The FDA officials have warned the parents to stay away from the teething medicines which have a popular numbing ingredient. The Federal Health Agencies have warned the companies which are making such medicines for toddlers and kids.
In a report published by FDA officials, it was stated that these drugs contain benzocaine which can pose serious threats to children especially those who aged 2 years or less. Many popular brands use benzocaine in the medicines which are used to cure teeth problems in adults. This ingredient also contains Anbesol and Orajel. It was further stated that the Federal Agency will take actions against those companies who are allegedly making such products for the children.
A new warning will also be imposed on the adult products. Prior to this warning, Regulators issued many warnings about benzocaine but people kept affecting with it. Benzocaine can cause serious blood problems which are related to the heart. The Federal Agency wants to completely remove such medicines from the market as there is a very little evidence that these drugs actually work. Scott Gottlieb, the commissioner of FDA said in a statement said that they highly recommend parents and caregivers not to use such medicines which have this numbing ingredient.
Benzocaine can cause serious blood and breathing problems in adults as well as in kids. The ingredient which is used as a pain-killer interferes with the essential oxygen-carrying proteins in our body. The side effects of benzocaine include a headache, shortness of breath and rapid heart rate.
All the baby-teeth medicines having benzocaine in them include Baby Orajel. And the packaging of such medicines states “instant pain-killer”. Many companies took quick actions after FDA’s warning as a New Jersey-based manufacturer said that they have abandoned the manufacturing of four brands having Orajel. And one of those four brands is Orajel Medicated Teething Swabs.
In a statement e-mailed by the company, it was stated that other than these four products all other Orajel products are in the production process. According to the American Academy of Pediatrics, using baby teeth creams is harmful as they wash out of the baby’s mouth quickly.
The company also recommended that the parents should massage the gums to relieve the pain. Back in 2006, 2011 and 2014 FDA also warned about the harmful teething drugs but at that time the company did not ask to remove the products from the retail stores. During 2009 to 2017, the health officials found almost 119 cases which were linked to benzocaine. And out of those 119 cases, four people died due to this numbing ingredient.
The current ban on these products came more than four years after a Public Citizen Group pledged FDA to ban the sales of baby-teething products. It was further reported that if the companies didn’t comply, then the FDA will take regulatory actions to remove the products. FDA officials are also trying that other benzocaine products should have a complete warning on the product packaging.
Gottlieb further said that the agency is doing its best to protect American Public from using products which are injurious to health and especially those which have no benefit. Th agency is taking steps to ensure a complete ban on such products and also raise awareness about the serious health risks which are associated with benzocaine related products, said Commissioner.
The FDA officials have written letters to those companies which are involved in the manufacturing of these products and the parents should also heed attention to the warning posted by the agency. The Commissioner further said that their agency is trying to patch up with the Congress over modernizing the over-the-counter framework of the drugs.
Benzocaine is used as a pain-killer for many conditions like gums irritation, canker sores, teething and sore throat. The products made from benzocaine are then sold in the form of gels, sprays, ointments, and creams under the brand Anbesol. Overuse of such products can lead to serious heart problems and sometimes cause death.
The Commissioner also announced that the agency-specific recommendations were made to the companies in order to protect patients. The company has also informed the manufacturers to label the drugs with up-to-date drug safety information.