Drug Topics - November 19, 2007 - (Page H4)

4 HSE DRUG TOPICS NOVEMBER 19, 2007 www.drugtopics.com > > > Clinical Practice New injectable antibiotic welcomed with open arms Michael Dear, Pharm.D. he Centers for Disease Control & Prevention estimates that, in the United States alone, nearly two million people each year will acquire bacterial infections during their hospital stay, 90,000 of whom will die as a result. Seventy percent of those infections are caused by pathogens resistant to at least one drug. In the ongoing fight against life-threatening pathogens, and in particular drug-resistant ones, every weapon is an important one. That’s why the recent approval of Doribax (doripenem for injection, Johnson & Johnson), a broad-spectrum antibiotic, for the treatment of complicated intra-abdominal and complicated urinary tract infections is being met with open arms. Doripenem is a member of the carbapenem family of antibiotics. It exhibits bactericidal activity by inhibiting bacterial cell wall biosynthesis and has activity against gram-positive and gram-negative pathogens. It has shown effectiveness against Escherichia coli, Bacteroides fragilis, viridans group streptococci, Proteus species, Klebsiella pneumoniae, and Pseudomonas aeruginosa. It has also shown activity against anaerobic pathogens, with effectiveness similar to that of imipenem and meropenem. “This is a significant new drug for hospitalized patients with serious bacterial infections,” said Janet Woodcock, M.D., the Food & Drug Administration’s chief medical officer and acting director of the Center for Drug Evaluation & Research. This is due to the growing problem of bacterial resistance. P. aeruginosa, the leading pathogen in nosocomial pneumonia, in particular, has increasing multidrug resistance. T resistant strains grow and our list of antibiotics dwindle.” Doripenem is an important option for treating complicated infections, she said. “Resistant bacteria including P aeruginosa show low . rates of resistance to Doribax.” Rosner is referring to data from the 47th Annual Interscience Conference on Antimicrobial Agents & Chemotherapy (ICAAC). The data showed that overall clinical cure rates were 68.3% for doripenem and 64.8% for imipenem. For those patients with P aeruginosa infection, . doripenem demonstrated a 65% clinical cure rate compared with a 36% clinical cure rate seen with imipenem. Originally launched by Shionogi & Co. of Japan under the brand name Finibax in 2005, Doribax will be marketed by Ortho-McNeil. Doribax was granted fast-track status by the FDA in 2004 for the treatment of hospitalacquired pneumonia (HAP), including ventilator-associated pneumonia (VAP). In its approval, the FDA stated that doripenem has antimicrobial activity against gram-negative organisms resistant to other agents approved for the treatment of nosocomial pneumonia. Note these precautions The FDA demonstrated its concern for bacterial resistance in the product insert. Attached is a precaution to the indications that doripenem “should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.” In addition, patients Big problem for health care taking the antiepileptic medication “Drug resistance is one of the biggest problems facing valproic acid should have their levels checked while on health care today,” said Sara Rosner, Pharm.D., Valley doripenem. It has been shown that doripenem may reHospital, Ridgewood, N.J. “Every year we see the list of duce serum valproic acid to subtherapeutic levels. Common adverse reactions observed in the clinical trials of doripenem were headTIPS TO REMEMBER Doribax ache, nausea, diarrhea, rash, and phlebitis. Clostridium difficile-associated diarrhea has been associated Recommended dosing is 500 mg every with Doribax. Report if diarrhea occurs. eight hours by intravenous infusion adDoribax may lower valproic acid levels. Monitor levels closely. ministered over one hour for patients 18 years of age and older. Doripenem will Doribax’s recommended adult dose is 500 mg every eight hours. Dosage adjustment is required in patients with impaired renal function. be available in 500-mg vials of sterile doripenem powder. Doribax is rated Pregnancy Category B. THE AUTHOR is a writer based in Brooklyn, N.Y. http://www.drugtopics.com

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Drug Topics - November 19, 2007 Contents Latebreakers Letters Leukemia Patients Now Have More Options First-in-Class HIV Drug Boon to Patients at End of Tether 150 Years of American Pharmacy Pharmacy Schools Confront New Pressures From Pariah to Patient ACCP Releases Position Paper on Ethical Interactions New Injectable Antibiotic Welcomed with Open Arms NCCN Updates Head and Neck Cancer Guide Improved Phosphate Binder Approved for Dialysis Patients Considering Combination Concern Ensuring Seamless Care Bill Would Create Center for Comparative Effectiveness Hospital Improves Patient Safety with Automatic Drug Distribution System Infection Rates, Patient Stays Drop with New Drug Device How R.Ph.s Helped Three Hospitals Win Quality and Safety Awards A Pharmacist and Dog in Tow are Alzheimer’s Patients’ Best Friends More PBMs Agreeing to Pricing Transparency New Insulins in the Management of Diabetes New Products Advertisers Index Classified VIEWPOINT: Reflections on Pharmacy School After 30 Years

Drug Topics - November 19, 2007

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