In Spain, the Spanish Agency for Medicines and Health Products (AEMPS), dependent on the Ministry of Health, has decided restrict the use of codeine for cough in under 12 years and also during the Breastfeeding because they have been detected relevant risks in certain patients and, in addition, there is scant evidence effectiveness in catarrhal processes. It has also recommended that under 18 years Avoid taking these medications if you have respiratory compromise due to underlying pathologies.
But what is this about now? We tell you in detail and with official recommendations for safe use.
La codeine is a derived from opiumThis opioid is authorized for the symptomatic treatment of mild or moderate pain and the unproductive cough, and was used for years for cough associated with catarrhal processes in pediatric population. Its effect depends on its conversion to morphine by the cytochrome P2 enzyme CYP6D450, a process with great genetic variability.
The investigations
El Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency reviewed the benefit-risk balance of codeine medications in pediatrics after knowing serious cases (including some with fatal outcomes) in children who had suffered morphine poisoning after receiving codeine as a painkiller. In several of these cases, the minors had undergone surgery tonsillectomy or adenoidectomy due to obstructive sleep apnea syndrome, a particularly serious scenario sensitive due to its impact on respiratory function.
The key is that the pharmacological effect of codeine is due to its transformation into morphine by CYP2D6. Some people are ultra-rapid metabolizers, which converts codeine into morphine at a faster rate, reaching elevated concentrations with a higher risk of toxicity. This genetic trait varies with the ethnic origin and there is no such thing as test available in clinical practice for routine use that allows for precise knowledge of each patient's phenotype.
Furthermore, comparative analyses showed that in children, analgesic efficacy of codeine is limited and does not significantly exceed non-opioid analgesics such as paracetamol or ibuprofen when used correctly. Regarding cough associated with catarrhal processes, the PRAC noted that there are scant evidence that supports its benefit in pediatrics, and that the most of these coughs They are processes self-limiting that improve with support measures.
This review prompted a new evaluation focused on the antitussive use of codeine in the pediatric population, concluding that the therapeutic approach chronic cough in children should be preferably etiological (treat the cause) and that, although it can occur at any age, under 12 years present a increased risk of adverse reactions to codeine, especially if they are ultra-rapid metabolizers.
Codeine ban
Although the morphine poisoning It can occur at any age, including children under 12 years they have a higher risk of suffering adverse reactions after the administration of codeine, with particular severity in ultra-rapid metabolizers. This risk also applies to patients, regardless of age, who present respiratory problems as a consequence of other pathologies.
The fact is that the Health Department has decided that the therapeutic treatment of the chronic cough in children should preferably be etiological, and that should restrict the use of codeine in children under 12 years of age and in patients with ultra-rapid metabolizers. In addition, it is also prohibits women during breastfeeding due to the risk of the infant suffering serious adverse reactions if the mother was an ultra-rapid metabolizer.
In addition, the Ministry of Health advises against the use of codeine in patients aged 12 to 18 years to compromised respiratory function (e.g., neuromuscular disorders, severe respiratory or cardiac pathology, pulmonary infections, multiple trauma or after extensive surgical procedures). In the area of ​​pain, codeine is reserved for moderate acute pain in children over 12 years of age when are not suitable other painkillers such as paracetamol or ibuprofen.
- Do not use codeine in children under 12 years of age.
- Do not use en ultra-rapid metabolizers of CYP2D6 (high risk of morphine poisoning).
- Do not use en lactation due to the risk of exposing the baby to high levels of morphine.
- Inadvisable in 12-18 years with respiratory compromise due to underlying diseases or complex post-surgical phases.
- contraindicated en under 18 that are going to be operated on tonsillectomy/adenoidectomy due to obstructive sleep apnea syndrome.
To minimize risks, when codeine is used exceptionally in people over 12 years of age for pain, it is recommended lowest effective dose, with the possibility of distributing it in up to 4 doses per day at intervals not less than 6 hours, and with a maximum duration de 3 daysIf no relief is achieved after this period, you should consult to the healthcare professional.
Currently, information from the Pharmacoepidemiological Research Database in Primary Care (BIFAP) The AEMPS indicates that the use of codeine in children between 2 and 11 years of age is mostly as antitussiveBeing practically non-existent in children under 2 years of age. This pattern reinforces the need for review directions and prioritize alternatives with a security profile more favorable.
It is worth remembering that, beyond codeine, catarrhal cough in childhood is usually self-limiting and can be addressed with General measures (hydration, nasal washing with serum for clear mucus from the throat, keep the environment humid and, in children over one year old, honey with caution), reserving the cough suppressants for very selected situations and always under professional criteria.
If a suspected adverse reaction with codeine (or any medication), it is important notify it to the Spanish Pharmacovigilance System through the portal NotifyRAMHealth professionals and citizens can report Serious or unexpected RAMs, including those due to Interacciones or medication errors. Remember that medication errors additional monitoring They are identified by an inverted black triangle in their information material.
Medicines containing codeine
The most common codeine medications sold in Spain are the following. It is essential read the package leaflet, follow the indications of the professional and take into account the restricciones previous ones for minors and breastfeeding.
codeisan
- Codeine syrup calms or eliminates the moderate pain (analgesic effect) and also calms the cough (antitussive).
- This medicine is used in the short-term treatment of moderate pain in patients over 12 years of age and when other analgesics are not considered adequate, such as paracetamol e ibuprofen.
- It is also used for the symptomatic treatment from cough without secretions, always respecting the contraindications by age and breastfeeding.
Tosein
- It is a cough suppressant, both in acute and chronic respiratory conditions, which allows the suppression of persistent coughing fits, typical of certain diseases of the respiratory system.
- He also owns a moderate analgesic effect y mild sedative, so it should be used with caution in those who present respiratory risk or take other CNS depressant drugs.
Histaverin
- It is a medicine for unproductive cough, dry, irritating cough and nocturnal cough.
- Due to its composition, it should be administered with caution in elderly and debilitated patients with functional disabilities liver, heart or kidney altered, as well as in cases of Hypothyroidism, prostatic hypertrophy, chronic ulcerative colitis and diseases that occur with decreased respiratory capacity.
Beyond these brands, remember that codeine can also appear in combination with other active ingredients (e.g. paracetamol or ibuprofen) for the moderate painIn all cases the following must be applied: same restrictions: not in children under 12 years, avoid in lactation, carefully assess at 12-18 with respiratory compromise and reserve its use when no alternatives are available non-opioids.
The scientific community agrees that the genetic variability of CYP2D6 makes it difficult to anticipate individual response to codeine. Therefore, and given that the conversion to morphine is unpredictable (especially in ultra-rapid metabolizers), regulatory agencies have strengthened the safety warnings and the contents of the prospectus, promoting a more prudent and selective use of this opioid in the pediatric population and in special situations such as lactation.
If you have any doubts about whether codeine is suitable for you, always consult your doctor. pediatrician o family doctor. Cough due to catarrh usually resolves on its own, and treatment is focused on the cause and in support measures it is usually the most Safety and effective. Reporting any suspected adverse reactions helps to improve the to maximise security and your enjoyment. of all.
