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Teva Discontinues Propofol in the Wake of FDA GMP Concerns and Lawsuit Verdict

Jun 1st, 2010

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In the wake of GMP concerns resulting in an FDA warning letter and recall, and a clinical practice-related lawsuit verdict involving heavy punitive damages, Teva announced on May 28 that it will discontinue manufacturing its generic injectable emulsion version of the sedative propofol.

In July 2009, Teva issued a nationwide recall of some lots of its injectable propofol because of elevated endotoxin levels after at least 40 people became ill following use of the product.  In December, FDA issued a warning letter to Teva citing the problems in controlling microbial contamination and endotoxin in final product.  Hospira also issued a propofol recall due to quality problems in November. The Teva and Hospira recalls led to a US shortage of the drug beginning in the Fall of 2009.  [IPQ “In the News” April 28]

In announcing that it will discontinue propofol manufacturing, Teva did not comment on the motivation for its decision.  The firm said it will continue marketing doses that have already been made. FDA confirmed there remains a shortage of propofol in the market.

In early May, Teva was found liable in a lawsuit in Las Vegas district court, and ordered to pay $356 million in damages to a plaintiff who claimed he contracted hepatitis C when one of Teva’s propofol vials was used by more than one patient.

The jury also awarded $144 million in punitive damages against Baxter International Inc., which distributed the product.  Both firms plan to appeal the verdict.  In addition to the punitive damages, the plaintiff was awarded $5.1 million in compensatory damages.

Further analysis of Teva’s propofol issues as well as links to the Teva and Hospira warning letters and FDA’s release on propofol shortages are provided in the full story available to subscribers on page 2.

Editor’s Note:  The June issue of IPQ will provide an in-depth report on the changing inspection and GMP enforcement landscape in the US, EU, and globally.

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