Lidocaine May Kill Infants When Used For Teething Pain: FDA
Federal drug regulators are warning that the oral painkiller lidocaine should not be given to teething infants, due to a risk that it may cause severe injury or death.
The FDA issued a drug safety communication and consumer update on June 26, warning that prescription oral viscous lidocaine 2% should not be used for infants or children experiencing teething pain.
The agency has ordered that a boxed warning be placed on the prescription information label, which is the strongest label warning the FDA can require.
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According to reports submitted to the FDA’s Adverse Event Reporting System (FAERS), there have been at least 22 reported cases of oral viscous lidocaine 2% toxicity affecting children and infants under the age of 3.5 years. Of those cases, at least six resulted in the death of the child, three were life-threatening, 11 of the children ended up hospitalized, and two required medical intervention but not hospitalization.
Health experts often estimate that only about 10% of all adverse drug events are actually reported to FAERS, meaning the number of children actually injured or killed by oral use of lidocaine could be significantly higher.
The drug safety communication also reiterates the agency’s 2012 warning against the use of over-the-counter benzocaine gels and liquids, sold under the brand names like Anbesol, Hurricaine and Orajel.
The FDA warns that even after issuing the earlier warning, it continues to receive reports of children suffering a condition known as methemoglobinemia due to OTC benzocaine use. Methemoglobinemia dangerously decreases the amount of oxygen carried in the blood, and can cause injury or even death.
Additionally, in 2010, Standard Homeopathic Company had to issue a Hyland’s Teething Tablet recall following an FDA warning that it was also linked to child injury risks. The recalled tablets contained varying amounts of belladonna, a potentially toxic ingredient, and the FDA had received a number of FAERS reports suggesting children had suffered belladonna toxicity after ingesting the pills.
The FDA also got reports that children had taken more pills than they should because the manufacturer had not supplied a child-proof cap.
In this week’s warning, the FDA recommended parents simply avoid the use of all topical pain relievers for the treatment of teething pain.
“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,” according to the FDA warning. “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 agency urges parents to follow the recommendations of the American Academy of Pediatrics, which recommends that parents to use a chilled, but not frozen, teething ring to soothe teething pain, or to simply gently rub the child’s gums with your fingers to soothe the pain.
JavierFebruary 3, 2016 at 5:41 am
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