- September 2, 2017
- Posted by: nafdacadmin
The Agency have been notified by the U.S. Food and Drug Administration of its restriction of codeine and tramadol medicines use in children younger than 12 years.
Codeine is approved to treat pain and cough, and tramadol is approved to treat pain.
These medicines have been found to be capable of posing serious health risks including slowed or difficult breathing condition and death in children younger than 12 years.
Single ingredient codeine and all tramadol containing products are FDA approved only for use in adults. FDA is also recommending against the use in breastfeeding mothers due to possible harm to their infants.
The U.S. FDA is also requiring several changes to labels of all prescription medicines containing codeine and tramadol indicating the following;
- Codeine should not be used to treat pain or cough and tramadol should not be used to treat pain in children younger than 12 years.
- Tramadol should not be used in children younger than 18 years to treat pain after surgery to remove the tonsil and/or adenoids.
- Recommend against use of tramadol and codeine in adolescents between 12 and 18 years who are obese or have conditions such as obstructive sleep apnea or severe lung disease, which may increase the risk of serious breathing problems.
- Codeine and tramadol use in breastfeeding mothers is not recommended due to risk of serious health hazards to the breastfed infants, such as excess sleepiness, difficulty breastfeeding, or serious breathing problem that could result to deaths.
Healthcare Provider Action
- Recommend over-the-counter (OTC) or other approved prescription medicines for cough and pain management in children younger than 12 years and adolescents younger than 18 years especially those with certain genetic factors, obesity, or obstruction sleep apnea and other breathing problems.
- Healthcare providers and patients should always lookout for tramadol or codeine on labels of prescription bottles.
- Watch out for signs of breathing problems, slow or shallow breathing, difficulty or noisy breathing, unusual sleepiness and trouble breastfeeding.
- Report adverse events relating to use of these medicines to NAFDAC PRASCOR (20543-Toll free from all networks) or via firstname.lastname@example.org
NAFDAC………Safeguarding the Health of the Nation!!!