The American Food and Drug Safety Association (FDA) mentioned in a recently released drug safety newsletter that The 2% lidocaine gel used for oral anesthesia should not be used to relieve toothache in infants due to the serious risks it may cause. The agency said: [Oral treatment of toothache with 2% lidocaine gel is not approved, and infants may cause serious harm or even death due to the use of this drug.]
This year, FDA evaluated 22 related cases of oral 2% lidocaine gel used in infants to treat oral diseases (including toothache and stomatitis) or swallowing excessive 2% lidocaine gel by mistake, and reported serious side effects (including death) in the above cases.
FDA warns: [Local analgesics and other agents applied to the gums have little effect, Because children’s oral cavity will quickly wash them out. If excessive sticky lidocaine is used on infants and young children, it may cause inadvertent swallowing of excessive drugs, resulting in epilepsy, serious brain injury and heart diseases. Excessive lidocaine due to wrong dosage or accidental intake of drugs can lead to hospitalization or death of children.]
The FDA said it needed to give black-box warnings to such prescriptions to highlight their risks. Health experts have also been asked not to recommend or prescribe 2% lidocaine gel for toothache. Guardians and children should follow the advice of the American Association of Pediatrics by placing rubber rings in the refrigerator to cool (not in the frozen layer) to relieve the pain, or gently rubbing or massaging the affected part with fingers to relieve the pain.
As early as 2011, Medscape Medical News reported that the use of benzocaine gel sold without a doctor’s prescription to relieve toothache or oral problems may cause [methemoglobinemia]. Although the probability is very small, the consequences will be very serious once it occurs!