The website of the Food and Drug Administration (FDA) of the United States released a message, announcing that according to the results of a comprehensive evaluation and external expert consultation, the instructions of opioid cold and cough prescription drugs should be revised. Both this assessment and the expert meeting confirmed that in patients under the age of 18, the risk of respiratory retardation or difficulty, misuse, abuse, addiction, overdose and death caused by such drugs outweighed its benefits.
Prescription drugs containing codeine and hydrocodone can be used in combination with other drugs such as antihistamines and nasal decongestants to treat cough and symptoms related to allergies or the common cold. Other non-opioid prescription drugs and OTC drugs can also treat the above symptoms.
The FDA requires that the safety information of prescription drugs for opioid cold and cough containing codeine or hydrocodone be revised to limit the use of these products only to adults aged 18 and over. At the same time, FDA requires that the safety information about misuse, abuse, addiction, overdose, death and respiratory retardation or difficulty of such drugs be added to the black box warning of the instructions in the most eye-catching way. For the list of cold and cough prescription drugs containing codeine or hydrocodone, please refer to the drug safety newsletter issued by FDA. Some cough drugs containing codeine are OTC drugs in some States of the United States, and FDA is considering taking regulatory measures for these products.
Suggestions for medical staff:
It should be known that the FDA is revising the age range of people who are suitable for opioid cold and cough prescription drugs. These products will not be used in children and are no longer recommended for people under the age of 18. Medical staff should inform parents that cough caused by cold or upper respiratory tract infection is self-limited and usually does not need treatment. For children who must be treated with antitussive therapy, alternative drugs can be used. These drugs include OTC products such as dextromethorphan, and benzoxazole ester prescription drugs.
Suggestions for parents and caregivers of children:
It should be known that children should not be given cold and cough prescription drugs containing codeine or hydrocodone. Codeine or hydrocodone are opioid narcotic drugs, which will bring serious risks to children. It should be understood that cough caused by cold or upper respiratory tract infection usually does not need medical treatment. If cough medicine is a prescription medicine, you should ask the child’s competent medical staff or pharmacist whether the medicine contains opioids such as codeine or hydrocodone. Always read the label on the medicine bottle. If the drugs prescribed for children contain opioid drugs, they should discuss with the competent medical staff of children to replace them with another non-opioid drug; If you have any questions or concerns, you should also ask the competent medical staff.