Warnings About Pediatric Use of Codeine and Tramadol
April 20, 2017 - The U.S. FDA strengthened warnings about pediatric use of codeine and tramadol products in a Drug Safety Communication. Codeine is often used to lessen coughing and pain and can be found in combination with other drugs. In some states, certain codeine-containing medications are sold without a prescription. Tramadol treats pain, but it is indicated only for adults and it is dispensed by prescription-only. Due to a higher risk of potentially severe or even fatal breathing problems associated with their use, neither codeine nor tramadol should be used for patients younger than 12 years of age. Their use also should be very limited for patients between the ages of 12 years and 18 years who are obese or who have breathing disorders, such as sleep apnea. Because both codeine and tramadol are passed to an infant in breast milk, breastfeeding women are warned not to use either one, as well.
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.