Gottlieb also cited the ongoing epidemic of opioid addiction, and stressed the importance of reducing exposure to addictive drugs at a young age.
Common side effects of opioid use include headache, vomiting, dizziness, breathing difficulties and even death.
The changes in the labeling requirements were decided upon after extensive research on the topic and the safety risks, including advice from experts, said the release from the FDA. After the safety labeling changes are made, the products will no longer be indicated for use to treat coughs in any pediatric population. Both are opioids, meaning they're either derived from an opiate or they are synthetic, and are part of a family of narcotic drugs that are highly addictive.
The FDA is also asking companies to add new safety warning labels on medicines for adults, including an expanded boxed warning, which describes the risks of taking those that include codeine and hydrocodone.
Cough and cold medicines containing opioid ingredients, such as codeine or hydrocodone, should no longer be given to children of any age, according to the US Food and Drug Administration. A year ago the restrictions were expanded to include safety labels that carried the contraindication warning, the FDA's most severe warning, to say that it should not be used for patients under the age of 12.
Nisa Investment Advisors LLC Increases Stake in NVIDIA Corporation (NVDA)
The stock presently has an average rating of "Buy" and an average price target of $192.04. (NYSE:MHO) rating on Friday, April 28. It is positive, as 41 investors sold ZTS shares while 233 reduced holdings. 77 funds opened positions while 141 raised stakes.
FDA Commissioner Scott Gottlieb, who has made battling the opioid epidemic a top priority, said in a statement Thursday that it is critical "to protect children from unnecessary exposure" to prescription cough medicines containing codeine or hydrocodone.
Then, last year, the agency warned that the opioids codeine and tramadol could cause life-threatening breathing problems in children and strengthened drug labeling to restrict their use in children younger than 12. And while they say some kids' cough require treatment, symptoms usually subside on their own.
The FDA says treating sick children with medicines that contain opioids poses "serious risks that don't justify their use".
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. If the medicine prescribed for your child contains an opioid, talk to your child's health care professional about a different, non-opioid medicine, or if you have any questions or concerns.
"Caregivers should also read labels on non-prescription cough and cold products", the FDA said, because "some products sold over-the-counter in a few states may contain codeine or may not be appropriate for young children".