Other safety alerts
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| The United States: Drug Safety Communication: Lidocaine Viscous: Boxed Warning Required - Should Not Be Used to Treat Infants and Children with Teething Pain |
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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.
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.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm402790.htm
In Hong Kong, there are 47 registered pharmaceutical products containing lignocaine for topical oral applications. So far, the Department of Health (DH) has not received any local adverse drug reaction report related to these products. In view of the above FDA's announcement, a letter to healthcare professionals will be issued, and the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board. The DH will keep vigilant on any safety update related to lignocaine for topical oral applications by other drug regulatory authorities.
Ends/ Friday, June 27, 2014
Issued at HKT 13:00
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