Will your ill child be a guinea pig?

Here’s a chilling statistic for you, straight out of a new study at the Primary Children’s Medical Center in Salt Lake City.

Over a five-month period, a shocking 96 percent of pediatric patients in intensive care received a drug off-label at least once. Among just the 13- to 17-year-olds, it was 100 percent.

That means that almost every single child in intensive care during that time was exposed to a drug that had not been adequately studied in children.

“Off-label” use means that a drug is being used when it is prescribed for a patient whose age is not on the label, when there is no data for use in someone of the patient’s age, or when the drug hasn’t been approved for the indication for which it’s being used.

To make matters worse, most of the drugs used in the study are off-patent. So, in other words, nobody’s chomping at the bit to perform the expensive studies necessary to prove that they’re safe or effective for children.

Meanwhile doctors are working more or less blind, playing a guessing game with dosages, and assuming that the known benefits and side effects for adults will be the same for children. This makes each kid in the ICU, essentially, his or her own personal clinical trial. As a parent you’re left feeling helpless as doctors are forced to experiment with what dose, if any, will help and not harm your child.

But if you ever find yourself in the terrible position of having a child in the ICU, remember that you don’t have to blindly trust that he’s receiving the best care. Instead, become an active participant in his care by asking about each drug and treatment he’s given. Don’t be afraid to specifically question if they have been tested and proven in children. And always ask about alternative options.

And finally, ask your representatives in Washington to lobby and vote for strengthening and expanding the FDA Safety and innovation Act, which requires pediatric studies for some drugs, but not nearly enough…only offering weak incentives for others.

Sources:
“Critically Ill Kids Often Get Drugs Off-Label,” Medpage Today (medpagetoday.com)

“Off-Label Medications Prescribed to Nearly All Pediatric Intensive Care Patients,” Science Daily (sciencedaily.com)