Navigation Links
Doctors Unaware If Pediatric Dosages Are Safe

Drugs prescribed to children are not checked properly for their safety and efficacy, says a new study by Duke University Medical Center researchers. // The drugs that are being indiscriminately prescribed include antidepressants, antiseizure medications and sedatives.

The researchers analyzed drugs covered by a "congressionally mandated program known as "pediatric exclusivity," through which the Food and Drug Administration (FDA) may extend the period of time that a company holds exclusive marketing rights for a drug -- thereby delaying the entry of competing generic drugs -- if the manufacturer conducts FDA-requested trials on its use in children.

The researchers looked at how often the results of such studies were published in peer-reviewed scientific journals, often cited as among the most effective ways to communicate information to the medical community. Fewer than half of the pediatric exclusivity studies were published, the researchers found, and the results were less likely to be published if the drug was deemed unsafe or ineffective in children.

"Because children have different physiologies than adults, they often absorb drugs differently or experience different side effects," said the study's lead investigator, Daniel K. Benjamin, 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. "Much of pediatric drug use is done 'off label,' meaning that 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 how much information about use of the drug in the pediatric population is known."

The FDA designed the pediatric exclusivity program to increase knowledge about how children may react differently to commonly used drugs that have not been previously studied in the pediatric population. Based on their study the Duke res earchers suggest that the results of these pediatric exclusivity studies are not being widely disseminated outside mandated changes to label information.

The team reports its findings in the Sept. 13, 2006 issue of the Journal of the American Medical Association. There was no grant funding for this study.

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, among others. According to Benjamin, the studies resulted in key labeling changes -- defined as a significant finding related to dosing, safety or efficacy that is different from adults -- on 100 drugs. But of those studies, only 37 were published in peer-reviewed journals, the researchers found.

Studies could result in more than one key labeling change. In cases 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, the study found.

The FDA publishes label change information on its Web site (http://www.fda.gov/cder/pediatric/labelchange.htm), but users must know what they are looking for and where to look in order to find it, Benjamin said.

"The pediatric exclusivity program has been extremely successful in bringing about labeling changes where indicated, but additional efforts are needed to better inform the medical community about these changes and the studies behind them," he said. "Not having this information can be detrimental to patient care."

Examples of drugs that were tested through the pediatric exclusivity program and received labeling changes include more than a dozen products -- including antiseizure medications and some psychiatric drug s -- that required dosing adjustments for use in children, according to Benjamin.

In another study, the drug Propofol, while effective when used to induce or maintain anesthesia in critically ill patients, proved to have an increased mortality rate among pediatric patients when used as a sedative, compared with patients who received standard sedative agents. As a result of this study, a labeling change was made.

The researchers found that if a study resulted in a "positive" labeling change, meaning a drug's safety and effectiveness in children was established, it was more likely to be published. Fifty-four percent of such studies were published, compared with 36 percent of studies that resulted in a negative labeling change, which might include a finding that the drug showed no meaningful clinical effect in children or that it was associated with a worse outcome than the comparison therapy.

Though the pediatric exclusivity program itself has been a useful tool in making drugs safer for children through labeling changes, more can be done to make sure this information is getting into the right hands, said Benjamin.

"Physicians are used to using peer-reviewed journals as a source for the latest medical information, so it makes sense to get this information in there," he said.

Source-Eurekalert
RAS
'"/>




Related medicine news :

1. Cancer Doctors Okays Controversial Prostate Therapy
2. Doctors needed urgently in Gujarat
3. Doctors operate upon patients in candlelight- latest from the quake scene
4. Doctors at risk- the ugly side of the noble profession
5. Doctors advice early anemia tests
6. Emphasis to ban Drugs ads by Doctors
7. Doctors not to accept gifts from drug companies
8. Gene testing kit specific for Doctors
9. Doctors warned of fluoride toxicity
10. Doctors decisions are affected by fear of lawsuits- says a study
11. Bihar High Court Intervenes To End Doctors Strike
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:6/26/2016)... , ... June 26, 2016 , ... PawPaws brand ... new product that was developed to enhance the health of felines. The formula is ... The two main herbs in the PawPaws Cat Kidney Support Supplement Soft ...
(Date:6/25/2016)... Austin, TX (PRWEB) , ... June 25, 2016 , ... ... Fellow of the American College of Mohs Surgery and to Dr. Russell Peckham for ... popular and highly effective treatment for skin cancer. The selective fellowship in Mohs Micrographic ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern Californian, Dr. ... his M.D from the David Geffen School of Medicine at UCLA. He trained in ... to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he ...
(Date:6/24/2016)... ... 2016 , ... A recent article published June 14 on E ... goes on to state that individuals are now more comfortable seeking to undergo not ... as calf and cheek reduction. The Los Angeles area medical group, Beverly Hills Physicians ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... Sessions in Dallas that it will receive two significant new grants to support ... as PHA marked its 25th anniversary by recognizing patients, medical professionals and scientists ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... Va. , June 24, 2016 The ... set of recommendations that would allow biopharmaceutical ... (HCEI) with entities that make formulary and coverage decisions, ... the "value" of new medicines. The recommendations ... does not appear on the drug label, a prohibition ...
(Date:6/24/2016)... , June 24, 2016  American Respiratory Labs (ARL), a ... now able to perform sophisticated lung assessments in patients, homes, thanks ... Inc. Patients are no longer limited to having ... PRO ® , ARL patients like Jeanne R. of ... the comfort of her own home. ...
(Date:6/24/2016)... -- According to a new market research ... Safety Pen Needles), Needle Length (4mm, 5mm, 6mm, 8mm, ... Purchase (Retail, Non-Retail) - Trends & Global Forecasts to ... for the forecast period of 2016 to 2021. This ... 2021 from USD 1.65 Billion in 2016, growing at ...
Breaking Medicine Technology: