Epilepsy Drug Warnings May Slip Through Cracks08/19/13
MONDAY, Aug. 19 (HealthDay News) -- One-fifth of U.S.
neurologists are unaware of serious safety risks associated with
epilepsy drugs and are potentially risking the health of patients
who could be treated with safer medications, a new study
The 505 neurologists who took part in the survey between March
and July 2012 were asked if they knew about several epilepsy drugs'
safety risks recently identified by the U.S. Food and Drug
These risks included increased danger of suicidal thoughts or
behaviors linked with some newer drugs, a high risk for birth
defects and mental impairment in children of mothers taking
divalproex (brand name Depakote), and the likelihood of serious
hypersensitivity reactions in some Asian patients treated with
One in five of the neurologists said they did not know about any
of these risks. Neurologists who treat 200 or more epilepsy
patients per year were most likely to know all the risks, according
to the study, which was published online recently in the journal
Although this study focused on epilepsy drugs, the findings
suggest that the FDA needs to find better ways to inform doctors
about newly discovered drug safety risks, said the researchers from
Johns Hopkins University School of Medicine. Their results show
that warnings about these risks are not getting through to doctors
making important prescribing decisions.
There is no single place for neurologists to find updated drug
risk information, said study leader Dr. Gregory Krauss, a professor
of neurology. A few get emails from the FDA, while others get the
information from neurology societies, continuing medical education
courses or journal articles.
"There is poor communication from the FDA to specialists, and there's some risk to patients because of this," Krauss said in a Johns Hopkins news release.
"Unless it's a major change requiring the FDA to issue a black box warning on a product, important information appears to be slipping through the cracks," he said. "We need a more systematic and comprehensive method so that doctors receive updated safety warnings in a format that guarantees they will see and digest what they need to protect patients."
The Epilepsy Foundation has more about
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