The FDA has been warning parents about gum-numbing products for years, but chose to take this tougher stance because of continuing concerns about the health and safety risks posed by these products.
The agency has been warning about the products for a decade but said reports of illnesses and deaths have continued. Methemoglobinemia can cause red blood cells to stop carrying needed oxygen. The FDA also outlined these safety concerns in letters that the agency sent to manufacturers of these products.
For more information, visit the FDA website. "As part of the action, the agency is also requiring that prescription local anesthetics add updated warnings about their risk of this condition".
In a press release, the FDA claimed it was committed to protecting Americans from serious risks connected to certain products.
In response to the FDA's warning, Church and Dwight Co. You try every type of chilled teething toy you can get your hands on to relieve the pain in your baby's gums.
Revising the directions to direct parents and caregivers not to use the product in infants and children younger than 2 years. They're concerned about an ingredient - the drug benzocaine. Signs and symptoms of methemoglobinemia (which is a methemoglobin level above 10 percent) include shortness of breath, cyanosis, mental status changes, headache, fatigue, exercise intolerance, dizziness, and loss of hairlines.
The use of benzocaine can lead to methemoglobin in the blood which can lead to death. All drug products, including local anesthetics, should be stored out of reach of children.
If lidocaine is used, healthcare staff should be familiar with appropriate dosing, proper administration techniques, and safety monitoring; benzocaine sprays are not FDA-approved to numb mucous membranes of the mouth and throat or to suppress the gag reflex during medical procedures.
Wednesday's action comes more than four years after the consumer advocacy group Public Citizen petitioned the FDA to stop sales of teething products.