FDA Labelling Changes for Children’s Use of Codeine and Tramadol Products

Codeine Labelling Requirements

Codeine and Tramadol are narcotics frequently included in medications to treat pain or cough. A safety review launched by the FDA in 2015 found that the drugs have serious risks for patients under the age of 12, including slowed or difficult breathing and death. They also carry a risk for patients up to age 18 years old who have breathing troubles. Children and some adults break down codeine and tramadol faster than normal, causing the level of opioids in these patients to rise too high and too quickly.

The FDA reviewed adverse event reports submitted between January 1969 and May 2015. It identified 64 cases of serious breathing problems, including 24 deaths, with codeine-containing medicines in children younger than 18 years. Labelling requirements for prescription Codeine and Tramadol products have been updated to include the following:

  • contraindications for the use of codeine or tramadol in all children younger than 12 years
  • warnings about their use in children 12-18 years of age with certain medical conditions such as obesity, obstructive sleep apnea, or severe lung disease, which may increase the risk of serious breathing problems
  • stronger warnings recommending against their use in nursing mothers due to possible adverse effects to infants such as excessive sleepiness, difficulty breastfeeding, or serious breathing problems that could result in death.

Tramadol products will also be required to include contraindications for post-operative pain management in children up to age 18 years of age who have undergone the removal of the tonsils and/or adenoids. This is already required for codeine products.

The updated warnings will only apply to prescription drugs containing tramadol or codeine. The FDA is considering other regulations that would be applied to Over the Counter medications.

Health Canada and the European Medicines Agency have also issued similar warnings over the past 5 years after their safety reviews had similar findings to this most recent one by the FDA.

If you have any questions, please feel free to contact Focal Point Research Inc.  We are industry leading Drug Regulatory Consultants that you can trust to help guide your company in the right direction.