FDA Updates Safety Communication for Opioid Cough Medicines

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Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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On January 11th, the FDA issued a drug safety communication for certain prescription cough and cold medications that contain codeine or hydrocodone.

Many prescription medications are to blame for our current opioid epidemic, especially in our adolescents and teens. Therefore, limiting the prescribing of unnecessary medications to children under 18 years of age is particularly important.

What is the significance of this safety communication?

The significance of this safety communication is that the benefit of a prescription cough and cold medications containing codeine or hydrocodone no longer outweigh the serious risks associated with their use. Especially in children less than 18 years of age.

See the FDA Drug Safety Communication for a list of cough and cold medicines that contain codeine or hydrocodone.

Are there alternatives for those under 18 years of age?

Yes.  Most coughs from the common cold will actually go away on their own and do not require treatment. However, if treatment is required, several over-the-counter medications that contain dextromethorphan can be used for symptom management.  

There are also other non-opioid prescription medications that may be used if your doctor feels as though treatment is necessary.

What is being done to warn people about these serious side effects?

The FDA is requiring safety labeling changes for all prescription cough and cold medications that contain codeine or hydrocodone.  

The FDA is also requiring the addition of safety information about the risks of misuse, abuse, addiction, overdose, death, and slowed or difficult breathing to the boxed warning the strictest warning given to a medication by the FDA.

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