FDA Pulls Pediatric Indications For Opioid Cough And Cold Medicines

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Food and Drug Administration on Thursday slapped strict new restrictions on the use of opioid-containing cold and cough products by kids.

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.

"We know that any exposure to opioid drugs can lead to future addiction", Gottlieb said.

The FDA says treating sick children with medicines that contain opioids poses "serious risks that don't justify their use".

"It's critical that we protect children from unnecessary exposure to prescription cough medicines containing codeine or hydrocodone".

The label change also proceeds a pediatric restriction set previous year that required a contraindication to prescription codeine product labels.

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Based on available data and advice reviewed at an expert roundtable and Pediatric Advisory Committee meeting, the FDA determined that the risks of using prescription opioid cough products in children of all ages outweigh the potential benefits.

In 2013, the FDA issued a public warning and implemented a "black box warning" - the strongest safety statement - against prescribing codeine to children for pain management after having their tonsils or adenoids surgically removed. After the labeling changes are made, these products will no longer be indicated for use to treat cough in children and will be labeled for use only in adults aged 18 years and older.

According to the agency, outside experts said that while some children's coughs require treatment, many get better on their own - including ones that are the result of respiratory infections. Common side effects of opioids include headache, dizziness and vomiting.

In a few states, codeine cough medicine is still available for over-the-counter (OTC) dispensing.

The FDA also recommended against the use of these medications by women who are breastfeeding.