Teva To Stop Manufacturing Propofol – With No US Manufacturers Left FDA Approved Import From Europe
Posted May 28 2010 5:23pm
If this drug name sounds familiar, think back a short while to Michael Jackson, this was the drug that he had at home, used only in hospital settings and now with Teva , the generic drug manufacturer having stopped production, all US supplies will have to be imported. Teva actually stopped production in the US in mid April.
In addition to FDA issues Teva said they were not making any money and there were recalls last year and there some law suits hanging around. There is a company that cannot resume selling it in Chicago but not until the FDA approves the changes at the manufacturing plant. Here’s the history from last year.
Anesthetics could become in short supply and that’s what is used in surgery to “put us under” as stated below 75% of surgeries in the US involve propofol. I hope Europe has a big supply to handle this. APP Pharmaceuticals is the company to fill in the shortages. BD
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.
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
"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.
Hospira, based in Lake Forest, Illinois, 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.