Oops! Kids’ Meds Without FDA Approval?
A recently conducted poll of parents indicates that about 83% of them thought the last medications prescribed for their children had been approved for use as pediatric medications. The truth, however, is that not even a third of the medications routinely prescribed for children meet formal pediatric-specific approval from the US Food and Drug Administration (FDA).
Many of the medications prescribed for children have received formal FDA approval for use in adults but not for children. Some people think this is not a problem, since approval is approval. But kids’ bodies are different from adult bodies and they sometimes process medications differently.
Dosage parameters can be different between children and adults, making it tricky business when prescribing adult medications for children. Metabolism is different, too, which can influence how quickly a medication is processed once consumed. Side effects are always an important consideration when taking prescription medications, regardless of age, and they’re likely to affect children differently than they do adults.
Researchers at the University of Michigan’s C. S. Mott Children’s Hospital conducted the National Poll on Children’s Health, which found 77% of parents polled don’t want prescriptions written for their children unless they are for drugs approved for pediatric use by the FDA.
Other findings from the poll include:
94% of parents think it is their pediatrician’s responsibility to alert them to any non-approved prescriptions they recommend
Women are more likely to say they wanted only medications approved for pediatric use administered to their children
Less educated parents are more apt to want only FDA-approved pediatric medications
Matthew M. Davis, MD, MAPP, and director of the National Poll on Children’s Health, would like to see more research done with children but parents are understandably reluctant to enlist their own children for pharmaceutical studies. Nevertheless, the number of children taking prescription medications for chronic illnesses, such as attention deficit hyperactivity disorder (ADHD), asthma, and high blood pressure, is growing.
Esther Yoon, MD, affiliated with the University of Michigan’s Division of General Pediatrics’ Child Health Evaluation and Research Unit, says polls such as the National Poll on Children’s Health provides valuable information pertaining to parental expectation and points to the need for better communication between parent and pediatrician.
Yoon urges parents to act from a sense of empowerment, asking the doctor about FDA approval when medications are prescribed for their children. Physicians are urged to assume the role of educator when prescribing pediatric medications and be prepared to explain the pros and cons when suggesting medications that do not carry pediatric-specific labels.
The poll itself was conducted during December 2007 and January 2008 as a collaborative effort involving Knowledge Networks Inc. A random sampling of 2,131 adults aged 18 and over took the survey, about 75% of whom lived in households that include children.
Source: University of Michigan Health System