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Indian Pediatrics 1999;36: 1067-1069

Diclofenac Induced Fatal Anaphylactic Reaction

Diclofenac sodium is a nonsteroidal anti-inflammatory drug (NSAID) which belongs to the phenylacetic acid group. It is used in inflammatory conditions of various etiologies, degenerative joint disease and many other  painful conditions. Although its mechanism of action is the inhibition of prostaglandin synthesis it also decreases lipooxygenase products by enhancing the uptake of arachidonic acid into triglycerides. The common unwanted side effects are gastritis, peptic ulceration and depression of renal function. Anaphylaxis to diclofenac is an idio-syncratic reaction and is a very rare event(1).

A review of the medical literature revealed only a few cases in adults and none so far in children(2,3). We hereby report a case of anaphylactic shock induced by diclofenac in a child.

A nine years old girl was treated with ibuprofen for toxic synovitis. As her pain did not respond within two days she was prescribed diclofenac sodium in the dose of 2 mg/kg/d. She developed pruritus all over the body after the first dose. The child was rushed to the hospital three hours after the second dose when she was noted to have an erythematous urticarial, pruritic rash all over the body, swelling of hands and feet, cold clammy extremities and tightness of chest. On examination she was conscious but irritable, had absent peripheral pulses, prolonged capillary filling time, tachycardia, tachypnea and unrecordable blood pressure. In view of the temporal relation to intake of diclofenac, she was diagnosed as a case of anaphylactic shock. She was managed with oxygen, adrenaline, steroids, crystalloid and colloid boluses and inotrope infusions. Inspite of the above measures she did not recover from shock and was declared dead 12 hours after admission. History taken from the family revealed that the patient was on no other medication and there was no history of atopy.

The reported case of anaphylactic reaction was due to oral administration of diclofenac. This view is supported by the sequential association between the administration of diclofenac and the patient's symptoms and abrupt onset of illness with lack of previous symptoms.

Severe reactions to commonly used drugs are well-documented in medical literature and remain a potential threat in daily practice. Patients reacting to NSAIDs have `anaphylac-toid reaction' which is believed not to be immunologically mediated but due to direct  suppression of prostaglandin synthesis. These are acute life threatening illnesses manifested by hypotension, bronchospasm, diffuse erythema, laryngeal edema, cardiac dysrrhythmia, urticaria and pruritus either in combination or alone. There is evidence that cross reactive anaphylactic reaction to NSAIDs can occur in some aspirin sensitive patients(2). Thus the role of ibuprofen which was being taken by this child prior to diclofenac in the induction of hypersensitivity is unclear.

Safety data from clinical trials in United States have shown that diclofenac has lower rates of adverse reactions than patients receiving any of the comparative NSAIDs in adults(4) but this drug is generally not recommended in children(5), especially those below 18 months(6). This communication is to bring awareness amongst all those managing acute pain in childhood that diclofenac sodium may not be a safe drug in children and fatal anaphylactic reactions may occur.

Munni Ray,
Sudeshna Mitra,
Veena Parmar,
Department of Pediatrics,
Government Medical College Hospital,
Chandigarh 160 047, India
.

References

1. Obrien WM. Adverse reactions to nonsteroidal anti-inflammatory drugs. Diclofenac compared with other non-steroidal anti-inflammatory drugs. Am J Med 1986; 80: 70-80.

2. Alkhawajah AM, Eifawal M, Mahmous SF. Fatal anaphylactic reaction to diclofenac. Forensic Sci Int 1993; 60: 107-110.

3. Milman U, Hermoni D. Anaphylactic reaction to oral diclofenac sodium sustained release tablet. Isr J Med Sci 1994; 30: 909-910.

4. Catalano MA. Worldwide safety experience with diclofenac. Am J Med 1986; 80: 81-86.

5. Insel PA. Analgesic antipyretic and anti  inflammatory agents and drugs employed in the treatment of gout. In: Goodman and Gilman's The Pharmacological Basis of Therapeutics, 9th edn. Eds. Harman JG, Limbrid LE. New York, Mc Graw Hill Companies, 1995; pp 617-658.

6. Todd PA, Sorkin EM. Diclofenac sodium. A reappraisal of pharmacodynamic and pharmaco-kinetic properties and therapeutic efficacy. Drugs 1988; 35: 244-249.

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