| What are cutaneous adverse drug reactions (cADR)? | undesirable clinical manifestations to a drug, which include predictable or unanticipated side effects, with or without systemic involvement | July/ 2022 Cutaneous adverse drug reactions (cADR) are undesirable clinical manifestations to a drug, which include predictable or unanticipated side effects, with or without systemic involvement Standard Treatment Workflow (STW) CUTANEOUS ADVERSE DRUG REACTIONS- PART A | 55 | definition | 0.980 | https://www.icmr.gov.in/icmrobject/uploads/STWs/1725967367_cutaneous_part_a.pdf | July/ 2022 Cutaneous adverse drug reactions (cADR) are undesirable clinical manifestations to a drug, which include predictable or unanticipated side effects, with or without systemic involvement Standard Treatment Workflow (STW) CUTANEOUS ADVERSE DRUG REACTIONS- PART A | 1 | page=1,block=26 | 0.700 | valid |
| What is a common presentation of the described allergic reaction? | Sudden onset of an itchy rash that is symmetrically distributed and spreads rapidly | all drugs should be kept in suspect list • Concomitant viral infection or illnesses affecting drug metabolism or excretion (eg. chronic kidney disease) • Common presentation: Sudden onset of an itchy rash that is symmetrically distributed and spreads rapidly. May have had a previous similar allergic reaction. • Withdraw: The offending drug(s) immediately, except life saving drugs (if they are not the suspected drugs) • Take necessary measures to prevent similar events (record on patient’s medical chart, educate, provide allergy card etc.) • Recognize danger signs » Mucosal lesions, purpuric lesions, skin tenderness, bullous lesions (peeling/ sloughing of skin) » Systemic symptoms: High grade fever, jaundice, decreased urine output • Action required: Prompt and urgent care at a specialised centre. | 175 | summary | 0.970 | https://www.icmr.gov.in/icmrobject/uploads/STWs/1725967367_cutaneous_part_a.pdf | chronic kidney disease) • Common presentation: Sudden onset of an itchy rash that is symmetrically distributed and spreads rapidly. | 1 | page=1,block=16 |
| What is a limitation of the patch test in severe cutaneous adverse drug reactions? | has a low sensitivty and should not be relied upon in severe cADR | Provocation is pre- ferred with a chemically unrelated molecule • Intradermal tests can be done in IgE mediated reactions • Patch test has a low sensitivty and should not be relied upon in severe cADR NON- SEVERE cADR Maculopapular/ Exanthematous reactions Fixed drug eruption | 135 | summary | 0.970 | https://www.icmr.gov.in/icmrobject/uploads/STWs/1725967367_cutaneous_part_a.pdf | Provocation is pre- ferred with a chemically unrelated molecule • Intradermal tests can be done in IgE mediated reactions • Patch test has a low sensitivty and should not be relied upon in severe cADR NON- SEVERE cADR Maculopapular/ Exanthematous reactions Fixed drug eruption | 1 | page=1,block=32 | 0.700 | valid |
| What is the typical progression pattern of an erythematous maculopapular eruption? | Typically starts on the trunk, spreads symmetrically to extremities | SECONDARY LEVEL CARE • Continue treatment as described at primary care level • If severe: add short course of oral steroids: Prednisolone 0.5 mg-1 mg/kg for 3-5 days • Abrupt onset, erythematous maculopapular eruption • Typically starts on the trunk, spreads symmetrically to extremities. Dependent areas may have purpuric lesions • Usually accompanied by mild systemic symptoms- pruritus, low grade fever, mild eosinophilia • All drugs taken in the last 4 weeks are suspects. | 220 | summary | 0.970 | https://www.icmr.gov.in/icmrobject/uploads/STWs/1725967367_cutaneous_part_a.pdf | SECONDARY LEVEL CARE • Continue treatment as described at primary care level • If severe: add short course of oral steroids: Prednisolone 0.5 mg-1 mg/kg for 3-5 days • Abrupt onset, erythematous maculopapular eruption • Typically starts on the trunk, spreads symmetrically to extremities. | 1 | page=1,block=16 | 0.700 | valid |
| What are examples of non-severe cutaneous adverse drug reactions? | Maculopapular/ Exanthematous reactions Fixed drug eruption | Provocation is pre- ferred with a chemically unrelated molecule • Intradermal tests can be done in IgE mediated reactions • Patch test has a low sensitivty and should not be relied upon in severe cADR NON- SEVERE cADR Maculopapular/ Exanthematous reactions Fixed drug eruption | 218 | list | 0.820 | https://www.icmr.gov.in/icmrobject/uploads/STWs/1725967367_cutaneous_part_a.pdf | Provocation is pre- ferred with a chemically unrelated molecule • Intradermal tests can be done in IgE mediated reactions • Patch test has a low sensitivty and should not be relied upon in severe cADR NON- SEVERE cADR Maculopapular/ Exanthematous reactions Fixed drug eruption | 1 | page=1,block=32 | 0.700 | valid |
| What are examples of severe cutaneous adverse drug reactions? | Angioedema/ Anaphylaxis* Drug induced hypersensitivity syndrome/ DRESS* Erythema multiforme/ Stevens Johnson syndrome/ Toxic epidermal necrolysis* Acute generalized exanthematous pustulosis FDE BULLOUS FDE MACULOPAPULAR RASH | SEVERE cADR Angioedema/ Anaphylaxis* Drug induced hypersensitivity syndrome/ DRESS* Erythema multiforme/ Stevens Johnson syndrome/ Toxic epidermal necrolysis* Acute generalized exanthematous pustulosis FDE BULLOUS FDE MACULOPAPULAR RASH | 12 | list | 0.820 | https://www.icmr.gov.in/icmrobject/uploads/STWs/1725967367_cutaneous_part_a.pdf | SEVERE cADR Angioedema/ Anaphylaxis* Drug induced hypersensitivity syndrome/ DRESS* Erythema multiforme/ Stevens Johnson syndrome/ Toxic epidermal necrolysis* Acute generalized exanthematous pustulosis FDE BULLOUS FDE MACULOPAPULAR RASH | 1 | page=1,block=47 | 0.700 | valid |
| What are some common drugs that cause fixed drug eruption (FDE)? | Sulfonamides, tetracyclines, quinolones, NSAIDS, dapsone, antimalarials, barbiturates, nitroimidazoles | Resolve with persistent hyperpigmentation • Clinical variants: bullous, generalised, pure mucosal • Common drugs that cause FDE: Sulfonamides, tetracyclines, quinolones, NSAIDS, dapsone, antimalarials, barbiturates, nitroimidazoles | 129 | list | 0.820 | https://www.icmr.gov.in/icmrobject/uploads/STWs/1725967367_cutaneous_part_a.pdf | Resolve with persistent hyperpigmentation • Clinical variants: bullous, generalised, pure mucosal • Common drugs that cause FDE: Sulfonamides, tetracyclines, quinolones, NSAIDS, dapsone, antimalarials, barbiturates, nitroimidazoles | 1 | page=1,block=16 | 0.700 | valid |
| What are some danger signs that require prompt and urgent care at a specialised centre? | Mucosal lesions, purpuric lesions, skin tenderness, bullous lesions (peeling/ sloughing of skin) | all drugs should be kept in suspect list • Concomitant viral infection or illnesses affecting drug metabolism or excretion (eg. chronic kidney disease) • Common presentation: Sudden onset of an itchy rash that is symmetrically distributed and spreads rapidly. May have had a previous similar allergic reaction. • Withdraw: The offending drug(s) immediately, except life saving drugs (if they are not the suspected drugs) • Take necessary measures to prevent similar events (record on patient’s medical chart, educate, provide allergy card etc.) • Recognize danger signs » Mucosal lesions, purpuric lesions, skin tenderness, bullous lesions (peeling/ sloughing of skin) » Systemic symptoms: High grade fever, jaundice, decreased urine output • Action required: Prompt and urgent care at a specialised centre. | 572 | list | 0.820 | https://www.icmr.gov.in/icmrobject/uploads/STWs/1725967367_cutaneous_part_a.pdf | • Withdraw: The offending drug(s) immediately, except life saving drugs (if they are not the suspected drugs) • Take necessary measures to prevent similar events (record on patient’s medical chart, educate, provide allergy card etc.) • Recognize danger signs » Mucosal lesions, purpuric lesions, skin tenderness, bullous lesions (peeling/ sloughing of skin) » Systemic symptoms: High grade fever, jaundice, decreased urine output • Action required: Prompt and urgent care at a specialised centre. |
| What factors determine the dose of drug for a challenge? | the severity of the previous reaction and the pharmacokinetic profile | In the absence of any reliable in vitro test in clinical setting, oral drug challenge is the only way to detect the responsible drug Usually undertaken when drug avoidance is impractical, especially in case of polypharmacy or life saving medicines (e.g. antituberculous therapy) • Take a written consent prior to challenge • Contraindicated in active illness or pregnancy • Assess the risk benefit ratio • Caution: patients on antihistamines, oral steroids and tricy- clic antidepressants may have a modified response to the challenge • A negative test only indicates that the patient is not allergic to the drug at the time of challenge • The dose of drug for challenge depends on the severity of the previous reaction and the pharmacokinetic profile • Drug provocation should always be done - After admission/ under observation except in cases with FDE - Usually in the daytime so that the faintest erythema is appreciated - It should be treated immediately and aggressively with an appropriate dose of systemic corticosteroid which may be required for only 1-2 days - Drug provocation in cases with DRESS has to be avoided or if provoked, a prolonged retreatment is required - In case of SJS-TEN drug provocation should be done only if the drug cannot be avoided. | 682 | list |
| What laboratory tests are recommended at secondary care for red flag signs? | CBC (Eosinophilia supports the diagnosis), LFT, serum creatinine, urine M/E | RED FLAG SIGNS • Mucosal involvement • Purpuric lesions • Bullous lesions • Skin tenderness • Facial/ acral edema • Erythroderma • Systemic symptoms - High grade fever, hepatitis, renal involvement, significant eosinophilia PRIMARY CARE • Withdraw the suspect drug(s) • Pheniramine maleate 25 mg TID • Calamine lotion • Refer to higher center if symptoms persist or red flag signs present SECONDARY CARE • Confirm the diagnosis by history and clinical findings • Admit if red flag signs are present • Laboratory tests: CBC (Eosinophilia supports the diagnosis), LFT, serum creatinine, urine M/E • Treatment: in severe cases, prednisolone 0.5-1 mg/ kg/ day x 5-7 days (after ruling out infection) TERTIARY CARE • Admit if red flag signs are present • Confirm diagnosis of drug rash • Additional lab tests if required: ANA, HIV, skin biopsy • Consider DRESS if rash is progressing or significant organ involvement is evident | 519 | list | 0.820 | https://www.icmr.gov.in/icmrobject/uploads/STWs/1725967367_cutaneous_part_a.pdf | RED FLAG SIGNS • Mucosal involvement • Purpuric lesions • Bullous lesions • Skin tenderness • Facial/ acral edema • Erythroderma • Systemic symptoms - High grade fever, hepatitis, renal involvement, significant eosinophilia PRIMARY CARE • Withdraw the suspect drug(s) • Pheniramine maleate 25 mg TID • Calamine lotion • Refer to higher center if symptoms persist or red flag signs present SECONDARY CARE • Confirm the diagnosis by history and clinical findings • Admit if red flag signs are present • Laboratory tests: CBC (Eosinophilia supports the diagnosis), LFT, serum creatinine, urine M/E • |