FDA: Don't use teething products with benzocaine

FDA warns teething medicines unsafe wants them off shelves

FDA warns teething medicines unsafe wants them off shelves

The Food and Drug Administration advises parents to stop using Orajel and other products marketed for teething babies containing benzocaine.

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 said that benzocaine can have a rare, but serious side effect on children, and especially those under 2 years old. Oral products for adults to treat sore throats, canker sores and irritation of the mouth and gums can also contain benzocaine. The agency said it will take action against companies that don't voluntarily remove their products for young children.

In Canada, officials at Health Canada required companies in 2012 to add "risk statements" to benzocaine products. For the past decade, the agency has been urging parents not to buy these products for their babies because of the reports of deaths and illnesses associated with the use of these teething gels and creams. It urged parents to avoid the products because of the risk of a potentially life-threatening condition called methemoglobinemia, which reduces oxygen in the blood. The AAP does not recommend these gels and suggests teething rings and massaging the gums to ease the teething pain.

Signs and symptoms include short breath and pale, gray, or blue-colored skin, lips and nails, as well as fatigue, dizziness, headache and a fast heart rate.

Scott Gottlieb, the FDA commissioner, recently proclaimed about the sunscreen products. Any mom or dad who's ever had to soothe a teething baby knows it's just about one of the toughest phases of parenthood. At present the package of Baby Orajel says, "Instant relief for teething pain". Now, it wants teething products off the market, noting there is little evidence they actually work.

Out of 119 cases reviewed in detail, mostly involving adults (with the benzocaine-containing product most commonly used during transesophageal echocardiography), 36 reported methemoglobinemia levels of 30% to 55% - a normal level ranges from 1% to 2%.

"Here you have a product that doesn't really help and can induce harm", says Meeks. The FDA will continue to monitor the safety of benzocaine products and will take additional actions as appropriate.

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