FDA Adds Severe Warning to Oral Viscous Lidocaine Solutions After Cases of Severe Reactions and Deaths
The FDA has released a new warning regarding both prescription and OTC (over-the-counter) oral viscous lidocaine solution, stating that it is not approved to treat teething pain and that health care providers should not prescribe the drug to children with teething pain. The agency now requires that a Boxed Warning, it’s most stringent warning, be placed on the labels of the drug.
The new warning comes after the FDA studied 22 case reports in which infants or young children had serious reactions to oral viscous lidocaine solution. Of those, there were six reported deaths related to the drug. In other cases, when too much lidocaine is used or accidentally swallowed, it can result in seizures, severe brain injury and problems with the heart which may also lead to hospitalization and/or death. As such, the FDA is also requiring that drug companies revise their Warnings and Dosage and Administration sections of drug labels to include the risk of severe adverse events if the drug is prescribed for approved use.
The FDA has also previously sent out warnings related to OTC topical benzocaine teething medications, which have resulted in a rare but life-threatening condition called methemoglobinemia. Some OTC benzocaine gels and liquids are sold under brand names such as Anbesol, Hurricaine, Orajel, Baby Orajel, and Orabase.
The FDA is discouraging parents from giving their children OTC topical medications for teething pain as they have been deemed unnecessary and not useful since it will wash out within a few minutes. Instead, parents should use a chilled teething ring and/or gently rub the child’s gums with a finger to relieve pain.
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