Surgery News - November 2007 - (Page 15)

NOVEMBER 2007 • SURGERY NEWS PRACTICE TRENDS low, medium, or high volume, the survival differences became nonsignificant for lowvolume hospitals, although they remained significant for facilities that had higher volumes. Similarly, when blacks and whites were stratified by income (lowest vs. two highest income quartiles for their ZIP codes), the survival differences became nonsignificant. But these changes may not explain the entire picture of disparity. The key probably lies in the patients’ presurgery health status, Dr. Nathan said. “Someone who has not gotten the preoperative care that they need is more likely to have a poor outcome after surgery.” ■ Presurgery Health Status Is Key Liver Surgery • from page 1 In-Hospital Mortality After Major Liver Surgery 11% neoplastic disease, than were whites. Comorbidities were significantly more common among black patients. Blacks were also significantly more likely than were whites to receive blood transfusions (31% vs. 20%), probably due to increased cases of cirrhosis, Dr. Nathan said. Overall, whites had the lowest rate of in-hospital mortaliOverall, whites had ty after their surgery (5%) and blacks had the lowest rate of the highest (11%). in-hospital mortality after their Blacks also died surgery and blacks sooner after their surgery than did had the highest. whites (7 days vs. 16 DR. NATHAN days), perhaps because they were in poorer health prior to surgery and had lower physiologic reserves than did their counterparts. Even after adjustment for age, gender, nonelective surgery, insurance status, hospital volume, and Charlson score, blacks were still twice as likely as were whites to die in the hospital after their liver surgery. Continued from previous page risk information, partly by testing potential alternatives on consumers. The FDA is to issue its report on these efforts within a year. For the first time, the FDA also will collect fees from drug or device makers who voluntarily submit direct-to-consumer television advertisements for prebroadcast review. Sen. Kennedy applauded other new restrictions on direct-to-consumer advertising. “Instead of the moratorium included in our original bill, the current proposal puts in place strong safety disclosures for DTC ads, coupled with effective enforcement,” he said. Finally, the new law seeks to prevent outside advisory committee members with conflicts of interest from participating in deliberations on drugs or devices. A panelist would be barred if he or she has a financial interest that would be affected. However, the FDA commissioner will have the power to grant waiver in a variety of situations. ■ To tease out the possible impact of clinical factors, Dr. Nathan examined mortality in patients without cirrhosis or hepatitis; without both cirrhosis and hepatitis; and in those relatively healthy patients whose Charlson score was 0. In all these subgroups, blacks still ran a significantly increased risk of in-hospital death, with odds ratios of 2.2-2.7. Some hospital and socioeconomic factors did slightly mediate the risk of death, he said. When hospitals were stratified by 5% Whites Blacks Note: Based on data from 3,562 patients. Source: Dr. Nathan INDEX OF ADVERTISERS The Chatham Institute/Wyeth Pharmaceuticals Inc. CME 6 Ethicon Endo-Surgery, Inc. Echelon 45 General Scientific Corporation SurgiCam I-Flow Corporation ON-Q Painbuster KCI InfoV.A.C. Wyeth Pharmaceuticals Inc. TYGACIL 3 7 9 5 15-16 TYGACIL® (tigecycline) Brief Summary See package insert for full Prescribing Information. For further product information and current package insert, please visit www.wyeth.com or call our medical communications department toll-free at 1-800-934-5556. CONTRAINDICATIONS TYGACIL is contraindicated for use in patients who have known hypersensitivity to tigecycline. WARNINGS Anaphylaxis/anaphylactoid reactions have been reported with nearly all antibacterial agents, including tigecycline, and may be life-threatening. Glycylcycline class antibiotics are structurally similar to tetracycline class antibiotics and may have similar adverse effects. TYGACIL should be administered with caution in patients with known hypersensitivity to tetracycline class antibiotics. TYGACIL may cause fetal harm when administered to a pregnant woman. If the patient becomes pregnant while taking tigecycline, the patient should be apprised of the potential hazard to the fetus. Results of animal studies indicate that tigecycline crosses the placenta and is found in fetal tissues. Decreased fetal weights in rats and rabbits (with associated delays in ossification) and fetal loss in rabbits have been observed with tigecycline. (See PRECAUTIONS, Pregnancy.) The use of TYGACIL during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). Results of studies in rats with TYGACIL have shown bone discoloration. TYGACIL should not be used during tooth development unless other drugs are not likely to be effective or are contraindicated. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including TYGACIL, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. PRECAUTIONS General Caution should be exercised when considering TYGACIL monotherapy in patients with complicated intra-abdominal infections (cIAI) secondary to clinically apparent intestinal perforation. (See ADVERSE REACTIONS.) In Phase 3 cIAI studies (n=1642), 6 patients treated with TYGACIL and 2 patients treated with imipenem/cilastatin presented with intestinal perforations and developed sepsis/septic shock. The 6 patients treated with TYGACIL had higher APACHE II scores (median = 13) vs the 2 patients treated with imipenem/cilastatin (APACHE II scores = 4 and 6). Due to differences in baseline APACHE II scores between treatment groups and small overall numbers, the relationship of this outcome to treatment cannot be established. Glycylcycline class antibiotics are structurally similar to tetracycline class antibiotics and may have similar adverse effects. Such effects may include: photosensitivity, pseudotumor cerebri, and anti-anabolic action (which has led to increased BUN, azotemia, acidosis, and hyperphosphatemia). As with tetracyclines, pancreatitis has been reported with the use of TYGACIL. The safety and efficacy of TYGACIL in patients with hospital acquired pneumonia have not been established. In a study of patients with hospital acquired pneumonia, patients were randomized to receive TYGACIL (100 mg initially, then 50 mg every 12 hours) or a comparator. In addition, patients were allowed to receive specified adjunctive therapies. The sub-group of patients with ventilator-associated pneumonia who received TYGACIL had lower cure rates (47.9% versus 70.1% for the clinically evaluable population) and greater mortality (25/131 [19.1%] versus 15/122 [12.3%]) than the comparator. As with other antibacterial drugs, use of TYGACIL may result in overgrowth of non-susceptible organisms, including fungi. Patients should be carefully monitored during therapy. If superinfection occurs, appropriate measures should be taken. Prescribing TYGACIL in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. Information for Patients Patients should be counseled that antibacterial drugs including TYGACIL should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When TYGACIL is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by TYGACIL or other antibacterial drugs in the future. Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible. Drug Interactions Prothrombin time or other suitable anticoagulation test should be monitored if tigecycline is administered with warfarin. (See CLINICAL PHARMACOLOGY, Drug-drug Interactions in full prescribing information.) Concurrent use of antibacterial drugs with oral contraceptives may render oral contraceptives less effective. Drug/Laboratory Test Interactions There are no reported drug-laboratory test interactions. Carcinogenesis, Mutagenesis, Impairment of Fertility Lifetime studies in animals have not been performed to evaluate the carcinogen http://www.wyeth.com http://www.wyeth.com

Table of Contents Feed for the Digital Edition of Surgery News - November 2007

Surgery News - November 2007 Contents Black Patients Fare Worse Than Whites After Liver Surgery Survey Suggests Need For Acute Care Surgery New Law Bolsters FDA Funding, Authority Working Together Oncology: Marginal Evidence? Trauma: Screening Scrutinized News From the College: Healy Takes Helm

Surgery News - November 2007

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