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Department of Dermatology, Venereology and Allergology, St. Drug hypersensitivity reactions are unpredictable adverse drug reactions.
They manifest either within 1—6 h following drug intake immediate reactions with mild to life-threatening symptoms of anaphylaxis, or several hours to days later delayed reactions , primarily as exanthematous eruptions. It is not always possible to detect involvement of the immune system allergy. Waiving diagnostic tests can result in severe reactions on renewed exposure on the one hand, and to unjustified treatment restrictions on the other. With this guideline, experts from various specialist societies and institutions have formulated recommendations and an algorithm for the diagnosis of allergies.
Where possible, the objective is to perform allergy diagnostics within 4 weeks—6 months following the reaction. A clinical classification of symptoms based on the morphology and time course of the reaction is required in order to plan a diagnostic work-up. However, skin and laboratory tests are often negative or insufficiently reliable.
In such cases, controlled provocation testing is required to clarify drug reactions. This method is reliable and safe when attention is paid to indications and contraindications and performed under appropriate medical supervision. Whilst type-A adverse drug reactions ADR are caused by known pharmacological or toxic reactions, hypersensitivity drug reactions are caused by individual predisposing factors in the patient and are essentially unpredictable type-B reactions [ 1 ].
Drug allergy is distinct from a non-immunological drug hypersensitivity reaction Tab. Dispensing with a diagnostic work-up can result in severe reactions on renewed exposure on the one hand, and to unjustified restrictions in terms of treatment options on the other.
Following constitutive meetings on 11 October and 5 September , K. Merk compiled a draft version of the new guideline by updating and revising the existing guideline [ 2 ]. At a consensus conference held on 15 April , each recommendation was discussed and agreed on in a structured consensus-finding process under neutral moderation in order to solve open decision-making problems and to provide a final assessment of the recommendations.
This guideline is addressed to all physicians, as well as other professionals working in the medical field, involved in the diagnosis of and counseling on drug hypersensitivity reactions in patients of all age groups.
The general principles of clarifying drug hypersensitivity reactions are presented. It is beyond the scope of this guideline to provide details on diagnostic methods or specific procedures in the case of hypersensitivity reactions to individual drugs or drug groups, or on rare diseases induced by drug hypersensitivity.
Definitions for the classification of ADR are given in Tab. Diagnostic allergy tests are only useful in allergic or non-allergic hypersensitivity reactions, not, however, in pharmacological or toxic ADR. Clinical classification on the basis of morphology, chronology, and time course is helpful for further diagnostic planning and permits the differentiation of hypersensitivity reactions based on the time course Tab.
Investigations should be performed by an experienced allergist or at a specialized allergy center. Knowledge of drugs that frequently elicit specific hypersensitivity reactions is essential for diagnostic planning in order to be able to assess the likelihood with which a drug has caused a reaction.
Patient history as well as skin, in vitro, and provocation tests are used to identify the trigger. A precise description and classification of the original reaction is of utmost importance.
Any diagnostic work-up should take into consideration the particular features of the individual case as well as the diagnostic options available Fig. Every effort should be made to perform diagnostic allergy testing within 4 weeks—6 months after the resolution of symptoms.
There is evidence that successful detection of hypersensitivity several years after the reaction is less frequent [ 5 , 6 ]. The diagnostic success rate is higher in patients presenting during the acute phase of a reaction, since it is possible at that point to establish differential diagnoses, classify clinical manifestations, and reliably interpret the course of symptoms in relation to drug use.
Creating a timeline diagram is recommended in cases where multiple drugs are taken. Typical time intervals between first drug intake and symptom onset are shown in Tab. Although information provided by the patient, as well as all available medical records relating to the reaction e.
A standardized questionnaire to collect relevant information is available [ 8 , 9 ]. A test plan is formulated on the basis of all available information. In maculopapular drug eruptions, reaction typically seen after 1—4 days, typical time interval for repeat reactions has not been investigated in AGEP, SJS, TEN, and DRESS; b mostly 1—2 days with antibiotics, often 7—12 days with other medications; c sometimes longer with allopurinol.
Diagnosis and pathophysiological classification of the clinical reaction taking into account see Tab. In the case of multiple reactions information is required for each individual reaction. Skin tests are carried out in the context of hypersensitivity reactions involving symptoms consistent with allergy in order to determine a sensitization [ 10 , 11 ]. As yet, there is no uniform standard for skin testing with drugs.
In cases where provocation tests are not possible, e. However, diagnostically useful skin test reactions occur only in some patients with hypersensitivity reactions. Test substances in high concentrations can cause reactions even in healthy individuals. It is essential that non-irritant test concentrations are used. However, for many drugs optimal test concentrations are not known.
Recommendations on a number of drugs have been developed recently; examples are given in Tab. Where appropriate, natural rubber latex allergy should be excluded. In extremely rare cases, skin testing with the trigger of a hypersensitivity reaction can cause systemic, occasionally life-threatening reactions.
The physician performing the skin test, as well as nursing staff must be prepared to deal with potential emergency situations [ 11 , 15 , 16 , 17 ]. De novo sensitization as a result of skin testing is possible, whereby this risk depends on the substance tested, its concentration, and the test method used. Therefore, intradermal tests and patch tests should only be performed with the drug suspected of triggering a reaction or relevant alternatives.
The indication for skin testing with non-standardized substances must be established according to particularly strict criteria. Tests with incremental increases in the test substance concentration threshold tests, e. Skin test reactions can occur at other points in time, sometimes also after more than 1 week.
Patients need to be informed that, in such cases, they should seek immediate medical advice from the treating physician.
Tests to measure specific immunoglobulin E IgE antibodies to various drugs are available Tab. Although cellular tests are sometimes helpful, they are only available at a limited number of centers and can cause problems in early childhood due to the large volumes of blood required [ 20 , 21 ]. CE certification requires at least five, the US Food and Drug Administration FDA at least 30 positive patient sera, as well as studies on stability and reproducibility.
Where these criteria have not been fulfilled, test reagents are offered for research purposes where appropriate. Particular attention should be paid here to the quality of the available literature. Determination of sIgE against substances for which no IgE-mediated allergic reactions have been described as yet should not be performed in routine diagnostics. Provocation tests are indicated when the drug triggering hypersensitivity cannot be identified with sufficient reliability on the basis of history, skin testing, and in vitro investigations and when the benefit of information obtained from prvovocation testing outweighs the risks [ 22 ].
This is often the case. Particularly in the case of suspected reactions to substances in drug groups that are essential or that cannot be permanently avoided e. Drug provocation testing is indicated for the purposes of [ 22 ]:. The patient should be informed about the goal of diagnostic testing, the risks involved, the alternatives, as well as the test procedure, including the use of placebo. Informed consent should be given in writing. Medical supervision during the follow-up period, with the possibility of providing prompt intensive medical care if required, should be maintained for as long as severe reactions e.
For this reason, provocation tests likely to cause systemic reactions should be performed in an in-patient setting equipped to provide immediate emergency care experienced medical and nursing staff, appropriate drugs and technical equipment. Determining the procedure of drug provocation testing should always remain a case-by-case medical decision that takes numerous individual factors into consideration e.
The basic principle of provocation testing is to administer substances in the form in which they caused hypersensitivity reactions in the past. Oral administration can be attempted with some substances, even though a different mode of administration was originally used e. As a basic rule, in-patient provocation tests should be performed in a placebo-controlled manner, since a large number of reactions are also seen with placebo tests.
When investigating reactions to some drugs e. It is essential that drugs and medical equipment required for emergency treatment is available and that personnel are experienced in the management of acute emergencies. A negative provocation test does not reliably exclude hypersensitivity. In particular, effects exerted by the disease originally treated e. A reduction in the degree of sensitivity over time can be expected with allergic reactions that lie far in the past.
Therefore, in the case of a long interval between a reaction and testing, re-provocation testing after 4—6 weeks may be considered. The following contraindications exist for tests with suspected culprit drugs, as well as for tests with alternative preparations where cross-reactivity is assumed. In specific cases e. An individual risk-benefit assessment is essential in all cases. The final assessment of findings needs to be made by taking not only results from skin, in vitro, and provocations tests but also, more particularly, the history of the clinical reaction into consideration.
Although drug hypersensitivity cannot be reliably ruled out even by applying all available test methods, they do makeenable better risk assessment easier. The result of the overall assessment is discussed with the patient and documented. Ideally, an allergy passport is issued, representing a medical document. Information on possible drug prophylaxis against hypersensitivity reactions e.
Guideline for the diagnosis of drug hypersensitivity reactions. Allergo J Int ; National Center for Biotechnology Information , U. Published online May 9. This article has been cited by other articles in PMC. Abstract Drug hypersensitivity reactions are unpredictable adverse drug reactions. Introduction Whilst type-A adverse drug reactions ADR are caused by known pharmacological or toxic reactions, hypersensitivity drug reactions are caused by individual predisposing factors in the patient and are essentially unpredictable type-B reactions [ 1 ].
Hypersensitivity is based on an immunological reaction types I—IV according to Coombs and Gell Non-immunological drug hypersensitivity: An immunological allergic reaction mechanism cannot be detected. This form of reaction was formerly further subdivided into: Symptoms differ from the pharmacological effect of the substance.
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