The FDA has responded to a number of medical reports about the use of the medications codeine and tramadol in medicines intended for children. With these two drug substances, codeine is approved to treat pain and cough, and tramadol is approved to treat pain.
Codeine is an opioid (narcotic) pain medication. While the drug can be effective at treating pain it does carry side-effects. Common side effects include vomiting, constipation, itchiness, and lightheadedness. Whereas more serious side effects may include breathing difficulties and addiction.
The drug tramadol (more commonly sold under the brand name Ultram) is also an opioid pain medication used to treat moderate to moderately severe pain. More serious side effects relating to the use of the drug include seizures, increased risk of serotonin syndrome, decreased alertness, and drug addiction. Tramadol is a prescription medicine, whereas codeine can be obtained over-the-counter.
The risks appear to be greater risk in children younger than 12 years. For this reason, American Pharmaceutical Review reports, the FDA is clear that the drugs should not be used for children aged 12 and under. This means the position of the FDA is now in line with European inspectors. The FDA adds a warning that the use of these medicines should also be limited in some older children. In other words, single-ingredient codeine and all tramadol-containing products are approved only for use in adults.
With adults, the U.S. health regulator’s warning extends out to include breastfeeding mothers and cautions against women taking the medications when breastfeeding. This is due to the possible risk of the drug transferring from the mother to her infant. Infants can develop excess sleepiness, difficulty breastfeeding, or serious breathing problems that could result in death.
To safeguard consumers, the FDA is requiring pharmaceutical manufacturers to alter the labeling of medicines. This takes the form of the FDA’s strongest warning, which is termed a “contraindication”.
To further build-up data on these opioid products the FDA is asking patients and health care professionals to report any side effects involving codeine and tramadol containing medicines via its MedWatch program.
