The FDA recently released a warning over a popular numbing ingredient, benzocaine, that is found in many teething products designed for babies and toddlers. Various gels and cream that contain benzocaine have been shown to cause serious risk to children, even posing the risk of death.
The warning comes as a result of research showing that benzocaine can lead to methemoglobinemia, a rare blood condition associated with breathing problems. Essentially, oxygen level in blood can become dangerously low – in some instances fatal. Common symptoms of this condition can include lightheadedness, headache, irregular heartbeat, shortness of breath, sleepiness, uncommonly pale skin and nails turning blue or gray. Babies and toddlers that show signs of these symptoms should immediately seek medical attention.
There were 119 cases reviewed between 2009 and 2017 associated with the blood disorder linked to benzocaine. Of those cases, four were fatal.
Products that contain benzocaine are sold as gels, sprays, ointments and various solutions. Common brands include Anbesol, Baby Orajel, Cepacol, Chloraspetic, Hurricaine, Orabase, Orajel and Topex. Benzocaine is not only found in many products for young children, but also in products used by adults. A surprisingly large number of over-the-counter products contain the ingredient. While the FDA is not calling for the removal of products containing the ingredient, they have requested manufacturers to stop selling teething care items using this ingredient. They have also advised companies to update warning labels on such products.
These warnings are not new. The FDA has issued warnings about benzocaine for many years – but the numbers of illnesses and deaths hasn’t decreased. The FDA’s efforts to remove these products from consumption have increased drastically in recent months – even claiming that legal action may be taken against companies that do not remove the products designed for young children.
The American Academy of Pediatrics has advised parents to use soothing alternatives, such as rubber teething products or rubbing babies’ gums for temporary relief. The FDA has stated that a lack of effectiveness for teething and the obvious safety concerns is what has led to the decision to call for the removal of baby products containing benzocaine.
For more information on the FDA release, visit fda.gov.
Categories: Defective Products, Product Liability
