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(Last Updated On: June 15, 2018)

Prescription Opioid Cough and Cold Medicine: FDA Requires Labeling Changes

The National Agency for Food and Drug Administration and Control has been informed by United States Food and Drug Administration that it is requiring safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone.

Codeine and Hydrocodone are available in combination with other medicines, such as antihistamines and decongestants in prescription medicines for the treatment of coughs and symptoms associated with allergies or common cold.

Reason for labeling changes

  • To limit the use of these products to adults 18 years and older because the risks of these medicines outweigh their benefits in children younger than 18.
  • To add safety information about the risks of misuse, abuse, addiction, overdose, death, and slowed or difficult breathing to the Boxed Warning.

Affected Products include all Prescription Opioid Cough and Cold Medicines containing codeine and hydrocodone.

Healthcare Provider Action

  • Healthcare Providers should be aware that FDA is changing the age range for which these medicines are indicated as they will no longer be indicated for use in children and their use in this age group is not recommended.
  • Healthcare Providers should reassure parents that cough due to cold and upper respiratory infection in children is self-limited and generally does not need to be treated, but where necessary, alternative medicines such as OTC product dexthromethorphan and prescription product benzonatate products are available.
  • Report adverse events related to the use of these products to NAFDAC PRASCOR (20543 Toll freefrom all networks) or via pharmacovigilance @nafdac.gov.ng.

NAFDAC…… Safeguarding the health of the Nation

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