Consumer-health companies must stop selling products such as Baby Orajel to parents with teething infants, USA health regulators said, given the risk of developing a potentially deadly condition that reduces oxygen levels in the blood.
The agency also sent a letter asking manufacturers to stop selling products aimed at babies and toddlers, prompting at least one major company to discontinue its teething products. Additionally, the agency is requesting that companies add new warnings to all other oral health products containing benzocaine to describe "certain serious risks". Inc., makers of this product based in New Jersey yesterday, they would stop the further production of the four different Orajel teething brands as well as Orajel Medicated Teething Swabs. Health Canada says the pain reliever can cause a rare but serious blood condition called methemoglobinemia (MHb), which causes breathing problems and can lead to death.
FDA commissioner Scott Gottlieb said in a release there are "no demonstrated benefits" from the benzocaine products.
The FDA also says it can be unsafe.
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The agency said parents of teething children should follow advice from the American Academy of Pediatrics. Instead, the group recommends giving babies teething rings or simply massaging their gums to relieve pain.
According to health officials at the Food and Drug Administration (FDA), popular teething remedies for babies may not be free from dangers. The over-the-counter medicines have brand names Anbesol, Baby Orajel, Cepacol, Chloraseptic, Hurricaine, Orabase, Orajel and Topex, as well as store brands and generics.
Consumers should stop using over-the-counter teething products that contain benzocaine because they pose a serious health threat to infants and young children, US health officials warned Wednesday. Methemoglobinemia can cause red blood cells to stop carrying needed oxygen. Symptoms include shortness of breath, headache and rapid heart rate.
They also warn against using homeopathic alternatives. Healthcare professionals who use local anesthetics are being advised to minimize the risk of methemoglobinemia by monitoring patients for signs and symptoms, using co-oximetry when possible, and having resuscitation equipment and medications available, including methylene blue.