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Who Will Protect the Children from Prescription Drug Deaths?

By Rheingold Giuffra Ruffo Plotkin & Hellman LLP

We recently came across three articles highlighting how the youngest people of out country are subject to dangers from prescription drugs. Reuters reported on an FDA study about the extent to which prescription drug labels had instructions for use in children. Shockingly, 44% of drugs know to be given to children had no instructions for children. As reported in the Journal of the American Medical Association, older drugs were more likely to have labels while newer drugs (2002 through 2008) were less likely to have any dosage or side effects warnings for children.

Doctors are forced to experiment on what an appropriate dosage should be. One simple way to do this is just adjust the dosage down to the body weight. However, if the child has no response to the medication, it is impossible to tell if the the child was non-responsive to the medication or if the dosage was too small. Further, many children are too youg to be able to describe their ailment or a medication’s response.

This leads to the second article which discussed the findings of researhers at the respected Minnesota School of Public Health. Professors undertook to evaluate the pediatric drug studies, many of which are publically funded by your tax dollars running the National Institutes of Health. Their research founded less than have of pediatric studies were ever published. This means that important data will never be public.

All human drug studies can be registered with There are strict guidelines for choosing test subjects and then how the results are reported. Many parents and children believe they are acting in the public good by participating in drug trials, and it is shameful their participation is of no benefit. Dr. Scott Denne of the Indiana University School of Medicine has pointed to how the lack of reporting may be violating FDA and NIH guidelines, as well as study guidlelines issued by the American Academy of Pediatrics.

Of course, the scariest implication is that incomplete and non-reported studies revealed dangerous side effects which would be helpful to doctos who may be prescribing the drugs to children. Because shildren are healthier and there are ethical concerns in using them in studies, there is a lack of information. What there is, however, should be reported.

This brings us to a somewhat related issue which was reported on WebMD about child injuries and deaths caused by ingesting prescription drugs. Children like putting things in their mouths and many pills look like candy. Adults not careful with the handling and storage of medicine lead to sometimes tragic consequences.

Safe Kids Worldwide reports that annually in the United States that 60,000 kids 5 yearsold or younger are injured by improper dosage or accidental dosage. The drugs most often implicated in injuries and death from prescription or over-the-counter drugs are: pain relievers, sedatives, allergy medicine, antidepressants and sleeping pills.

The obvious answer is for adults and care gives to be vigilant with medication. In fact, it is a reasonable precaution to never allow children see the pills, pill bottles or adults taking the pills. Do not have loose pills on counters or in bags. Sadly, curosity kills more than cats

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