On Thursday, April 20th, the FDA issued a statement announcing a number of changes that are being made to the labeling requirements for two opioids – codeine and tramadol. The Agency’s statement notes that both products are found in various prescription pain medications; additionally, codeine can also be found in some prescription and over-the-counter (OTC) cough medications.
Serious side effects are associated with the use of both codeine and tramadol, including slowed or difficulty breathing and even death. FDA states that these risks are increased in children under 12 years of age, which is the reason behind the labeling changes being mandated. Furthermore, FDA states that the health and safety of children is a top priority of the Agency, and notes that it is making these changes “to help better protect children from serious risks associated with these medicines.”
In 2013, “FDA added a Boxed Warning to the codeine drug label cautioning against prescribing codeine to children of any age to treat pain after surgery to remove tonsils or adenoids.” In July 2015 and September 2015, the Agency issued Drug Safety Communications, warning consumers of the risk of serious breathing problems experienced by some children who metabolized codeine and tramadol much faster to their active form than usual. This increased digestion is called ultra-rapid metabolism, and has the potential to cause dangerously high levels of the substance in the bodies of children too quickly.
In addition to the previous restrictions placed on the substance, the following are now being added:
FDA’s recent Drug Safety Communication states that the Agency will continue to monitor this safety issue. Furthermore, it notes that the Agency is considering pursuing “additional regulatory action for the OTC codeine products that are available in some states. OTC codeine products are available in combination with other medicines for cough and cold symptoms.”
May 4, 2016
Additional information on FDA's draft guidance is available in our preceding FDA News article, entitled "FDA Guidelines for Post-Approval CMC Changes, Part One: Overview of the Updated Draft...
May 3, 2016
On April 19, 2016, FDA released a revised and updated draft guidance entitled "Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information," which...
October 22, 2015
On March 3, 2014, FDA announced a proposed rule that would amend the regulations regarding the labeling of conventional foods and dietary supplements. In this announcement, the Agency sought feedback...