New restrictions on use of certain cough and pain medicine to treat children have been announced by the U.S. Food & Drug Administration (FDA). The government body warned parents and health care professionals that medicines containing codeine and tramadol carry "serious risks" to children under the age of 12, adding their use should also be limited in older children and nursing mothers.
"[We] encourage parents to review the ingredients of pain medicines to see whether they include codeine or tramadol, and cough medicines to see if they contain codeine. It’s also important to check non-prescription cough and cold medicines that may be sold over the counter, as some of these medicines also include codeine," said Douglas Throckmorton M.D., deputy center director for regulatory programs at the FDA's Center for Drug Evaluation and Research. Parents who find their children's medicine contains codeine or tramadol should consult with a health care provider before administering further doses, Dr Throckmorton added.
Under the latest restrictions, the strongest FDA warning - a Contraindication - against use of codeine and tramadol in children under 12 years of age has been introduced. A Contraindication was also added against use of tramadol as a pain treatment following tonsil/adenoid surgery in children under the ages of 18. A new Warning label also alerts against use of of both drugs in children between 12 and 18 years who have conditions such as sleep apnea, severe lung disease or obesity. Mothers were also warned against using these medications as unsafe levels of opioids may be passed to breastfeeding infants, causing risk of an adverse reaction.
Below are some of the medicines affected by the latest FDA restrictions.
Pain medication with codeine (or dihydrocodeine)
- Codeine Sulfate
- Butalbital, Acetaminopen, Caffeine, and Codeine phosphate
- Fiorinal with codeine
- Soma Compound with codeine
- Tylenol with codeine
- Generic products with codeine
- Synalgos-DC (with dihydrocodeine)
Cough medicine with codeine
- Promethazine with codeine
- Prometh VC with codeine
- Tuxarin ER
- Generic products with codeine
Medication with tramadol
- Ultram & Ultram ER
- Generic products with tramadol
Codeine is an opioid used to treat mild to moderate pain and is often combined with other drugs, such as acetaminophen or aspirin. It is used in painkillers (e.g. Codeine Sulfate) and is often added to prescription and over-the-counter cough & cold medication such as Promethazine-codeine. Tramadol is a prescription medication used to treat moderate or severe pain and is the active component in Conzip and other opioid agonists.
Since 2013, the FDA has warned against the use of medication containing codeine or tramadol in children following a tonsillectomy and/or andenoidectomy. However, the latest announcement warns health care professionals and parents that single-ingredient codeine and all tramadol medicines are approved only for use in adults. Nursing mothers have also been warned against codeine and tramadol-containing products.
The tightening of restrictions follows a review of adverse event reports involving the drugs dating back to 1969. It revealed codeine and tramadol use in pediatric patients risks causing serious breathing problems. The majority of serious side effects were experienced by those in the under 12 age group, which the review attributed to their ability to metabolize the codeine and tramadol faster than adults. This increases the risk that potentially dangerously high levels of active codeine and tramadol build up in the body, the review concluded. The FDA suggested alternative FDA-approved prescription medication or OTC medicine would be more suitable for cough and pain management in younger patients.
If you are unsure about which painkiller or cough medication is best for you or your children, seek advice from a pharmacist or your doctor.
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