FDA Releases New Guidelines for Prescription Cough Medicines

The Food and Drug Administration (FDA) has issued new warnings regarding prescription cough medicines—with the safety of children in mind.

Frequently prescribed for severe cough and cold symptoms, medicines containing hydrocodone and codeine have been placed under a microscope in light of the steadily growing opioid crisis. These two ingredients are classified as opioids, and come with certain risks, even when taken as directed by a physician.

The FDA will now require manufacturing facilities to clearly label products to effectively warn against use by children and teens under the age of 18. A safety warning will also be added to medications containing hydrocodone and codeine for adults, providing education on the dangers of opioid use and misuse.

Of the recent decision, FDA Commissioner Dr. Scott Gottlieb stated that, “Given the epidemic of opioid addiction, we’re concerned about unnecessary exposure to opioids, especially in young children. We know that any exposure to opioid drugs can lead to future addiction. It’s become clear that the use of prescription, opioid-containing medicines to treat cough and cold in children comes with serious risks that don’t justify their use in this vulnerable population.”

The agency notes that side effects associated with the use of these medicines by children (and adults) include, “drowsiness, dizziness, nausea, vomiting, constipation, shortness of breath and headache.”

Families and educators across the country are struggling with the scope of the opioid crisis as it relates to our nation’s children. Many have lost parents, siblings, or friends–or have been exposed to opioids as teens or young adults.

With so many children across the United States affected by opioid use within the family household, it is crucial to take measures toward prevention. Educational programs in the schools, such as those offered in Palm Beach County, are another important step in protecting our nation’s children and paving the way for the health and success of future generations.

While children’s exposure to drugs and alcohol is inevitable, communication and prevention are possible.