Updated Precautions for Opioid Cough and Cold Medications
January 11, 2018 – The U.S. FDA has updated its requirements for safety labeling on prescription cough and cold medicines that contain either codeine or hydrocodone. According to the new safety labeling, these products should only be used by patients 18 years of age and older. The FDA has determined that the risks to patients under the age of 18 outweigh the potential benefits of such medications.
In addition, the FDA is requiring that prescription cough and cold medicines containing codeine or hydrocodone include a black box warning—the FDA’s strongest—indicating that these medicines carry a risk of misuse, abuse, addiction, overdose, death, and slowed or difficult breathing.
The FDA advises healthcare providers to take note that prescription cough and cold medicines containing codeine and hydrocodone should not be used in patients under the age of 18. Healthcare providers are encouraged to help patients understand that a cough caused by the common cold does not typically require treatment. In the event that treatment is required, the FDA recommends the use of either prescription benzonatate products, or over-the-counter (OTC) non-opioid cough medicines.
Certain states do allow the purchase of cough medicines containing codeine over the counter. The FDA has indicated that it will consider taking regulatory action focused on these products.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.