Teva won’t make any more of its version of powerful sedative propofol already in short supply

Teva won’t make more of powerful sedative propofol

NEW YORK — The drugmaker Teva said Friday it won’t make any more of its sedative propofol, which could intensify a shortage of one of the most common anesthetics in the U.S.

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 Ltd. 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.

Dr. Alexander Hannenberg, the president of the American Society of Anesthesiologists, said propofol is by far the most common intravenous anesthetic in the U.S., used for general anesthesia and for sedation because when it’s used 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 like spinal or epidural anesthesia.

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

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.

Britain’s AstraZeneca PLC developed the brand name version of the drug, which is called Diprivan, but no longer sells it.

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. Sodium pentathol might be used as an alternative for general anesthesia, but right now it’s extremely hard to get. He said the problem is that many of these drugs are made by few companies, or only one company, so they are hard to replace when supply problems strike.

Hannenberg, a practicing anesthesiologist, said drugs like Valium might be used as sedatives in place of propofol. But pentathol and Valium are more likely to produce side effects including nausea.

In 2008, propofol was connected to a hepatitis C outbreak that infected as many as 114 people. Vials of propofol were allegedly used to treat more than one patient each, spreading the liver disease. Close to 250 lawsuits have been filed in connection with the outbreak.

Earlier this month, a court ordered Teva to pay $356 million to a man who said he contracted hepatitis C from a vial of propofol. Teva’s partner, Baxter International Inc., was ordered to pay $144 million. The plaintiff said Teva and Baxter encouraged unsafe reuse of the drug by selling it in unnecessarily large vials.

Both companies have said they plan to appeal that verdict, and Teva said that if the man contracted hepatitis C from the clinic, it was because the drug was “blatantly misused.” Teva said it believes propofol is safe and effective when it is used properly.

The drug became infamous last year when it was connected to the death of Michael Jackson. The singer died in June after overdosing on propofol and other sedatives that were administered by his personal doctor, who has been charged with involuntary manslaughter. Dr. Conrad Murray used the drugs to help Jackson sleep.

Teva shares fell 97 cents to $54.73 in afternoon trading Friday. Hospira stock rose 33 cents to $52.41.