The agency asked manufacturers to stop the sale of teething products and include warnings for other over-the-counter oral health products which contain benzocaine, according to a statement released on May 23.
The FDA has asserted that if these product-manufacturing companies do not stop selling them, FDA will take strict actions against the companies to ban these products out of stores. New warnings will be added to products for adults. They can occur a couple of minutes to several hours after receiving a dose of a product containing benzocaine.
Regulators have warned about the dangers of benzocaine in the past, AP said.
The FDA claimed the teething products with benzocaine has no health benefits because it must be removed immediately from the mouth.
On the American Academy of Pediatrics site, HealtyChildren.org, the page on teething babies has a warning that reads, "Stay away from teething tablets that contain the plant poison belladonna and gels with benzocaine". Instead of using over-the-counter products, parents can help their children cope with teething symptoms.More news: Time lapse from Hawaii observatory shows eruptions at Kilauea
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When buying OTC oral health drug products, consumers should refer to the OTC Drug Facts Label to see if benzocaine is an active ingredient and, if using these products, look for signs and symptoms of methemoglobinemia.
Benzocaine is sometimes sold under the brand names Orajel and Anbesol and is an ester local anesthetic, often used as a topical pain reliever or in cough drops. Methemoglobinemia can be deadly as it causes the amount of oxygen carried in the blood to drop.
Director Janet Woodcock said the FDA is working to "add warning information about methemoglobinemia and a contraindication against use for teething pain and against use in children under 2 years of age to the remaining oral health care drug products containing benzocaine".
Benzocaine, a local anesthetic agent is also found in over-the-counter products that are used for mouth sores, mouth ulcers, toothaches, cold sores etc. It is made by the New Jersey-based Church and Dwight Co. It also repeated a previous warning to avoid homeopathic teething products, which may have a variety of possible side effects. Symptoms include shortness of breath, headache and rapid heart rate.