Studies on effects of drugs on children often not published

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Studies on effects of drugs on children often not published

http://www.news-medical.net/?id=20126

According to a new study by researchers at Duke University Medical

Center, many of the drugs that are prescribed for children may not in

fact be either safe or effective for pediatric use and could require

different doses than is recommended. The researchers say drugs such

as antidepressants, anti seizure medications and sedatives are

covered by a congressionally mandated program titled " pediatric

exclusivity " .

This means that the Food and Drug Administration (FDA) may extend the

period of time that a company holds exclusive marketing rights for a

drug if the manufacturer conducts FDA-requested trials on its use in

children.

This in essence delays the approval of equivalent generic drugs which

might compete with the product.

The researchers examined how often the results of such studies were

published in peer-reviewed scientific journals, which is considered

to be the most effective ways to communicate information to the

medical community.

They found that less than half of the pediatric exclusivity studies

were published, and the likelihood of them being published was far

less if the results demonstrated the drug was unsafe or ineffective

in children.

K. , M.D., Ph.D., a pediatrician at the Duke Clinical

Research Institute who also holds an appointment at the FDA's Office

of Pediatric Therapeutics was the study's lead investigator, and he

says because children have different physiologies than adults, they

often absorb drugs differently or experience different side effects.

Therefore says , much of pediatric drug use is done 'off

label', and this means children are often treated based on what has

been shown to be effective in older patients, and the results can be

beneficial, harmful or not effective, depending on the available

information about use of the drug in children.

The pediatric exclusivity program was originally designed by the FDA

to improve knowledge of how children react differently to commonly

used drugs that have not been previously studied in the pediatric

population.

The Duke researchers suggest that the results of these pediatric

exclusivity studies are not widely disseminated beyond mandated

changes to labels.

According to between 1998 and 2004, manufacturers conducted

253 studies through the pediatric exclusivity program on drugs

indicated for the treatment of conditions such as pain, diabetes,

gastroesophageal reflux, seizures and psychiatric disorders.

Important labeling changes such as significant information related to

dosing, safety or efficacy that differs from adults were placed on

100 drugs, yet only 37 of the studies were published in peer-reviewed

journals.

The research found that such studies could result in more than one

key labeling change; where there was a dosing change, only 49 percent

of studies were published in peer-reviewed journals; when there was a

change to safety information, only 43 percent were published, and

when the drug was found to be ineffective in children, only 38

percent were published.

Although the FDA publishes label change information on its web site,

says people must know what they are looking for and where to

look, in order to find it.

He concludes that though the pediatric exclusivity program has been

successful in bringing about labeling changes where indicated, more

efforts are needed to better inform the medical community about these

changes and the studies behind them.

The study is published in the current issue of the Journal of the

American Medical Association.