A new statement by the U.S. Food and Drug Administration (FDA) has required the addition of a boxed warning on oral lidocaine. Boxed warnings by the FDA are the most serious warning issued by the agency. In a release directly from the FDA, the public was warned against the use of prescription oral lidocaine 2 percent solutions in treating infant teething pain. It has been found that the prescription drug can cause severe harm and even death if used with young children.
The oral solution has not been approved for use in treating teething pain. Instead, the FDA recommends using a teething ring or simply massaging the child’s gums gently using a finger. There have been numerous recent cases of lidocaine use leading to overdose in children. Possible injuries include seizures, major brain injury, and heart complications.
The FDA reviewed 22 case reports of overdoses in children aged from 5 months to 3.5 years. The cases studied included accidental ingestion as well as reactions to being given the solution to treat tooth pain.
In the statement by the FDA, the agency reported that topical pain relievers are not only dangerous but also ineffective in children. This is because the topical application is quickly washed off in the infant’s gums.
The warnings not only pertain to prescription drugs; the FDA is also recommending that caregivers stop using over-the-counter medications for this purpose. This follows a 2011 statement by the agency that warned against using topical benzocaine gels for teething treatment. It was found that the use of these gels causes a rare but serious condition called methemoglobinemia. The condition very seriously decreases oxygen levels in the blood and can be fatal.
If you or a loved one has suffered an injury as a result of pharmaceutical negligence, you may be entitled to financial compensation. Contact a Lopez McHugh pharmaceutical attorney today at (877) 737-8525 or fill out a contact form on our website for a free initial consultation.