Medicines can be toxic to the tissues of the ear, so why isn’t there more regulatory guidance to ensure patient safety?
The harmful effects of ototoxicity can range from tinnitus to hearing loss, and these effects can sometimes be permanent.The FDA offers limited regulatory guidance supporting ototoxicity programs and our experts are driving regulations and study designs, according to Rachel Tapp,Senior Study Director of Neurobehavioral Sciences at Charles River’s Mattawan, Michigan, site.
For drugs already on the market, there is some clarity, but for totally new compounds, it’s another story entirely.
“The regulatory guidelines are quite murky around auditory safety,” says Tapp. “There is a guidance that’s been issued for the alternate routes of administration for compounds that are either being repurposed or intended for administration into other areas of the body. The problematic parts are the evaluations of the tissue and the assessment for hearing is not easily added to a standard tox protocol or profile study. So, you end up having to add either additional cohorts to get those endpoints, or you just end up looking at a separate standalone study.”
For more on the issue of ototoxicity and pharmaceuticals, tune into our latest episode of Sounds of Science.
And if you would like to learn more about Rachel’s research, click here and see how these studies are done.
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