importation of a version approved in Europe.

The FDA said the European manufacturer, APP Pharmaceuticals, is covering most of the demand for propofol and it is working with APP to increase supplies.

Teva, based in Israel, has not made any propofol since mid-April, but plans to sell what it had already made. Hospira, based in Lake Forest, Ill., said it cannot resume selling the drug until the FDA approves changes to its manufacturing procedures.

Few companies make propofol because it is complicated to manufacture. It's an emulsion -- a combination of two liquids that don't blend together chemically -- and it must be stored very carefully because bacteria can contaminate it more easily than other drugs.

Further complicating matters is the fact that some of the drugs that could be used in place of propofol also are in short supply, Hannenberg said.

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