News in brief - Jan. 23, 2006

Hep A, meningitis shots needed for more children, adolescents - ADHD patch receives FDA "approvable letter" - Superbugs a growing problem - Painkiller study looks at risk management

Hep A, meningitis shots needed for more children, adolescents

The hepatitis A shot should be given to all children between the ages of 12 months and 23 months, regardless of the disease's prevalence where they reside. And the fourth dose of diphtheria, tetanus and pertussis, DTaP, may be given as early as 12 months if the third dose was given at least six months earlier and it seems unlikely that the child will be returning to get the shot at 15 months when it is preferred, according to the recommended childhood and adolescent immunization schedule published by the Centers for Disease Control and Prevention, the American Academy of Family Physicians and the American Academy of Pediatrics this month.

The schedule is revised annually. New recommendations also were made for pre-teens and adolescents. This age group now should receive the meningococcal conjugate vaccine along with a single dose of the combination shot of tetanus, diphtheria and pertussis.

Public health officials hope these new recommendations will further reduce the burden of these diseases. "We can now protect children and adolescents from more diseases than at any time in our history," said Anne Schuchat, MD, director of the CDC National Immunization Program.

Hepatitis A shots were previously recommended only for children in high-prevalence areas. The age requirement for the four dose of DTaP is being relaxed because of increasing recognition that too many children are missing doses. The adolescent recommendations incorporate into the schedule new vaccines approved by the Food and Drug Administration within the past year.

ADHD patch receives FDA "approvable letter"

A skin patch that provides medication to treat attention-deficit/hyperactivity disorder in children ages six to 12 may be approved by the Food and Drug Administration, according to a statement issued last month by Noven Pharmaceuticals and Shire PLC, the companies developing the product.

The FDA issued an "approvable letter" for methylphenidate transdermal system (Daytrana), recommending label revisions and post-marketing surveillance as necessary to gain the agency's approval.

"Noven and Shire will be working with the FDA as necessary to address the remaining issues and to advance the [new drug application] toward final approval," said Noven President and CEO Robert C. Strauss.

Previous applications for approval had been declined because of problems with insomnia and anorexia associated with wearing the patch for 12 hours. Fewer adverse events have been associated with shorter wearing times, and one of the agency's advisory panels recommended last month that the label encourage its use primarily by children who had problems taking the medication's pill form.

Superbugs a growing problem

About 2 million Americans carry a strain of drug-resistant bacteria in their noses, says a study in the Jan. 15 Journal of Infectious Diseases.

The Staphylococcus aureus bacteria found lodged in nasal passages included methicillin-resistant S. aureus, which can cause serious infections that are difficult to treat. MRSA was once primarily a problem in hospitals, but it is now a growing problem in communities around the country and some blame the inappropriate use of antibiotics.

Samples were collected from nearly 10,000 participants in the 2001-02 National Health and Nutrition Examination Survey conducted by the Center for Disease Control and Prevention's National Center for Health Statistics. The participants are considered a representative sample of the nation's population.

Nearly one-third of the participants were found to be colonized with staph, with the highest prevalence among males and children between 6 and 11 years old. Traditional MRSA was most frequently found among women and in people older than 60. The MRSA strains most common in communities were more likely to be found in young black individuals.

"Interestingly, carriage of certain strains do seem to vary by sociodemographics, especially age and race," said Matthew J. Kuehnert, MD, a CDC epidemiologist. "We need to learn more in order to allow design of new, more effective interventions."

Painkiller study looks at risk management

Genetic makeup contributed about 30% to the variability with which individuals responded to the painkillers Vioxx and Celebrex, according to a recent study. Both of the COX-2 inhibitors now have been withdrawn from the market because of the risk they carried for heart attacks and stroke. The analysis of how people vary in their response to the drugs was published in the January issue of Gastroenterology.

Researchers at the University of Pennsylvania examined the variability, both within and between subjects, in response to rofecoxib, or Vioxx, and celecoxib, or Celebrex, in a randomized, double-blind, placebo-controlled trial.

Fifty healthy volunteers between ages 21 and 43 received a single dose of placebo, celecoxib and rofecoxib in random order. This was done to allow researchers a direct comparison of the responses to the drugs within the same subjects.

Approximately 30% of the variability found in patients was attributable to differences between individuals, suggesting the contribution of genetics to a variety of biomarkers of drug response. The study also illustrated that even healthy individuals without a recognized risk of disease respond quite differently to the drugs.

The authors said they hoped that their work would provide an impetus for the development of a science-based approach to risk management. Exploitation of variability in response can lead to tests that identify patients most likely to benefit or have harmful side effects caused by these drugs, they said.