Product News and Recalls

FDA Investigating Codeine Use in Children under 18

fda investigating dangers of codeine use in childrenThe U.S. Food and Drug Administration (FDA) has announced it is investigating the safety of using codeine-containing products to treat coughs and colds in children under the age of 18. According to the agency, use of codeine, an opioid pain reliever, in this age group can result in serious side effects such as difficult or slowed breathing.

This is not the first time the FDA has alerted the public to the potential risks of codeine. In 2013, the agency issued a drug safety communication warning about using codeine to relieve pain in children following tonsillectomy or adenoidectomy procedures [link FDA Warns against Codeine Use in Children after Certain Procedures]. The warning was issued after the FDA received multiple reports of children dying or suffering severe side effects after taking codeine for post-operative pain relief. The agency followed up by adding a Boxed Warning to the labels of codeine-containing drugs, as well as a contraindication for their use in children after certain procedures.

The current communication comes after the European Medicines Agency (EMA) announced in April that codeine was not to be administered to treat coughs or colds in children under 12 years of age. The EMA further warned against use of codeine-containing drugs in children aged 12 to 18 years who already have breathing problems.

The FDA is investigating the possible link between certain child codeine use and respiratory complications. The agency instructs parents and practitioners to be alert for signs of slow or labored breathing, confusion, and unusual sleepiness, and to seek immediate medical attention should any of these symptoms manifest.

Ask your doctor about any health complications you may have. If you or a loved one was injured by a codeine-containing product, contact Lopez McHugh today to speak free of charge with one of our experienced pharmaceutical attorneys. You may be entitled to legal damages.