FDA Warns Of “Serious And Potentially Fatal Blood Disorder” In Oral OTC Benzocaine Products

by Kim Boateng Posted on May 23rd, 2018

Silver Spring, Maryland, USA: The U.S. Food and Drug Administration, FDA,  today, warned that over-the-counter (OTC) oral drug products containing benzocaine should not be used to treat infants and children younger than 2 years. FDA is also warning that benzocaine oral drug products should only be used in adults and children 2 years and older if they contain certain warnings on the drug label.

These products carry serious risks and provide little to no benefits for treating oral pain, including sore gums in infants due to teething. Benzocaine, a local anesthetic, can cause a condition in which the amount of oxygen carried through the blood is greatly reduced. This condition, called methemoglobinemia, can be life-threatening and result in death. Due to the significant safety risk of methemoglobinemia, FDA manufacturers that they should stop marketing OTC oral drug products for treating teething in infants and children younger than 2 years. If companies do not comply, FDA will take action to remove these products from the market.

FDA also urged manufacturers of OTC oral drug products containing benzocaine for adults and children 2 years and older to make the following changes to the labels of their products:

  • Adding a warning about methemoglobinemia;
  • Adding contraindications, FDA’s strongest warnings, directing parents and caregivers not to use the product for teething and not to use in infants and children younger than 2 years; and
  • Revising the directions to direct parents and caregivers not to use the product in infants and children younger than 2 years.

BACKGROUND: Benzocaine is a local anesthetic contained in some OTC products for the temporary relief of pain due to minor irritation, soreness, or injury of the mouth and throat. Benzocaine products are marketed as gels, sprays, ointments, solutions, and lozenges under brand names such as Anbesol, Orabase, Orajel, Baby Orajel, Hurricaine, and Topex, as well as store brands and generics. Prescription local anesthetics include articaine, bupivacaine, chloroprocaine, lidocaine, mepivacaine, prilocaine, ropivacaine, and tetracaine.

RECOMMENDATION: 
FDA continues to monitor the safety and effectiveness of OTC benzocaine products and intend to take additional actions in the future as needed. FDA will notify the public about any updates. In addition to recent actions regarding OTC benzocaine products, FDA is also requiring a standardized methemoglobinemia warning to be included in the prescribing information of all prescription local anesthetics.

Parents and caregivers should follow the American Academy of Pediatrics’ recommendationsdisclaimer icon for treating teething. Gently rub or massage the child’s gums with one of your fingers.

  • Use a firm rubber teething ring.

Topical pain relievers and medications that are rubbed on the gums are not useful because they wash out of a baby’s mouth within minutes. FDA has previously cautioned parents and caregivers to not give certain homeopathic teething tablets to children. Alternative treatments for adults who experience mouth pain may include dilute salt water mouth rinse and OTC pain relief medications. Adults should follow the American Dental Association’s recommendations for mouth sores:

  • Schedule regular oral health checkups
  • Keep a diary of what you eat and drink
  • Keep a list of oral hygiene products you have been using
  • Avoid all tobacco products
  • If you drink alcoholic beverages, do so in moderation
  • See your dentist if you notice any change in your mouth.

Consumers using benzocaine products to treat mouth pain should seek medical attention immediately for signs and symptoms of methemoglobinemia. These include pale, gray or blue-colored skin, lips, and nail beds; shortness of breath; fatigue; confusion; headache; lightheadedness; and fast heart rate. Signs and symptoms of methemoglobinemia may appear within minutes to one to two hours after using benzocaine. Symptoms may occur after using benzocaine for the first time, as well as after prior uses.

Health care professionals should warn patients of the possibility of methemoglobinemia and advise them of the signs and symptoms when recommending or prescribing local anesthetic products. Some patients are at greater risk for complications related to methemoglobinemia. This includes those with breathing problems such as asthma, bronchitis, or emphysema; heart disease, and the elderly. Health care professionals using local anesthetics during medical procedures should take steps to minimize the risk for methemoglobinemia. These include monitoring patients for signs and symptoms suggestive of methemoglobinemia; using co-oximetry when possible; and having resuscitation equipment and medications readily available, including methylene blue.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form at https://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/ucm2007307.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

American Academy of Pediatrics’ recommendations for treating teething

Teething: 4 to 7 Months

​Teething usually starts during these months. The two front teeth (central incisors), either upper or lower, usually appear first, followed by the opposite front teeth. The first molars come in next, followed by the canines or eyeteeth.

The timing of teething:

There is great variability in the timing of teething. If your child doesn’t show any teeth until later than this age period, don’t worry. The timing may be determined by heredity, and it doesn’t mean that anything is wrong.

How to ease your baby’s discomfort:

Teething occasionally may cause mild irritability, crying, a low-grade temperature (but not over 101 degrees Fahrenheit or 38.3 degrees Celsius), excessive drooling, and a desire to chew on something hard. More often, the gums around the new teeth will swell and be tender. Try gently rubbing or massaging the gums with one of your fingers. Teething rings are helpful, too, but they should be made of firm rubber. (The teethers that you freeze tend to get too hard and can cause more harm than good.) Pain relievers and medications that you rub on the gums are not necessary or useful since they wash out of the baby’s mouth within minutes. Some medication you rub on your child’s gums can even be harmful if too much is used and the child swallows an excessive amount. Stay away from teething tablets that contain the plant poison belladonna and gels with benzocaine. Belladonna and benzocaine are marketed to numb your child’s pain, but the FDA has issued warnings against both due to potential side effects.​ If your child seems particularly miserable or has a fever higher than 101 degrees Fahrenheit (38.3 degrees Celsius), it’s probably not because she’s teething, and you should consult your pediatrician.

How should you clean the new teeth?

Simply brush them with a soft child’s toothbrush when you first start seeing her teeth. To prevent cavities, never let your baby fall asleep with a bottle, either at nap time or at night. By avoiding this situation, you’ll keep milk from pooling around the teeth and creating a breeding ground for decay.

 

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Kim Boateng

Kim Boateng

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