FDA Announces New Codeine and Tramadol Restrictions
Pharmacist Ashok Pinnamaraju owns Lexcare Pharmacy in Lexington, Virginia. At this closed-door pharmacy, Ashok Pinnamaraju serves a variety of health care institutions in the Greater Shenandoah Valley area by maintaining superior quality and ensuring regulatory compliance.
In April 2017, the FDA announced new restrictions for the use of certain opioids, including codeine and tramadol. These new guidelines primarily seek to improve safety for young children and infants who are being breastfed.
Under these new restrictions, codeine and tramadol should not be used to manage pain or cough in children under the age of 12. Tramadol labels should also include a warning about use by individuals under the age of 18, particularly after certain surgeries or when those individuals are obese.
The new guidelines also strengthen existing warnings for mothers who are breastfeeding. Codeine and tramadol use by mothers can increase the risk of serious reactions in their nursing infants, and some of these reactions can lead to death. New labels should properly warn consumers of these serious risks.