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Does it make sense to treat children for conditions, such as high cholesterol, type 2 diabetes and hypertension, with drugs that have only been approved for adults? If the potential benefit to the child is outweighed by the risk of harm or adverse events, then it makes sense, experts say.
Does It Make Sense To Treat children for conditions, such as high cholesterol, type 2 diabetes and hypertension, with drugs that have only been approved for adults? If the potential benefit to the child is outweighed by the risk of harm or adverse events, then it makes sense, experts say.
"This determination would certainly have to be made on a case-by-case basis," says Mesfin Tegenu, president of PerformRx, a pharmacy benefits manager (PBM) located in Philadelphia.
According to a 2007 study conducted by IMS in 2007, more than 40% of children between the ages of six and 14 take prescription medications, including those for asthma, allergy, ADHD, type I diabetes and other conditions.
Lon Castle, MD, senior director, Department of Medical and Analytical Affairs for Medco, is more concerned about the growing trend toward adult diseases in children, than the use of medications to treat those conditions.
"Many drugs tested for adults are appropriate for children, so I don't think the health of children is jeopardized by these drugs," he says, "but I am concerned that our lifestyle is creating conditions children shouldn't face until at least their 40s. This extra need for healthcare will overburden our system."
"I don't like to see an increased need for intervention, but realize that there is an opportunity to change lifestyle behavior delaying or mitigating complications from obesity," he says. "On the other hand, I am concerned that medications will be used instead of diet and exercise."
According to Michael S. Jacobs, national clinical practice leader with Buck Consultants in Atlanta, treating children with drugs designed for adult diseases has the potential to send a message that unhealthy behavior is acceptable because the responsibility to treat the problem lies with other sources or the problem will be solved by science at the expense of employers or the government.
"The drugs have a tendency to work to resolve an immediate health condition," Jacobs continues, "but they do not work to solve the underlying problems-an unhealthy diet and lack of exercise. So lowering the cholesterol in a child, for example, is not the solution, but might buy time to get the child to solve the problem."
According the General Accountability Office (GAO) in a paper released in 2007, only about one-third of the drugs that are prescribed for children have been studied and labeled for pediatric use.
"The use of medications in the pediatric population that have been approved for use in adults for the treatment of 'adult diseases' has been a topic of controversy for decades," Tegenu says. "It has been a rather hot topic for the past 10 years with a significant number of legislative and FDA initiatives enacted to provide more information on the effects of these drugs in infants, adolescents, and teens."
One of the concerns is that medications prescribed for adults at certain dosages do not always translate to children, who are physiologically different.