As a result, FDA is requiring several changes to the labels of all prescription medicines containing these drugs. The decision to change the labeling was made in response to the fact that the "serious risks of these medicines outweigh their potential benefits in this population", said the announcement from the FDA. Labeling for the medications also is being updated with additional safety information for adult use - including an expanded Boxed Warning, the FDA's most prominent warning? notifying about the risks of misuse, abuse, addiction, overdose and death, and slowed or hard breathing that can result from exposure to codeine or hydrocodone.
Codeine is a pain reliever that is sometimes used in combination with other medications to treat severe cough, according to the FDA.
Instead, they will be labeled for use only in adults aged 18 and older. At the time, officials expressed concerns that some children are "ultrarapid metabolizers" who process such drugs very quickly, resulting in dangerously high levels that can depress breathing and lead to death. Cough and cold medicines that have opioid ingredients, such as codeine or hydrocodone, should no longer be given to children of any age.
The required safety labeling changes announced today are based on an extensive review of available data and expert advice shared at meetings to explore the pediatric use of opioid-containing cough and cold products. Experts and pediatricians advised that while coughs in those under 18 sometimes do require treatment, usually the coughs were caused by a cold or upper respiratory infection; the risks of the opioid medication would outweigh benefits.
Not only will these medications get new safety labeling about the age of users, they will also get new labels about safe use in general, said the FDA. Common side effects of opioids include headache, dizziness and vomiting. If a cough medicine is prescribed, ask your child's health care professional or a pharmacist if it contains an opioid such as codeine or hydrocodone.
A new Contraindication to the tramadol label warning against its use in children younger than 18 years to treat pain after surgery to remove the tonsils and/or adenoids. For those children in whom cough treatment is necessary, alternative medicines are available.
It's always important to read medicine labeling, too - even if it's not obtained by prescription. "If the medicine prescribed for your child contains an opioid, talk to your child's health care professional about a different, non-opioid medicine", it said.