Products covered by Thursday's announcement included four with codeine, in combination with other agents such as chorpheniramine and promethazine, and five with hydrocodone along with other ingredients. The contraindication - FDA's strongest warning - alerted patients that codeine should not be used to treat pain or cough in children younger than 12 years old, due to ultra-rapid metabolism being reported in patients.
The US Food and Drug Administration (FDA) has announced safety labeling changes that will limit the availability of prescription opioid cough and cold medicines for patients younger than 18 years old. Most upper respiratory infections are caused by viruses, and with the exception of influenza, there aren't any drugs that work against viral respiratory infections. As the age range has been changed for prescription opioid cough/cold products with this action, the FDA is recommending that healthcare professionals provide alternative treatments for children (ie, dextromethorphan, prescription benzonatate) when treatment of cough is necessary.
"It's critical that we protect children from unnecessary exposure to prescription cough medicines containing codeine or hydrocodone", he added. "Moreover, the risks of using prescription opioid cough products in children of all ages generally outweigh the potential benefits".
They go much further than the 2017 labeling rules - restricting use of codeine-containing products to everyone under the age of 18, and including cough-and-cold products that contain a second drug, the opioid oxycodone.
The agency urged parents to read the labels on prescription bottles.
Common adverse effects of opioid therapies include drowsiness, dizziness, nausea, vomiting, constipation, shortness of breath and headache, according to the FDA. While today's action was meant to address prescription opioid cough/cold medications, the FDA is considering regulatory action for these OTC products as well. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.