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When doctors can't rely on clinical trial reports, the very foundation of pharmaceutical medicine is destroyed, " said Dr. Ramn Castellblanch, a professor of Health Education at San Francisco State University. "Medicine, not marketing, must drive clinical trial design and reporting." FDA enforcement is ineffective. The FDA's letters did not deter future deceptive advertising. 28 companies-- approximately 1 3 of the total receiving FDA enforcement letters --received more than one letter declaring their ads false or misleading in the five years examined. In fact, these 28 companies accounted for two-thirds of all the letters received. While some of these letters identified different types of deceptive advertising problems relating to different drugs sold by the company, nearly all of these companies received more than one letter addressing the same problem.
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VASOOCCLUSIVE DISEASE underlies chronic organ dysfunction and acute, painful crises that typify sickle cell disease 5, 15, 21 ; . Such vasoocclusive disease, recently highlighted in a transgenic knockout sickle mouse expressing exclusively human sickle hemoglobin 6, 28, 36 ; , involves numerous mechanisms: sickling of red blood cells, enhanced endothelial adhesiveness of red
Cant differences between the two cephalosporins. Notwithstanding pharmacokinetic differences, the results of this study indicate that cephradine and cefazolin are comparable in therapeutic effectiveness. Toxicity was not a problem with either drug.
LITERATURE CITED 1. Bauernfeind, A. 1983. Susceptibility of gram positive aerobic cocci to the new cephalosporin HR 810. Eur. J. Clin. Microbiol. 2: 354-355. 2. Cullman, W., W. Opferkuch, and M. Stieglitz. 1983. Relation between 1-lactamase production and antimicrobial activity: comparison of a new compound HR 810 with cefotaxime. Eur. J. Clin. Microbiol. 2: 350-352. 3. Cullman, W., W. Opferkuch, M. Steiglitz, and U. Werkmeister. 1982. A comparison of the antibacterial activities of N-formimidoyl thienamycin MK0787 ; with those of other recently developed 3-lactam derivatives. Antimicrob. Agents Chemother. 22: 302-307. 4. Kurtz, T. 0., D. J. Winston, J. A. Hindler, L. S. Young, W. L. Hewitt, and W. J. Martin. 1981. Comparative in vitro activity of moxalactam, cefotaxime, cefoperazone, piperacillin, and aminoglycosides against gram-negative bacilli. Antimicrob. Agents Chemother. 18: 645-648. 5. Lea, A. S., A. W. Sudan, B. A. Wood, and L. 0. Gentry. 1982. Randomized comparative study of moxalactam and cefazolin in the treatment of acute urinary tract infections in adults. Antimicrob. Agents Chemother. 22: 32-35. 6. Mackha, K., and I. Braveny. 1983. In vitro activity of HR 810, a new broad spectrum cephalosporin. Eur. J. Clin. Microbiol. 2: 345-349. 7. National Committee for Clinical Laboratory Standards. 1983. Tentative standard M7-T. Standard method for dilution antimicrobial susceptibility tests for bacteria which grow aerobicaily. National Committee for Clinical Laboratory Standards, Villanova, Pa. 8. Neu, H. C. 1982. The new 13-lactamase stable cephalosporins. Ann. Intern. Med. 97: 408-419. 9. Neu, H. C. 1983. Adverse effects of new cephalosporins. Ann. Intern. Med. 98: 415-416. 10. Pakter, R. L., T. R. Russell, C. H. Mielke, and D. West. 1982. Coagulopathy associated with the use of moxalactam. J. Am. Med. Assoc. 248: 1100. 11. Platt, R., S. L. Erhlich, J. Afarian, T. F. O'Brien, J. E. Pennington, and E. H. Kass. 1981. Moxalactam therapy of infections caused by cephalothin-resistant bacteria: influence of serum inhibitory activity on clinical response and acquisition of antibiotic resistance during therapy. Antimicrob. Agents Chemother. 20: 351-355. 12. Preheim, L. C., R. G. Penn, C. C. Sanders, R. V. Goering, and D. K. Giger. 1982. Emergence of resistance to P-lactam and aminoglycoside antibiotics during moxalactam therapy of Pseiudomonas aeruginosa infections. Antimicrob. Agents Chemother. 22: 1037-1041. 13. Seibert, G N. Klesel, M. Linbert, E. Schrinner, K. Seeger, I. Winkler, R. Lattrel, J. Blumbach, W. Durckheimer, K. Fleischmann, R. Kirrstetter, B. C. Ross, K. H. Scheunemann, W, Schwab, and M. Wieduwilt. 1983. HR 810, a new parehteral cephalosporin with a broad antibacterial spectrum. Arzneim. Forsch. 33: 1084-1086. 14. Seibert, G., M. Limnbert, I. Winkler, and T. Dick. 1983. The antibacterial activity in vitro and P-lactamase stability of the new cephalosporin HR 810 in comparison with five other cephalosporins and two arinoglycosides. Infection 11: 275-279. 15. Tolxdorff-Neutzling, R. M., and B. Wiedeimann. 1983. HR 810, a cephalosporin with low affinity for Enterobacter cloac-ae betalactamase. Eur. J. Clin. Microbiol. 2: 352-353. 16. Weitekamp, M. R., and R. C. Aber. 1983. Prolonged bleeding times and bleeding diathesis associated with moxalactam administration. J. Am. Med. Assoc. 249: 69-71 and cefprozil.
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Table III. Total number and percentage of centromere-negative CN ; and centromere-positive CN ; micronuclei MN ; Group Patients P1 P2 P3 Mean in patients Controls C1 T1 C2 Mean in controls T1.
We will compare our current conclusions with the recent APA Practice Guideline for the Treatment of Patients With Bipolar Disorder 50 ; on two key points. First, there is no strong reason to avoid antidepressants for patients with bipolar depression. This is at odds with the recommendation to use lithium or lamotrigine as a first-line of treatment for bipolar depression. For patients already taking a mood stabilizer, we advise adding an antidepressant as a first-line treatment. For patients not taking a mood stabilizer but with a history of mania, the current consensus is to use antidepressants in combination with an antimanic agent or a mood stabilizer 51 ; . Much of the data reviewed here reflect that practice. Whether nontricyclic antidepressants can safely be used as monotherapy, especially in bipolar II depression, is not excluded by the existing data. Current APA guidelines suggest that the rate of switching is less of a worry in the acute treatment of bipolar II than in bipolar I depression and that, therefore, antidepressants can be added earlier in treatment. This is neither supported nor contradicted by the evidence from randomized, controlled trials. Consensus views are heavily influenced by clinical experience and formal audit, not randomized, controlled trials. Second, it may be prudent to use an SSRI or an MAOI rather than a tricyclic antidepressant or bupropion as a first-line treatment. This also differs from the guidelines, which specifically recommend paroxetine and bupropion as antidepressants. We see only very limited evidence for bupropion and only limited evidence for a special place for paroxetine among the SSRIs. To prefer either is to move beyond the evidence. Obviously, our conclusions are based on the results of randomized, controlled trials only, and we have not considered evidence from naturalistic and other nonrandomized studies. However, there is no strong signal that antidepressants other than tricyclic antidepressants ; cause mania or even rapid cycling from these studies either 52, 53 ; . On the basis of current evidence, we believe that it is overcautious and potentially not in the best interest of patients to discourage the use of antidepressants for bipolar depression. We appreciate that the existing APA guidelines do recommend the use of specific antidepressants for severe depression. However, in practice, we have seen cases in which patients have not been treated with antidepressants and have been left chronically and significantly depressed for very long periods of time. This is almost certainly one consequence of an emphasis on the first-line use of mood stabilizers such as lithium and valproate for bipolar depression, despite the inadequate evidence that they actually work and ceftriaxone.
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Eligibility Criteria - Age 3 mos. Elective surgery. No significant comorbidities. Timeline Unit Dept. Date Assessment Monitoring Cardiac Resp Pulm. Fluid status Diagnostics Weight, Height, vital signs Assess breath sounds, 02 sat. CXR-PA & lateral EKG, H&P CBC diff, renal panel, UA, T&C, + - HCG + - echo if none 4-6 wks prior Vital signs q 15"x2h, per routine CR monitor, atrial lines, A-line 3breath sounds, 02 sat, CT drng Measure I&O. Foley. NG output. On arrival in CICU: CXR, EKG, CBC, PT PTT, renal panel, Glu, Mg, Ca + , ABG. CBC, K + , Ca + , Glu, lactate, ABG q 4hrs Antibiotic Cefazolin ; G11[B] ; Dopamine + - Milrinone Morphine, midazolam IV maintenance fluids Acetaminophen Bidirectional Glenn Ventilator wean per protocol. NPO NG low continuous suction ; Vital signs per routine CR monitor, RA LA, A-line 3breath sounds, 02 sat, CT drng Measure I & O. CXR in a.m. Labs: CBC, renal panel, Glu bid Ca + & ABG in and q 4 hrs Pre-op * SDS Day of Surgery * OR CICU Post-op Day #1 CICU.
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including cefazolin , and may range in severity from mild to life -threatening and celestone.
We were not able to find any similar randomized study analyzing in a systematic fashion the effect of an appropriate prophylactic regimen against enterococci in the development of SSI after elective cholecystectomy. A study that assessed cefazolin sodium vs piperacillin in open cholecystectomy found a better in vitro activity of piperacillin in comparison with cefazolin against bacterial isolates recovered from bile cultures.27 However, only 5 of 34 isolates from biliary cultures were identified as enterococci, and only 1 mixed infection with Enterococcus species and 3 other gram-negative pathogens were observed in the piperacillin group.27 One other study of 80 patients found equal efficacy between ampicillin-sulbactam and cefoxitin sodium as prophylaxis in biliary surgery.28 Our results contradict those of a small study that compared the use of 3 instead of 1 perioperative doses of amoxicillin clavulanate potassium a combination similar to the one used in the present study ; to 1 dose of ceftibuten and found more infections in the group that received amoxicillin clavulanate potassium.29 Another study that looked at 205 patients with upper abdominal surgery including biliary operations ; found no statistical differences in wound infections between amoxicillinclavulanate potassium and cefotaxime sodium, a third-generation cephalosporin. Nevertheless, this study may have been underpowered since fewer wound infections occurred in the amoxicillin clavulanate potassium group 4.5% vs 7.4% ; .30 The discovery of bactibilia in the present study was associated with subsequent development of SSI. When SSI occurred, it was caused mainly by exactly the same pathogen s ; found in intraoperative cultures. This is an issue for further research as our findings concur with previous findings10, 24 but exactly the opposite has been reported by others.31 Bactibilia was noted in a significant fraction of the patient population, mainly in those with a high risk for infection. A large percentage of patients had positive intraoperative culture results for Enterococcus species. This finding confirms the role of enterococci on biliary tract infections and provides further rationale for administering antimicrobials with antienterococcal activity in cholecystectomies.12-16, 32 Enterococcus faecium, a species that frequently exhibits resistance to -lactams, was very rarely isolated in our series and was not associated with any SSI. Contaminated bile can lead to pyogenic fluid collection if the gallbladder ruptures during the operation. Survival depends on the ultimate management of such a collection.33, 34 Perforation during gallbladder surgery is attributed to traction, grasping, dissection, and removal of the gallbladder and occurs in 10% to 15% of conventional and 15% to 25% of laparoscopic cholecystectomies.34, 35 The vast majority of SSI occurred in patients who experienced intraoperative gallbladder rupture. The rest occurred in high-risk patients with diabetes mellitus. This is likely not attributed to poor surgical technique, since it was exclusively noted in patients who received cefuroxime. On top of appropriate surgical technique, perioperative prophylactic antimicrobials seem to play a significant role, and if administered, fewer SSIs occur.11 In contrast, some authors support that the incidence of SSI is not altered by gallbladder rupture, if thereafter a clean surgical technique is applied.35, 36 Several stud REPRINTED ; ARCH SURG VOL 141, DEC 2006 1166.
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Cefazolin 2.25 mg ; was injected into the vitreous cavity of phakic, aphakic, and aphakic vitrectomized rabbits; inflamed eyes were compared to controls. Vitreous levels of cefazolin were determined at selected times from 2 to 48 hr, and the half-life was calculated. The effect of inflammation was to increase the half-life or to reduce the rate of elimination of cefazolin from the vitreous cavity. The drug was cleared substantially faster from aphakic vitrectomized eyes than from phakic or aphakic eyes. Vitreous levels of cefazolin were above the MIC for most common gram-positive organisms causing endophthalmitis in all study groups at 24 hr, but in only the phakic inflamed eyes and in the aphakic eyes with intact vitreous at 48 hr. Invest Ophthalmol Vis Sci 31: 502-505, 1990 and cellcept.
While cefazolin and cefmetazole slightly inhibited the growth of bacteria in nutrient broth, they showed hardly any bactericidal activity in normal serum and compromised host's serum.
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