Is there a recall on Orajel?
The following products are affected by this recall: Orajel™ Medicated Teething Gel 0.33 ounces: UPC 3-10310-03313-2. Orajel™ Medicated Daytime & Nighttime Teething Gel 0.18 ounces each (Horizontal): UPC 3-10310-31955-7.
Why was Orajel recalled?
On May 22, the FDA issued a warning about over-the-counter products containing benzocaine, citing “serious safety concerns” and a “lack of efficacy for teething.” The painkiller can be found in Baby Orajel, a gel that can be spread over the gums, as well as in other sprays, gels, and lozenges.
Why do doctors not recommend Orajel?
Just Say No to Orajel (Benzocaine) for Teething The FDA is taking action against the use of benzocaine products because they have the potential to cause a condition called methemoglobinemia. Methemoglobinemia is a potentially deadly condition that causes blood to carry less oxygen.
Why did they stop making Orajel?
U.S. regulators ordered companies to stop selling infant teething products containing benzocaine in 2018, saying they “carry serious risks and provide little to no benefit for the treatment of oral pain including teething.”
Is Orajel toxic?
Orajel used in the mouth may cause a condition in which the oxygen in your body tissues can become dangerously low. This is a potentially fatal condition called methemoglobinemia (met-HEEM-oh glo-bin-EE-mee-a).
Can Orajel cause methemoglobinemia?
Any potential benefits of using these products to treat teething pain do not outweigh their risks. Benzocaine and other local anesthetics can cause methemoglobinemia, a serious condition in which the amount of oxygen carried through the blood is greatly reduced.
What are the side effects of Orajel?
What are the side effects of Orajel (Benzocaine Topical)?
- a headache, tiredness, confusion;
- fast heartbeats;
- feeling light-headed or short of breath; and.
- pale, blue, or gray appearance of your skin, lips, or fingernails.
What can I use instead of Orajel?
Orajel Alternatives Compared
- Hydrogen peroxide topical.
- Hurricaine.
- OraMagic Plus.
- Topex.
- Kank-a.
- Anbesol Baby.
Is Orajel made in China?
Orajel Facts: Helps to remove plaque for cleaner teeth. Other Information: Do not use if outer blister on card is torn or cut before first use. Safe if swallowed when used as directed. Toothbrush is made in China.
What happens if you use too much Orajel?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of benzocaine topical applied to the skin can cause life-threatening side effects such as uneven heartbeats, seizure (convulsions), coma, slowed breathing, or respiratory failure (breathing stops).
How common is methemoglobinemia from Orajel?
The second most common dosage form was oral gel (n=20). Four cases resulted in death, including one infant and three adults. In 36 of the 119 cases (30 percent) the reported methemoglobin level was 30 to 55 percent, with the normal concentration typically around one to two percent.
Does methemoglobinemia go away on its own?
The condition is benign. There is no effective treatment for people with a congenital form who develop an acquired form. This means that they should not take drugs such as benzocaine and lidocaine. People who acquire methemoglobinemia from medications can completely recover with proper treatment.