Elderly stylish attractive blond woman coughing or sneezing into her hand as she stands on a rural lane on a misty winter day

No More Pediatric Labeling for Codeine or Hydrocodone Cough Syrups

The FDA announced today that they are revising labeling to remove any indication for codeine or hydrocodone-containing cough cold products for use in patient under the age of 18. The FDA Safety Communication (here) states:

“We are taking this action after conducting an extensive review and convening a panel of outside experts.  Both of these determined the risks of slowed or difficult breathing, misuse, abuse, addiction, overdose, and death with these medicines outweigh their benefits in patients younger than 18.”

In addition, FDA also noted that they are adding this safety information to the Boxed Warning for one such products. The Safety Communication also lists those cough and cold products containing either codeine or hydrocodone.  Calming the cough center is important for adults when the cough is non-productive and significantly disrupts sleep and rest, potentially leading the patient to become run down and more susceptible to developing bronchitis or pneumonia.  I am not trying to practice medicine here, just telling it from my perspective as a pharmacist.  Hydrocodone is one of the best cough suppressants, and as I can testify from experience in our family, the only thing that is often able to relieve a non-productive, severe, and persistent cough.  While it should only be used for short term management of severe cough, it can produce “miracle-like” result for certain patients.  Care should be given in the prescribing of such products and only limited quantities should be prescribed.