Breathless cough syrup with codeine is prohibited

Cough syrup with codeine is no longer allowed in children
After long-running debate, the Federal Institute for Drugs and Medical Devices has finally banned cough suppressants containing the cough suppressant codeine for children under the age of 12. Preceded were occurring respiratory depressions in children, which can be life-threatening.
Regardless of respiratory depression, cough suppressants are rarely used. Because the suppression of coughing the body is the defense against infection difficult. Now cough syrup with codeine was banned by the Federal Institute for Drugs and Medical Devices (BfArM) at least for children under the age of 12 years. "The cough medicine codeine CT 5 mg / 5 ml may no longer be dispensed".

Codeine cough syrup is prohibited for children under 12 years. Picture: detail-view-foto - fotolia

Cough syrup with codeine for the treatment of children and adolescents may no longer be placed on the market, according to the latest communication from the Federal Institute for Drugs and Medical Devices (BfArM). "Due to the risk of respiratory depression", a European risk assessment procedure had been carried out for "codeine-containing medicines for the treatment of children and adolescents with cough", the result of which was negative, reports the BfARM.

In view of the results of the risk assessment procedure, inter alia, the treatment of children under the age of 12 with codeine-containing anti-cough medicines was prohibited. The "codeine CT 5 mg / 5 ml, may therefore no longer be placed on the market or given away", reports the BfArM. In addition, liquid drugs containing codeine may in future only be dispensed in child-resistant packaging in order to avoid medication errors and misuse, such as overdoses.

Benefit-risk ratio negatively assessed
According to the BfArM, the reassessment of the risk-benefit ratio for codeine revealed that fatal and life-threatening cases related to codeine occurred in children who were so-called ultrafast metabolizers. In her body, the codeine was converted very quickly into morphine. Due to the high morphine content in the body had serious side effects such as restricted breathing occurred.

Given the lack of rapid tests to check for the existence of a corresponding predisposition, it can not be foreseen how a patient metabolises codeine. The benefit-risk ratio was therefore subsequently stated to be "negative with respect to use in children and adolescents," the BfArM reports. The preparations may no longer be placed on the market, as long as no adaptation of the technical and usage information to the current state of scientific knowledge takes place.

Death related to codeine
In the period from 1978 to 2012, the BfArM stated that "a death was reported for Codeine in childhood". Therefore, a further risk assessment procedure at European level was launched in 2014, which also assesses the benefit-risk profile for the treatment of coughs. Relationship. According to the Federal Institute for Drugs and Medical Devices, the current restrictions are the result of this procedure. (Fp)