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Lack of Child-Sized Drugs Putting Kids at Risk, WHO Says

Dec 7, 2007 | Parker Waichman LLP

Adult medications are not always appropriate for children, a situation that could be leading to serious injuries in kids from drug side effects. The World Health Organization (WHO), which this week reported that children are actually dying due to a lack of child-sized drugs tailored to their needs, launched a global campaign on Thursday to promote more research into child medicine.

More than half of the drugs currently used to treat children in the industrialized world have not yet been specifically tested on children, despite the known fact that children metabolize medications differently than adults.  Physicians often lack clear guidelines on the best drugs to use for children, also often guessing at prescribing the medications in correct dosages.  The problem is exacerbated in developing countries where drug prices are a challenge and where six million children die each year from treatable conditions, not to mention HIV/AIDS where the few pediatric therapies that do exist are generally at triple the cost of adult therapies.

In a bid to address the problem, the WHO has drawn up the first international List of Essential Medicines for Children which contains over 200 products deemed safe for children and that cover priority pediatric conditions.  Despite this, there is more to be done, for instance other priority medicines that have not either not been adapted for children's use or are not available when needed, according to the United Nations' Agency's Director of Medicines Policy and Standards, Dr. Hans Hogerzeil.  Medicines that need to be adapted to children's needs include many antibiotics, as well as asthma and pain drugs.  The WHO also wants more research and development of combination pills for HIV/AIDS, tuberculosis, and malaria and is building an Internet portal linking to clinical trials carried out in children; a Web site with the information is being launched in early 2008.

Testing medicines on children has always been challenging since good ethical practice requires informed consent from people participating in clinical trials; difficult to obtain in the case of children.  As a result, research-based drug companies have been wary of developing child-friendly medicines and generics companies have been slow to produce them at lower cost.  In an attempt to resolve the issue, both Europe and the United States now have special rules offering extended patent protection for drugs which have been tested on children.

To complicate matters, children- and adult-sized medications sometimes become confused as was the case with the newborn Quaid twins who were each given two massive overdoses of the blood thinner, Heparin, from vials that were 1,000 times stronger than what should have been prescribed, landing them in the neonatal intensive care unit.  Heparin is delivered in 10 unit vials for babies and vials up to 10,000 units for adults.  The twins were dosed from the adult vials, once on Sunday morning and again Sunday evening.  Pharmacy technicians stock the two Heparin types separately; however, a technician put the adult vials in the child-vial drawer.  Packaging and labeling is not different enough to visually differentiate dosing and has been a problem before:  three infants died in Indiana after being given adult doses; six other newborns received an overdose; and, in 2001, two patients were incorrectly dosed.


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