This is the retyped text of a letter from Apothecon. Contact the company for a copy of any referenced enclosures.
April 3, 1997
- Subject:
-
CARDIAC ARREST IN CHILDREN AND ADOLESCENT
PATIENTS RECEIVING SUCCINYLCHOLINE
- SUCCINYLCHOLINE-INDUCED HYPERKALEMIA
Dear Anesthesia Practitioner:
Bristol-Myers Squibb Company wants to call your attention to
two life-threatening events that may occur with the use of
succinylcholine, and to alert you to important changes being made
to the product label for SUCOSTRIN brand succinylcholine.
SUMMARY OF NEW WARNINGS AND CONTRAINDICATIONS
- Except when used for emergency tracheal intubation or in instances
where immediate securing of the airway is necessary,
- Succinylcholine is contraindicated in patients after the acute phase of
injury following major burns, multiple trauma, extensive denervation of
skeletal muscle, or upper motor neuron injury because succinylcholine
administration to such individuals may result in severe hyperkalemia
which may result in cardiac arrest. The risk of hyperkalemia in these
patients increases over time and usually peaks at 7 to 10 days after
the injury. The risk is dependent on the extent and location of the injury.
The precise time of onset and the duration of the risk period are not
known.
CARDIAC ARREST IN CHILDREN AND ADOLESCENT PATIENTS RECEIVING
SUCCINYLCHOLINE
There have been several reports of cardiac arrest following administration
of succinylcholine to apparently healthy children and adolescent patients
who were subsequently found to have undiagnosed myopathies. In most cases,
patients experienced acute rhabdomyolysis with hyperkalemia and cardiac
arrest. 1-4
Because children and adolescent patients are more likely than
adults to have such undiagnosed myopathies, a non-depolarizing
neuromuscular blocking drug should be used for routine elective
surgery in these patients. Succinylcholine remains the drug of
choice when emergency intubation or immediate securing of the airway is
indicated.
SUCCINYLCHOLINE-INDUCED HYPERKALEMIA
Clinical reports have demonstrated an association between hyperkalemia and
the administration of succinylcholine to certain populations with catabolic
states. First described in burn patients, the phenomenon is now recognized
in patients with severe abdominal infections, tetanus, massive trauma and
neuromuscular disease. Over a dozen case reports and letters have been
published reporting hyperkalemia after administration of succinylcholine
to patients with burns, massive trauma, stroke and spinal cord injury.
5-15 A common denominator appears to be either massive tissue
destruction or CNS injury with muscle wasting.
Attempts have been made to identify the period of risk. 5,16,17
Skeletal muscle denervation hypersensitivity usually develops over
several weeks but can occur as early as one to two days after injury. In
an experimental canine model, hyperkalemia following succinylcholine
administration developed seven days after denervation. 11 In
humans, the hyperkalemic response to succinylcholine can persist for over
six months after neural injury. 6,10 Insufficient data exist to
define the period of risk for development of succinylcholine-induced
hyperkalemia after major burns or neuromuscular injuries.
The enclosed package insert for SUCOSTRIN brand succinylcholine has been
revised to incorporate these and a number of other important changes.
Please carefully read the entire enclosed package insert. If you have
questions about this matter, please contact our Drug Information
Department (800-321-1335).
Sincerely,
Walter G. Jump, Pharm.D.
Senior Director
Medical & Regulatory Operations
Apothecon
PO Box 4500
Princeton
New Jersey 08543-4500
Telephone: (609) 897-2000
A Bristol-Myers Squibb Company
References
- Delphin E, et al. Use of succinylcholine during elective pediatric
anesthesia should be re-evaluated. Anesth Analg. 1987; 66:1190-1192.
- Gurgey A. Malignant hyperthermia is a patinet with sickle cell anemia.
Turk J Pediatr 1989; 31:245-248.
- Mehler H, et al. Cardiac arrest during induction of anesthesia with
halothane and succinylcholine in an infant. Severe hyperkalemia and
rhabdomyolysis due to a suspected myopathy and/or malignant hyperthermia.
Anaesthetist. 1991; 40:497-501.
- Rosenberg H, Gronert GA. Intractable cardiac arrest in children
given succinylcholine. Anesthesiol. 1992; 77:1054 (letter).
- Cooperman LH. Succinylcholine-induced hyperkalemia induced by
succinylcholine. JAMA. 1970;213:1867-1871.
- Gronert GA, Theye RA. Pathophysiology of hyperkalemia induced by
succinylcholine. Anesthesiology. 1975; 43:89-99.
- John DA, et al. Onset of succinylcholine-induced hyperkalemia
following denervation. Anesthesiology. 1976; 45:294-299.
- Tobey RE. Paraplegia, succinylcholine and cardiac arrest.
Anesthesiology. 1979;32:359-364.
- Tobey RE, et al. The serum potassium response to muscle relaxants
in neural injury. Anesthesiology. 1972; 37:332-337.
- Tolmie JD, et al. Succinylcholine danger in the burned patient.
Anesthesiology. 1967; 28:467-470.
- Mazze RI, et al. Hyperkalemia and cardiovascular collapse following
administration of succinylcholine in the traumatized patient.
Anesthesiology. 1969; 31:540-547.
- Nash CL, et al. Succinylcholine, paraplegia, and intraoperative
cardiac arrest. A case report. J Bone Joint Surg.
1981;63A:1010-1012.
- Walker DE, et al. Succinylcholine-induced ventricular
fibrillation in the paralyzed urology patient. J Urol. 1975;
113:11-13.
- Walters FJ, Nott MR. The hazards of anesthesia in the injured patient.
Br J Anaesth. 1977;49:707-720.
- Williams, CH, et al. Effect of intravenously administered
succinylcholine on cardiac rate and rhythm and arterial blood
pressure in anesthetized men. Anesthesiology. 1961; 22:947.
- Carter JG, et al. Effect of spinal cord transection on neuromuscular
function in the rat. Anesthesiology. 1981; 55:542-546.
- Stone WA, et al. Succinylcholine-induced hyperkalemia in dogs
with transected siatic nerves or spinal cords. Anesthesiology. 1970;
32:515-519.
Return to Summary