FDA black box warning states lidocaine, benzocaine gel for infants teething pain can be fatal

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by Michael Heygood

The U.S. Food and Drug Administration is warning that prescription oral viscous lidocaine 2 percent solution and over-the-counter products containing benzocaine should not be used to treat infants and children with teething pain. In fact, no medicine should be used for teething pain.

The FDA has announced it is requiring a new Boxed Warning (“black box warning”) to be added to the drug label for oral viscous lidocaine 2 percent solution to highlight the warning. A Boxed Warning is the FDA’s strongest level of warning and signifies that medical studies indicate that the drug or use carries a significant risk of serious or even life-threatening adverse effects.

Parents have long used topical anesthetics to numb a baby’s gums during teething. However, according to the FDA’s announcement, oral viscous lidocaine solution—gum numbing gel— is not approved to treat teething pain, and use in infants and young children can cause serious harm, including death.

Back in 2011, the FDA raised safety concerns related to the use of over-the-counter topical benzocaine-containing teething preparations. At that time, the FDA warned that using OTC benzocaine gels for teething or mouth pain can cause a rare but serious condition called methemoglobinemia. Over-the-counter benzocaine gels and liquids are sold under brand names such as Anbesol, Hurricaine, Orajel, Baby Orajel, and Orabase.

Methemoglobinemia results in a large decrease in the amount of oxygen carried through the blood. Methemoglobinemia is life-threatening and can result in death. Unfortunately, even after the 2011 warning was issued, the FDA has continued to receive reports of methemoglobinemia in infants and children associated with OTC benzocaine gels and liquids.

In 2014, 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 or who had accidental ingestions.

The FDA is not recommending the use of any medication for teething pain. Instead, the FDA suggests following the American Academy of Pediatrics’ recommendations for treating teething pain: use a teething ring chilled in the refrigerator (not frozen) and/or gently rub or massage the child’s gums with your finger to relieve the symptoms.

According to the FDA, 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. More importantly, the FDA notes that when too much viscous lidocaine is given to infants and young children or when 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, according the FDA warning.

Get help for your family from an experienced attorney

Despite the efforts of federal regulators, thousands of children and infants are hospitalized each year because of dangerous drugs and other medical products, or because of mistakes by doctors or hospital staff. If your child has been injured by a dangerous product or by the negligence of health care professionals, you and your family are entitled to have an experienced, educated attorney on your side.

The lawyers at Heygood, Orr & Pearson have the knowledge, experience, and legal expertise to pursue serious injury or death claims o behalf of children and their families. Significantly, we also have the financial resources to handle even the most complex cases from start to finish. In many cases, our firm has invested hundreds of thousands of dollars in order to take the matter to trial.

At Heygood, Orr & Pearson, we are proud of the work we have done on behalf children and their families:

  • $36 million jury verdict for a child who suffered brain damage and other serious injuries in a bus crash on the way to church camp
  • $6.7 million verdict in a personal injury lawsuit against the United States for medical errors at a VA hospital that caused permanent brain damage to an 8-year-old child
  • $2.2 million jury verdict in a personal injury lawsuit involving the improper discharge of a newborn from the hospital with low glucose levels, resulting in brain damage

Our partners Michael Heygood, Jim Orr, and Eric Pearson are all Board Certified in Personal Injury Trial Law by the Texas Board of Legal Specialization. Mr. Heygood and Mr. Orr are additionally Board Certified in Civil Trial Advocacy Law by the National Board of Trial Advocacy. Our partners have also been voted by their peers as “Super Lawyers” in the state of Texas for several years running.* In addition, our firm is AV-rated, the highest legal and ethical rating available from the leading law firm rating service.

To find out more about how we can help with your case, please call us toll-free at 1-877-446-9001 for a free legal consultation from our attorneys. You can also receive a free case evaluation by following the link to our free contact form on this website.

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* Michael Heygood, James Craig Orr, Jr. and Eric Pearson were selected to the Super Lawyers List, a Thomson Reuters publication, for the years 2003 through 2014.