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Lidocaine Viscous: drug safety warning

By Tim Sandle     Jul 10, 2014 in Health
Washington - The U.S. FDA has notified health professionals, their provider organizations and caregivers for infants, that prescription oral viscous lidocaine 2% solution should not be used to treat infants and children with teething pain.
The U.S. Food and Drug Administration (FDA) is requiring a "Boxed Warning" to be added to the prescribing information (label) to highlight this information. Oral viscous lidocaine solution is not approved to treat teething pain, and use in infants and young children can cause serious harm, including death.
Lidocaine viscous, a local anesthetic, is used to treat the pain of a sore or irritated mouth and throat often associated with cancer chemotherapy and certain medical procedures. Lidocaine viscous is not normally used for sore throats due to cold, flu, or infections such as strep throat.
The Agency warns, according to WFMY News, that topical pain relievers and medications that are rubbed on the gums are not necessary or even useful because they wash out of the baby’s mouth within minutes. When too much viscous lidocaine is given to infants and young children or they accidentally swallow too much, it can result in seizures, severe brain injury, and problems with the heart. Cases of overdose due to wrong dosing or accidental ingestion have resulted in infants and children being hospitalized or dying.
The new advice comes after the FDA reviewed 22 case reports of serious adverse reactions, including deaths, in infants and young children 5 months to 3.5 years of age who were given oral viscous lidocaine 2 percent solution for the treatment of mouth pain, including teething and stomatitis, or who had accidental ingestions.
The FDA's recommendation is that health care professionals should not prescribe or recommend this product for teething pain. Parents and caregivers should follow the American Academy of Pediatrics’ recommendations for treating teething pain. This is:
Use a teething ring chilled in the refrigerator (not frozen).
Gently rub or massage the child’s gums with your finger to relieve the symptoms.
The FDA is also encouraging parents and caregivers not to use topical medications for teething pain that are available over the counter (OTC) because some of them can be harmful.
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