Pharmacology Watch
June 1, 2007 5 minutes read
Risk With Preventative Antibiotics Outweighs Benefit for Most
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Sweeping new changes have been made to the guidelines for prevention of endocarditis in patients undergoing dental procedures. The new recommendations dramatically reduce the indications for dental prophylaxis and reduce the number of patients who need preprocedure antibiotics. The guideline was issued by the American Heart Association in conjunction with the American Dental Association, Infectious Diseases Society of America, and the Pediatric Infectious Diseases Society and was published online April 19, 2007, in Circulation. The guidelines reflect evidence that the risk of taking preventative antibiotics outweighs the benefit for most patients. It is also been found that infectious endocarditis (IE) is more likely to result from frequent exposure to random bacteremias from activity such as flossing and brushing than from dental work. Specifically, the guidelines say that prophylactic antibiotics are no longer required for patients with mitral valve prolapse, rheumatic heart disease, bicuspid valve disease, calcified aortic stenosis, or congenital heart conditions such as ventricular septal defect, atrial septal defect, and hypertrophic cardiomyopathy. There are still patients who are at extremely high risk of IE who should continue to receive prophylactic antibiotics: patients with artificial heart valves, a history of infective endocarditis, congenital heart disease including unrepaired or incompletely repaired cyanotic congenital heart disease, including those with palliative shunts and conduits, those with a completely repaired congenital heart defect with prosthetic material during the first 6 months after the procedure, repaired congenital heart defect with residual defect at the site or adjacent to the site of a prosthetic patch or prosthetic device, or a cardiac transplant patient with a cardiac valvulopathy. Antibiotic prophylaxis is no longer recommended for any other form of congenital heart disease. Dosing regimens are essentially the same as previous recommendations and include oral amoxicillin 2 gm 30 to 60 minutes prior to procedure. Oral alternatives include cephalexin, clindamycin, azithromycin or clarithromycin. Parenteral regimens include ampicillin, cefazolin, ceftriaxone, and clindamycin. The guideline also no longer recommends antibiotics to prevent IE in patients undergoing genitourinary or gastrointestinal tract procedures (Circulation 2007, doi:10.1161/CIRCULATIONAHA.106. 183095). The full guideline is available at http://www.ada.org.
Gonococcal Infections, CDC's Updated Treatment
The CDC has issued updated treatment recommendations for gonococcal infections and associated conditions due to the high level of resistance of gonorrhea to fluoroquinolones. The agencies Gonococcal Isolate Surveillance Project demonstrates that fluoroquinolone-resistant gonorrhea is continuing to spread and is now widespread throughout United States. Therefore, fluoroquinolones such as ciprofloxacin, ofloxacin, or levofloxacin are no longer recommended. Current recommended regimens for gonococcal infections of the cervix, urethra, and rectum are ceftriaxone 125 mg IM and a single dose or cefixime 400 mg orally in a single dose plus treatment for chlamydia if chlamydial infection is not ruled out. Uncomplicated gonococcal infections of the pharynx should be treated with ceftriaxone 125 mg IM plus treatment for chlamydia, if chlamydial infection is not ruled out. Disseminated gonococcal infection should be treated with ceftriaxone 1 g IM or IV every 24 hours. Pelvic inflammatory disease may be treated with parenteral and oral therapy. Parenteral therapy regimens include cefotetan or cefoxitin plus doxycycline or clindamycin plus gentamicin. An alternative regimen is ampicillin/sulbactam plus oral doxycycline. Oral therapy can be considered in women with mild to moderate disease. With the loss of fluoroquinolones, cephalosporins are the mainstay of most regimens. For patients who are highly allergic to cephalosporins, spectinomycin may be considered although it is not generally available in this country. Another option is azithromycin, however, prescribing should be done in consultation with an infectious disease specialist due to concerns over emerging antimicrobial resistance to macrolides. The CDC's full recommendations are available online at www.cdc.gov.
Head Lice — Malathion First-Line Treatment
Malathion should be first-line treatment for children who have lice according to a new review in the journal Pediatrics. Head lice have become resistant to nearly all first-line treatments in United States including permethrin, which has been considered first-line treatment for years. Malathion, in the formulation containing isopropyl alcohol and terpineol, is safe and effective for lice and all existing points within the life cycle, and generally requires a single treatment, reducing the duration of infestation, and lost time from school and work. Concern about flammability seems to be over emphasized, as there have been no reported cases of bodily injury related to burns (Pediatrics 2007. 119:965-974).
Statins, May Cut the Risk of Cataracts
Statins, the cholesterol wonder drugs, have been associated with a number of other benefits including reduction of inflammation within the arteries, improved bone density, reduction in the risk of colon cancer, renoprotective effects, and reduction in the risk of Alzheimer's disease and other dementias. Now, a new study suggests that the drugs may also cut the risk of cataracts by 50%. Researchers from Australia reviewed the rate of cataract development in 3,654 elderly patients. After 10 years, after controlling for age, gender and others factors, the hazard ratio for any type of cataract in statin users was 0.52. In subgroups, there was a decreased risk of nuclear cataracts (HR = 0.66) and cortical cataracts (HR =0.76), but neither of these reached statistical significance. The authors conclude that there may be a protective influence of statins on cataracts and this needs to be further explored (Am J Ophthalmol 2007; 143:687-689).
FDA Actions
Sanofi Aventis has been approved to produce a vaccine to prevent bird flu in humans. The vaccine against the H5N1 virus will not be produced commercially, but will instead be stockpiled by the U.S. government for distribution in case of the outbreak. The FDA admits that the vaccine is not optimal, requiring a higher dose than normal flu vaccine, and 2 shots which must be given 28 days apart. But until other vaccines are developed, this vaccine will be used as the "interim measure."
The FDA is recommending updating black box warning regarding suicidality in young adults (under age 24) starting on antidepressants, calling for appropriate monitoring and close observation. The new recommendation should also include the statement that there was no increase in suicidality in adults over the age of 24, and a decrease in the risk in adults over the age of 64.
The FDA has approved generic versions of 2 of the most popular drugs of the last decade, Ambien (zolpidem) and Zoloft (sertraline). Zolpidem will be available in 5 mg and 10 mg immediate-release tablets. Thirteen manufactures have received approval to market the product. Sertraline is approved in the 25 mg, 50 mg and 100 mg strengths, and will be produced by Ranbaxy Laboratories.
The FDA has issued a warning about the health risks of dietary supplements touted as sexual enhancement products and treatments for erectile dysfunction that have been distributed under the trade names True Man and Energy Max. Both drugs have been sold throughout United States. Energy Max was found to contain an analogue of sildenafil, the active ingredient in Viagra, while True Man was found to contain an analogue of sildenafil and vardenafil, the active ingredient in Levitra. Both drugs can have serious interactions with nitrates.
This supplement was written by William T. Elliott, MD, FACP, Chair, Formulary Committee, Kaiser Permanente, California Division; Assistant Clinical Professor of Medicine, University of California-San Francisco. In order to reveal any potential bias in this publication, we disclose that Dr. Elliott reports no consultant, stockholder, speaker's bureau, research, or other financial relationships with companies having ties to this field of study. Questions and comments, call: (404) 262-5431. E-mail: [email protected].
Sweeping new changes have been made to the guidelines for prevention of endocarditis in patients undergoing dental procedures.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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