FDA putting new limits on cold medicine for children

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New safety labeling requirements about who should take prescription opioid cough and cold medicines with codeine or hydrocodone are due to roll out following a United States Food and Drug Administration announcement.

The FDA announced yesterday that it is requiring revisions to the safety labeling on such perscription opioid cough and cold medicines. The panel declared that the risks of using certain opioids in children's cough medications outweigh the benefits.

The agency said it is requiring manufacturers to change the wording on their labels to make clear that such products should not be used for anyone younger than 18.

"Given the epidemic of opioid addiction, we're concerned about unnecessary exposure to opioids, especially in young children".

Labeling for these medications will also be updated with additional safety information for adults, including an expanded boxed warning. These medicines carry serious risks, including slowed or hard breathing and death, which appear to be a greater risk in children younger than 12 years, and should not be used in these children. "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".

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The FDA will also carry bigger warning about their dangers to adults, NBC News reported.

These requirements made on Thursday pertain to medicines containing codeine or hydrocodone in children younger than 18-years-old. Cough and cold medicines that have opioid ingredients, such as codeine or hydrocodone, should no longer be given to children of any age.

Common side effects of extended opioid use include drowsiness, dizziness, nausea, vomiting, constipation, shortness of breath and headache.

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. Cough is often secondary to infection, not serious, and usually will get better on its own so treatment may not be necessary.

It's always important to read medicine labeling, too - even if it's not obtained by prescription. 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. 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.

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