FDA Orders Labeling Changes For Certain Cough And Cold Medicines


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. "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", said FDA Commissioner Scott Gottlieb, M.D.

The FDA also said it is requiring manufacturers to add new safety warnings for adult use - including an expanded box warning, the most prominent kind - spelling out the risks of using medications with codeine and hydrocodone.

Codeine and hydrocodone are available in combination with other medicines, such as antihistamines and decongestants, in prescription medicines to treat coughs and symptoms associated with allergies or the common cold.

According to the FDA, labeling for adult-only use of prescription opioid cough and cold medicines that contain codeine or hydrocodone will also now include updated safety information.

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These medicines should only be used for adults 18 and older. "It's critical that we protect children from unnecessary exposure to prescription cough medicines containing codeine or hydrocodone".

The changes in the labeling requirements were decided upon after extensive research on the topic and the safety risks, including advice from experts, said the release from the FDA. These products will no longer be indicated for use in children, and their use in this age group is not recommended. These new actions further limit the use of these medicines beyond the 2013 FDA restriction of codeine 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. "We know that some children and teens may, in fact, develop a predilection for the "high" the prescription cough syrups deliver, and subsequently attempt to deceive parents and health care providers regarding the severity of their symptoms to obtain such a prescription".

Parents and caregivers should be aware that prescription opioid cough and cold medicines that include codeine or hydrocodone should not be used in children. Always read the labels on prescription bottles.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.