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U.S. Department of Health and Human Services

Safety

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Neuromuscular Blockers Label Change

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – November 2010

 

Summary View

  • Quelicin (succinylcholine chloride injection, USP)
  • Anectine (succinylcholine chloride injection, USP)
  • Mivacron (mivacurium chloride) Injection
  • Nuromax (doxacurium chloride) Injection
  • Raplon (rapacuronium bromide) Injection
  • Nimbex (cisatracurium besylate) Injection
  • Zemuron (rocuronium bromide) Injection
  • Norcuron (vecuronium bromide) Injection
  • Arduan (pipecuronium bromide) Injection
  • Pavulon (pancuronium bromide) Injection

WARNINGS AND PRECAUTIONS

Anaphylaxis

Severe anaphylactic reactions to neuromuscular blocking agents, have been reported. These reactions have, in some cases, been life threatening and fatal. Due to the potential severity of these reactions, the necessary precautions, such as the immediate availability of appropriate emergency treatment, should be taken. Precautions should also be taken in those patients who have had previous anaphylactic reactions to other neuromuscular blocking agents, since crossreactivity between neuromuscular blocking agents, both depolarizing and nondepolarizing, has been reported.