| IMPORTANT WARNING:
| WHY is this medicine prescribed?
| HOW should this medicine be used?
| What should I do IF I FORGET to take a dose?
| What SIDE EFFECTS can this medicine cause?
| What should I know about STORAGE and DISPOSAL of this medication?
| What OTHER INFORMATION should I know?
[Posted 06/26/2014]ISSUE:FDA notified health professionals, their provider organizations and caregivers for infants, that prescription oral viscous lidocaine 2% solution should not be used to treat infants and children with teething pain. FDA is requiring a Boxed Warning to be added to the prescribing information (label) to highlight this information. Oral viscous lidocaine solution is not approved to treat teething pain, and use in infants and young children can cause serious harm, including death.
Topical pain relievers and medications that are rubbed on the gums are not necessary or even useful because they wash out of the baby's mouth within minutes. When too much viscous lidocaine is given to infants and young children or they accidentally swallow too much, it can result in seizures, severe brain injury, and problems with the heart. Cases of overdose due to wrong dosing or accidental ingestion have resulted in infants and children being hospitalized or dying.
BACKGROUND:In 2014, FDA reviewed 22 case reports of serious adverse reactions, including deaths, in infants and young children 5 months to 3.5 years of age who were given oral viscous lidocaine 2 percent solution for the treatment of mouth pain, including teething and stomatitis, or who had accidental ingestions. See further details in the FDA Drug Safety Communication.
RECOMMENDATION:Health care professionals should not prescribe or recommend this product for teething pain. Parents and caregivers should follow the American Academy of Pediatrics' recommendations for treating teething pain.
- Use a teething ring chilled in the refrigerator (not frozen).
- Gently rub or massage the child's gums with your finger to relieve the symptoms.
FDA is also encouraging parents and caregivers not to use topical medications for teething pain that are available over the counter (OTC) because some of them can be harmful. FDA recommends following the American Academy of Pediatrics' recommendations to help lessen teething pain. For more information visit the FDA website at: Web Siteand Web Site.
WHY is this medicine prescribed?
Lidocaine viscous, a local anesthetic, is used to treat the pain of a sore or irritated mouth and throat often associated with cancer chemotherapy and certain medical procedures. Lidocaine viscous is not normally used for sore throats due to cold, flu, or infections such as strep throat.
This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
HOW should this medicine be used?
Lidocaine viscous comes as a thick liquid and should be shaken well before using. Lidocaine viscous usually is used as needed but not more frequently than every 3 hours, with a maximum of 8 doses in 24 hours. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use lidocaine exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.
For a sore or irritated mouth, the dose should be placed in the mouth, swished around until the pain goes away, and spit out.
For a sore throat, the dose should be gargled and then may be swallowed. To avoid or decrease side effects, use the minimum amount of drug needed to relieve your pain.
Because lidocaine viscous decreases the feeling in your mouth and/or throat, it may affect your ability to swallow. Avoid eating for at least 1 hour after you have used this drug. You should also avoid chewing gum while using this medication.
What SPECIAL PRECAUTIONS should I follow?
Before using lidocaine viscous,
- tell your doctor and pharmacist if you are allergic to lidocaine, anesthetics, or any other drugs.
- tell your doctor and pharmacist what prescription and nonprescription medications you are taking, including vitamins.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using lidocaine, call your doctor.
What should I do IF I FORGET to take a dose?
Use the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.
What SIDE EFFECTS can this medicine cause?
Lidocaine viscous may cause side effects. If you experience any of the following symptoms, call your doctor immediately:
- blurred or double vision
- irregular heartbeat
- seizures or convulsions
- ringing in the ears
- severe itching or burning
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at
] or by phone [1-800-332-1088].
What should I know about STORAGE and DISPOSAL of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
What OTHER INFORMATION should I know?
Keep all appointments with your doctor.
Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: June 26, 2014.