Cough and cold medicines that have opioid ingredients, such as codeine or hydrocodone, should no longer be given to children of any age.
As a result, FDA is requiring several changes to the labels of all prescription medicines containing these drugs. 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.
Health care professionals should be aware that FDA is changing the age range for which prescription opioid cough and cold medicines are indicated.
The FDA also said it is requiring manufacturers to add new safety warnings for adult use - including an expanded boxed warning, the most prominent kind - spelling out the risks of using medications with codeine and hydrocodone. "At the same time we're taking steps to help reassure parents that treating the common cough and cold is possible without using opioid-containing products". 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.
Codeine is a pain reliever that is sometimes used in combination with other medications to treat severe cough, according to the FDA.
The new rules announced Thursday were "based on an extensive review of available data and expert advice", the agency said.
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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.
In any case, there's little that can or should be done to ease most children's cough and colds, the FDA said. After the safety labeling changes are made, the products will no longer be indicated for use to treat coughs in any pediatric population.
Though milder side effects include headaches and vomiting, opioids can cause potentially fatal breathing problems, especially in children, the FDA warns.
"It's commendable that the FDA is acting to expand safety use labeling not only for children and teens, but adults as well", said Dr. Robert Glatter, an emergency physician at Lenox Hill Hospital in New York City. Parents of children now prescribed a cough and cold medicine containing codeine or hydrocodone are encouraged to talk to their child's health care professional about other treatment options. For those children in whom cough treatment is necessary, alternative medicines are available.
The agency urged parents to read the labels on prescription bottles.
Parents whose children are now prescribed cold or cough medication containing codeine or hydrocodone are encouraged to talk with their doctors about other treatment options.