A products liability warning has been issued by the Food and Drug Administration regarding infant teething gels. Teething gels are marketed as Anbesol, Hurricaine, Orajel, Baby Orajel and Orabase.
The FDA will require a new “black box warning” to be placed on the drug label for teething gels containing lidocaine two percent solution and benzocaine.
Parents of teething infants have used the topical anesthetia gel to numb the baby’s gums. According to the FDA warning, oral viscouse lidocaine is not approved for treating teething discomfort. The FDA warned that use of the teething gel in infants and children can cause serious injury and even death.
The FDA first raised a products liability concern over the teething gel in 2006. In 2011, the FDA repeated the warning. At that time, the FDA warned that use of benzocaine gels could result in a rare but very serious condition called methemoglobinemia. Methemoglobinemia is a disorder in which the amount of oxygen carried through the blood stream is greatly reduced. In the most severe cases, death can result. Symptoms of methemoglobinemia are not always apparent, causing parents to be unable to recognize the signs of methemoglobinemia. Signs of methomoglobinemia include pale, gray or blue colored skin, lips and nail beds, shortness of breath, fatigue, confusion, headache, light-headedness and rapid heart rate. If not treated, or if treatment is delayed, methemoglobinemia can cause permanent brain injury or death due to the insufficient oxygen in the blood.
FDA Pharmacist Mary Ghods, R.Ph. said “Symptoms can occur within minutes to hours after benzocaine use. They can occur after using the (gel) for the first time, as well as after several uses.”
Since the first warnings in 2006, the FDA has received 29 reports of benzocaine gel methemoglobinemia. Fifteen of those cases were in chldren under the age of two.
Although adults can be affected by the gels, children under the age of two years are most at risk.
The products liability attorneys at Clark, Perdue & List have the knowledge and experience to successfully represent individuals who have been injured as a result of a dangerous or defective product. If you believe that you or a loved one has a products liability claim, call Clark, Perdue & List.