Laporte, Joan Ramon

English

Biblioteca Digital de la Universidad del Valle

250Colombia Médica                  Vol. 40 Nº 3, 2009 (Julio-Septiembre)Possibly still are health professionals that whenhearing about adverse drug reactions only think incutaneous rash, blood dyscrasias, anaphylactic shockand congenital malformations. The mentioned adverseeffects are real, but relatively infrequent. Furthermore,are unexpected, not related with the pharmacologicalmechanism of action, unpredictable and dose independent.These adverse drug reactions are like a therapeuticlottery, depending on «luck».However, when the pharmacological pathologyresulting in medical care is analyzed, the perspective isvery different. For instance, the predominant adversedrug reactions in emergency wards are those related withthe pharmacological mechanism of action: severehemorrhage due to anticoagulant and antiplatelet drugs;renal insufficiency and hyperkalemia by inhibitors of therenin-angiotensin axis; hyponatremia, fells and fractu-res by SSRI antidepressants, digitalis intoxication…These are relatively common pathologies, expectable,dose-related, and favored by patient comorbidity,preventable in many cases if the dose would havecarefully individualized, if the patient complied betterwith the instructions (in case the patient understood theinformation) or if a more carefully clinical surveillancewere performed.A review of the literature reminds us other pathologiesattended in other assistance levels, for example:- Breast cancer attributable to the hormone replacementtherapy (HRT): three to four additional cases per1.000 women treated during 5 years, this is translatedin thousands of additional cases of breast canceraccording to the sales data of these products betweenthe years 1993 to 2003. Moreover, it was irresponsiblypromoted for the prevention of cardiovascular events,dementia, and as the source of eternal youth withoutproven efficacy at that time (no evidence of efficacyexist today).- Non-steroidal anti-inflammatory drugs (NSAIDs) -especially celecoxib and diclofenac -increase the riskof acute myocardial infarct in 50-70%, because theirhigh consumption by elderly people, these drugs areassociated with a considerable number of deaths bymyocardial infarct.- Proton pump inhibitors, SSRI antidepressants,benzodiacepines, and antipsychotics are the causethousands of cases of femoral neck fracture in elderlypeople.- High dose of erythropoietin (to achieve a level of 12g/dL of hemoglobin or more) increase the mortality in25%, therefore, one additional death is induced bythe treatment of four patients.The previous adverse reactions are only someexamples. The list is very long, covering all medical andsurgical specialties, and practically any pathology: Forinstance, obesity and parkinsonism by antipsychoticsand prokinetics, increase in the risk of suicide by the useof SSRI antidepressants in children’s and antiepilepticagents in adults (frequently in no approved indications),stroke and death secondary to antipsychotics, respiratorydepression by fentanyl and opiate derivatives, trafficaccidents by CNS depressants, cancer by immuno-suppressive agents, resistant and opportunisticnosocomial infections secondary to broad spectrumantibiotics, fractures by thiazolidinediones, cancer byezetimibe… In some highly specialized areas we shouldrecognize that we know almost nothing; for instancelet’s reflect on the safety of the new and old antineoplasticchemotherapeutic agents in real practice.Studies on the usage of medicaments unequivocallyindicate that many drugs are unnecessary consumed bypeople, as well as the opposite, many people needing themedication do not consume it by lack of access or otherreasons. Both situations originate an unnecessary andpreventable pathology. An important part of the iatrogenicpathology that affects the population might be theconsequence of the non-rational prescription of unneededdrugs or the prescription of medicaments that are not thefirst choice. A particular concern is the pressure for theprescription of new drugs, patent protected, moreexpensive, not even directly compared in RandomizedClinical Trials with already available agents. RememberVioxx®: New drugs are associated with major uncertaintyregarding their safety.The influence of commercial promotion on drugEDITORIALADVERSE DRUG REACTIONS:A MULTIFORM PATHOLOGY RESPONSABILITY OF MANY© 2009 Universidad del Valle, Facultad de Salud                                         Colomb Med. 2009; 40: 250-1251Colombia Médica                        Vol. 40 Nº 3, 2009 (Julio-Septiembre)prescription is undeniable: It is necessary to rememberthat commercial innovation is not equivalent totherapeutic innovation, meaning that increased efficacyequals additional safety, more comfort and improved lifequality for our patients. The only truth is that newtherapeutic agents are more expensive compared towell-known alternatives with more experience of usage.Rational, reflexive and prudent prescription of drugsis not only a physician responsibility. Health care systemsand health insurers have the responsibility to providecontinuous formation to their workers with independencefrom the pharmaceutical industry, along with thefacilitation of medical practice by the means of selectingthe best alternatives for each health related problem,allowing more focus to manage the knowledge ofproblems that are really essential.Joan-Ramon LaporteFundació Institut Català de FarmacologiaUniversitat Autònoma de Barcelona.Servicio de Farmacología Clínica, Hospital Valld’Hebron, Barcelona. e-mail: jrl@icf.uab.es

Adverse drug reactions: a multiform pathology responsability of many.

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