Rocephine And The Neonate

Childhood Bacterial Meningitis Brings Hefty Late Sequelae

VAIL, COLO. – Half of all childhood bacterial meningitis survivors have sequelae 5 years or more afterward, according to a systematic literature review.

Intellectual and/or behavioral deficits accounted for 78% of the long-term sequelae. These are lingering aftereffects that impose academic and behavioral limitations, not the very common minor neurologic deficits that often resolve soon after discharge, Dr. Ann-Christine Nyquist noted at a conference on pediatric infectious diseases sponsored by Children’s Hospital Colorado.

She said she presented highlights of a literature analysis conducted by Dr. Aruna Chandran and coworkers at Johns Hopkins University, Baltimore, because she considers this to be the first good-quality, comprehensive data on the long-term sequelae of childhood bacterial meningitis.

Most prior studies have focused on sequelae present in the first months following a childhood episode of bacterial meningitis; the Johns Hopkins analysis was restricted to studies featuring a minimum follow-up of 5 years. It provides a far more complete picture of the disease’s underappreciated impact, noted Dr. Nyquist, a pediatric infectious diseases specialist at the University of Colorado at Denver.

The analysis included 1,433 children who survived an episode of bacterial meningitis, 49% of whom had one or more long-term sequelae. Seventy-eight percent of the 1,012 recorded long-term sequelae were behavioral and/or intellectual deficits. Specifically, 45% of all long-term sequelae were categorized as low intelligence quotient/cognitive impairment, 7.6% as behavioral deficits, and 2.4% as attention-deficit/hyperactivity disorder.

Gross neurologic deficits accounted for 14.3% of long-term sequelae. Another 6.7% consisted of hearing deficits ( Pediatr. Infect. Dis. J. 2011;30:3-6 ).

These data underscore the importance of prompt diagnosis and effective treatment of pediatric bacterial meningitis, Dr. Nyquist emphasized.

FDA Safety Changes: Advicor, Rocephin, Tindamax » Cooper ...

This activity is part of an ongoing CME/CE initiative to provide information on label changes reported by the FDA. Activities of this nature will be posted on Medscape on a weekly basis.

August 16, 2007 — The US Food and Drug Administration (FDA) has approved safety labeling revisions to advise of drug interactions that increase the risk for myopathy/rhabdomyolysis associated with the lovastatin component of niacin extended-release/lovastatin tablets, the risks associated with concomitant use of calcium or calcium-containing solutions/products and ceftriaxone sodium manufacturer injection, drug interactions with tinidazole tablets, and the risk for Candida vaginitis in patients with bacterial vaginosis receiving a course of treatment with tinidazole.

Lovastatin Component of Advicor Linked to Drug Interactions That Increase Risk for Myopathy

On April 6, the FDA approved safety labeling revisions for niacin extended-release/lovastatin tablets ( Advicor; KOS Pharmaceuticals, Inc) to advise of certain drug interactions that increase the risk for myopathy/rhabdomyolysis associated with the lovastatin component.

As with other 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors, lovastatin may cause myopathy that presents as muscle pain, tenderness, or weakness with creatine kinase levels greater than 10 times the upper limit of normal. Myopathy may also take the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and rare fatalities have occurred.

Because lovastatin is metabolized by the cytochrome P-450 isoform 3A4 (CYP 3A4) enzyme, concomitant administration of potent CYP 3A4 inhibitors results in elevated 3-hydroxy-3-methylglutaryl coenzyme A plasma activity levels and may increase the risk for myopathy. According to the FDA, serious skeletal muscle disorders (eg, rhabdomyolysis) have been reported during concomitant use of these drugs.

Drugs considered to be potent CYP 3A4 inhibitors include cyclosporine, itraconazole, ketoconazole, and other antifungal azoles; the macrolide antibiotics erythromycin and clarithromycin; the ketolide antibiotic telithromycin; HIV protease inhibitors; and nefazodone. Large quantities of grapefruit juice (> 1 quart daily) may also exert this effect.

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