FDA restricts administration of strong pain killers to children

pharmafile | April 21, 2017 | News story | Medical Communications, Sales and Marketing FDA, opioid 

The FDA has announced that it will require medication including codeine and tramadol, two high-strength painkillers, to have its strongest warning on the label. The labels will include the advice against the use of such medication, such as codeine-containing cough syrup, in children under the age of 12 years. Wider than this, the FDA will also suggest that the painkillers only be used in exceptional circumstances in children under the age of 18 and in women who are breastfeeding.

The agency has been assessing the risk of both drugs for over two and a half years. The research found that the painkillers can, in rare examples, cause breathing difficulties and even death. The announcement by the FDA stated: “Our review of several decades of adverse event reports submitted to FDA from January 1969 to May 2015 identified 64 cases of serious breathing problems, including 24 deaths, with codeine-containing medicines in children younger than 18 years. This includes only reports submitted to FDA, so there may be additional cases about which we are unaware. We also identified nine cases of serious breathing problems, including three deaths, with the use of tramadol in children younger than 18 years from January 1969 to March 2016”.

The latest announcement comes even though medication containing the two drugs already contained warnings against use in children but it was widely recognised that off-label prescriptions of the painkillers were still occurring across the country. The FDA hopes that the revised warnings, with statistics to reinforce the risk, will discourage further prescription medicine being used to treat children.

Though objectively unrelated, it is widely acknowledged that North America is in the grip of an opioid crisis. The FDA’s sterner step to limit the use of opioid painkillers, such as codeine and tramadol, is part of a wider effort to research and limit the side-effects of such drugs. Opioids are estimated to cause 63% of drug overdose deaths and, between the years 1999 and 2015, approximately 560,000 have died as a result of overdoses across the US.

Ben Hargreaves

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