Painkiller Prexige Recalled In Australia

A PAINKILLER used by 60,000 Australians has been ordered off the shelves after the deaths of two people.

The Therapeutic Goods Administration yesterday announced the urgent recall of the drug Prexige, used to treat osteoarthritis and acute pain. Patients using the drug, also known by its chemical name lumiracoxib, are advised to stop taking it immediately and ask their doctor for an alternative prescription.

The TGA made the decision after receiving reports of eight people who suffered serious liver reactions, including two deaths and two liver transplants. Six of the reports occurred since the beginning of July.

TGA medical adviser Rohan Hammett said in a statement yesterday the drug was being recalled to prevent further cases of severe liver damage.

"It seems that the longer people are on the medicine, the greater chance of liver injury," Mr Hammett said.

Australia is the first country in the world to withdraw the drug, which is produced by Novartis Pharmaceuticals. Novartis estimates the drug has been used by about 60,000 Australians.

It is not yet known whether the 50 other countries that sell the drug will follow suit. Prexige is still awaiting approval by the US Food and Drug Administration.

Prexige went on sale in Australia in November, 2005 and gained widespread use since being listed on the Pharmaceutical Benefits Scheme in August last year. At the time, patients were warned to exercise caution with Prexige because it belonged to a family of drugs known as Cox-2 inhibitors linked with heart attack and stroke.

Cox-2 inhibitors, dubbed "super aspirin", have been under a cloud since a popular painkiller Vioxx was withdrawn in 2004 for increasing the risk of cardiovascular disease. Australia's National Prescribing Service - an independent, government-funded agency that advises doctors about the safe use of medications - warned last year that not enough was known about the long-term safety of Prexige.

Novartis spokeswoman Rebecca Fisher-Pollard urged people who used the drug not to panic. She said liver damage was known as a possible side effect but the incidence was rare.

"The information has always been there," Ms Fisher-Pollard said.

Novartis has set up a patient helpline to answer queries. Patients are advised to return any unused Prexige tablets to their pharmacist, who will give them a full refund. All GP groups and pharmacists have been alerted about the drug recall.

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Cardiac Surgery In Patients With Severe Liver Cirrhosis Less Likely To Survive

Amy Molnar

A new study on the outcome of cardiac surgery in patients with liver cirrhosis found that the surgery can safely be performed in patients with milder disease, while those with more severe cirrhosis are less likely to survive.
The results of this study appear in the July 2007 issue of Liver Transplantation, the official journal of the American Association for the Study of Liver Diseases (AASLD) and the International Liver Transplantation Society (ILTS). The journal is published on behalf of the societies by John Wiley & Sons, Inc. and is available online via Wiley InterScience at http://www.interscience.wiley.com/journal/livertransplantion.
In abdominal surgery, it is well known that the severity of liver cirrhosis, as measured by the Child-Pugh classification (a scoring system used to gauge the severity of liver disease) correlates directly with surgical outcome. However, few studies have reported how these patients fare when undergoing cardiac surgery.
Led by Farzan Filsoufi, of Mt. Sinai Hospital in New York, NY, researchers conducted a retrospective study of patients who underwent cardiac surgery at Mt. Sinai Medical Center between January 1998 and December 2004, and identified 27 patients who had cirrhosis. Of these, 18 patients had cardiac surgery with cardiopulmonary bypass (heart-lung machine) while the other 9 had surgery without using the heart-lung machine.
The results showed that hospital mortality increased significantly according to the Child-Pugh classification, with a mortality rate of 10 percent for those with class A, 18 percent for those with class B, and 67 percent for those with class C. Postoperative complications were also higher in class B and C than in class A. There was no correlation between mortality and the MELD (Model for End-Stage Liver Disease) score, however. Early studies reported a higher mortality for class B and C patients than seen in this study, but more recent studies have shown an improvement in survival rates. The current study confirms lower mortality for class B patients, which is probably due to improvements in surgical techniques and the management of cardiac surgery patients. In addition, there was no mortality for those who had coronary artery bypass surgery off-pump (without the heart-lung machine).
The authors note that alternative treatment strategies are needed for patients with advanced cirrhosis and cardiovascular diseases that require surgery. One potential approach is a combined liver transplant and cardiac operation, and there have been a few positive reports documenting such cases. "Despite early promising results with this combined approach the number of publications remains very limited and further investigations are required to determine the role of this treatment strategy in the armamentarium of cardiac and transplantation surgeons," the authors state. Although hospital mortality decreased in this study, the rates of postoperative complications in class B and C were 55 percent and 100 percent respectively. Surgical trauma and the deleterious effects of cardiopulmonary bypass may explain the increased rate of complications, according to the authors.
The authors conclude that "cardiac surgery can be performed with low operative mortality and good mid-term survival in patients with Child-Pugh class A." Acceptable results are also possible with class B patients, especially those who do not have surgery using the heart-lung machine, while for class C patients, who have cardiac surgery because of a life threatening condition, operative mortality remains high. The authors conclude: "Careful selection is critical in order to improve surgical outcome in patients with liver cirrhosis."
In an accompanying editorial in the same issue, Gonzalo Gonzalez-Stawinski, of Cleveland Clinic in Cleveland, OH, notes that cirrhotic patients requiring open heart surgery are among the most challenging and complex patients seen in cardiac surgery. The author notes that the current study raises the question of whether elective cardiac interventions should be offered to patients with advanced cirrhosis, in the hopes of improving their survival and quality of life. He states that "caution needs to be exercised when taking on cirrhotic patients as data provided by Filsoufi, et. al would suggest that most patients with either Childs-Pugh B or C do not gain a survival advantage by correcting their cardiac pathology." As an alternative, he suggests delaying and medically managing their heart disease in the hopes that they can undergo combined cardiac surgery and liver transplant, although not all patients would want or be eligible for such a solution and only a handful of centers in the U.S. have the capabilities to undertake it. He concludes, "Despite the challenges linked to the cirrhotic cardiac surgery patient, cardiac surgeons and hepatologists/liver transplant specialists need to continue to work in unison in hopes of improving the outcomes associated to this difficult patient population."

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