The Food and Drug Administration wants health care professionals and patients to report adverse events or side effects stemming from codeine-containing medicine use in people under age 18 years to assist it with a new investigation.
The agency is trying to determine if it is safe for people under 18 years of age to treat coughs and colds with codeine-containing medicines, according to a statement released today. These drugs’ potential for causing slowed or difficult breathing was the impetus for the investigation.
The investigation follows the European Medicine Agency’s announcement, in April 2015, that codeine must not be used to treat cough and cold in children under 12 years, and that codeine use is not recommended for people between the ages of 12 and 18 years who have breathing problems, including those with asthma and other chronic breathing problems. In 2013, the FDA issued a statement warning of the risks of codeine use by children who had recently had surgery to remove their tonsils and/or adenoids.
The FDA “will consider the EMA recommendations” and announce its final conclusions and recommendations after it completes the investigation, said the agency in its recent statement.
Reports on problems with codeine-containing medicines can be submitted online at www.fda.gov.MedWatch/report , by fax (1-800-FDA-0178), or by mail. The FDA’s official reporting forms can be obtained by download or by calling 1-800-332-1088 to request a form.