March 30, 2010
The Wall Street Journal Reports Teva Will Stop Making Propofol
Teva Pharmaceutical Industries Ltd. has told federal regulators that it will stop making the anesthetic propofol.
The injectable drug is one of the most widely used medicines for general anesthesia or sedation in operating rooms and intensive care units.
Doctors and the Food and Drug Administration have been concerned about a potential drug shortage since last fall.
Teva recalled some of the product in July 2009 after elevated levels of toxins were discovered at its Irvine, Calif., plant. The FDA said in a Dec. 11, 2009, warning letter released last month that it found "significant" manufacturing violations at the plant.
In a statement, the Israeli company said it is discontinuing its manufacture of propofol. "Our data supports that these products, when used and stored as directed, continue to be safe and effective and perform within the appropriate specification."
An FDA spokeswoman said propofol is still on its drug-shortage list. In November, the FDA took the unusual step of allowing APP Pharmaceuticals Inc., a subsidiary of Fresenius Kabi Pharmaceuticals Holding Inc., to import a similar product from one of its plants in Europe, after concerns about the shortage were raised by the American Society of Anesthesiologists.
The remaining U.S. propofol maker, Hospira Inc., has had two recalls, most recently on March 31. Hospira is not currently selling the product, a spokesman said. "We're implementing manufacturing changes to prevent the recurrence of a previous issue, and working with the FDA," he said.