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

By Marley Seaman, AP
Friday, May 28, 2010

Teva won’t make any more of a powerful sedative

NEW YORK — The drugmaker Teva said Friday it won’t make any more of its sedative propofol, which could intensify a shortage of an anesthetic widely used in operating rooms.

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.

Teva is also facing almost 250 lawsuits connected to the drug.

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.

Teva, which is 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 Divipran, but no longer sells it.

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.

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, which is based in Israel, 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 41 cents to $55.29 in midday trading Friday. Hospira stock rose 41 cents to $52.49.

YOUR VIEW POINT
NAME : (REQUIRED)
MAIL : (REQUIRED)
will not be displayed
WEBSITE : (OPTIONAL)
YOUR
COMMENT :