2 2558

Ambroxol and bromhexine expectorants: safety information to be updated

Co-ordination Group for Mutual Recognition and Decentralized
Procedures-Human (CMDh)
Pharmacovigilance Risk Assessment Committee (PRAC)
Ambroxol and bromhexine
Stevens Johnson syndrome serious cutaneous adverse reactions (SCARs)
Product information
-

- anaphylactic shock, SCARs, erythema multiforme,

Stevens Johnson syndrome, Toxic Epidermal Necrolysis generalized exanthematous
pustolosis ambroxol
- ambroxol metabolite bromhexine

-
Ambroxol and bromhexine
serious
cutaneous adverse reactions (SCARs) PRAC

PRAC Ambroxol and bromhexine

European
Commission

1. Ambroxol
40 urticarial, erythema rash, exfoliative dermatitis
Stevens Johnson syndrome 1
2. bromhexine
149 urticaria, erythema rash
Stevens Johnson syndrome 11 Toxic Epidermal Necrolysis 1

 11 2558
Chantix (varenicline): Drug safety communication-FDA Updates label to include
Potential Alcohol Interaction
US FDA Chantix (varenicline)
alcohol alcohol intoxication aggressive behavior,
amnesia seizures
seizures
agitation, aggressive behavior, depressed mood
suicidal
varenicline
varenicline

US FDA

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Monocytogenes Wegmans Food Markets,Inc
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