Antineoplastics/cotrimoxazole/omeprazole

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Reactions 1314 - 14 Aug 2010 S Antineoplastics/cotrimoxazole/ omeprazole Hemifacial paralysis: case report A 13-year-old boy developed hemifacial paralysis during treatment with omeprazole, cotrimoxazole [Bactrim; trimethoprim/sulfamethoxazole], IV cytarabine, IV cyclophosphamide and intrathecal methotrexate and cytarabine [duration of cotrimoxazole therapy to reaction onset and therapeutic indication not stated]. The boy was diagnosed with acute lymphoblastic leukaemia and received induction therapy with dexamethasone and asparaginase. He obtained complete remission and received reinduction treatment with oral dexamethasone, vincristine, doxorubicin and asparaginase. He had symptomatic complaints of his oesophagus and mouth and, as dexamethasone causes inflammation of the gastrointestinal tract, he started receiving omeprazole on 20 June [initial dosage not stated]. He had stomatitis and his next phase of treatment was delayed by 1 week. On 14 July, he started receiving IV cyclophosphamide 1000 mg/m 2 (day 1), tioguanine (days 1–14), IV cytarabine 75 mg/m 2 (days 3–6 and days 10–13), and triple intrathecal therapy of cytarabine 30mg, methotrexate 12mg and methylprednisolone (day 3). On 27 July, after completion of this protocol with the exception of one dose of tioguanine, he presented with sudden-onset of loss of sensitivity of the left side of his mouth and left-cheek swelling; at this time, he was receiving oral omeprazole 20mg once daily, oral cotrimoxazole 2 × 400mg daily, ondansetron and oral tioguanine. His symptoms rapidly progressed with development of left facial paresis, left-arm hemiparesis and dysarthria. Some hours later, his symptoms resolved and neurological examination was normal. He had a haemoglobin level of 73 g/L and a platelet count of 33 × 10 9 /L. Omeprazole was discontinued. He was observed in hospital over a 24-hour period with no recurrence of symptoms. Author comment: "[T]here is a ‘possible’ (code 3), according to the World Health Organisation criteria, causality of the hemifacial paralysis and the use of omeprazole. . . [T]he combination drug sulfamethoxazole/trimethoprim (Bactrim) received causality code ‘3’ (possible). . . [T]he patient also received intravenous cyclophosphamide, intravenous cytarabine, and an intrathecal therapy of methotrexate and cytarabine. All of these concomitant chemotherapy agents also received a causality code ‘3’ (possible)." Bauters TGM, et al. Hemifacial paralysis in a child treated for leukemia: Unusual side effect of omeprazole?. Journal of Oncology Pharmacy Practice 16: 129-132, No. 2, Jun 2010. Available from: URL: http:// dx.doi.org/10.1177/1078155209339443 - Belgium 803030590 1 Reactions 14 Aug 2010 No. 1314 0114-9954/10/1314-0001/$14.95 © 2010 Adis Data Information BV. All rights reserved

Transcript of Antineoplastics/cotrimoxazole/omeprazole

Page 1: Antineoplastics/cotrimoxazole/omeprazole

Reactions 1314 - 14 Aug 2010

SAntineoplastics/cotrimoxazole/omeprazole

Hemifacial paralysis: case reportA 13-year-old boy developed hemifacial paralysis during

treatment with omeprazole, cotrimoxazole [Bactrim;trimethoprim/sulfamethoxazole], IV cytarabine, IVcyclophosphamide and intrathecal methotrexate andcytarabine [duration of cotrimoxazole therapy to reactiononset and therapeutic indication not stated].

The boy was diagnosed with acute lymphoblasticleukaemia and received induction therapy withdexamethasone and asparaginase. He obtained completeremission and received reinduction treatment with oraldexamethasone, vincristine, doxorubicin and asparaginase.He had symptomatic complaints of his oesophagus andmouth and, as dexamethasone causes inflammation of thegastrointestinal tract, he started receiving omeprazole on20 June [initial dosage not stated]. He had stomatitis and hisnext phase of treatment was delayed by 1 week. On 14 July,he started receiving IV cyclophosphamide 1000 mg/m2

(day 1), tioguanine (days 1–14), IV cytarabine 75 mg/m2

(days 3–6 and days 10–13), and triple intrathecal therapy ofcytarabine 30mg, methotrexate 12mg andmethylprednisolone (day 3). On 27 July, after completionof this protocol with the exception of one dose oftioguanine, he presented with sudden-onset of loss ofsensitivity of the left side of his mouth and left-cheekswelling; at this time, he was receiving oral omeprazole20mg once daily, oral cotrimoxazole 2 × 400mg daily,ondansetron and oral tioguanine. His symptoms rapidlyprogressed with development of left facial paresis, left-armhemiparesis and dysarthria. Some hours later, hissymptoms resolved and neurological examination wasnormal. He had a haemoglobin level of 73 g/L and a plateletcount of 33 × 109/L. Omeprazole was discontinued. He wasobserved in hospital over a 24-hour period with norecurrence of symptoms.

Author comment: "[T]here is a ‘possible’ (code 3),according to the World Health Organisation criteria, causalityof the hemifacial paralysis and the use of omeprazole. . .[T]he combination drug sulfamethoxazole/trimethoprim(Bactrim) received causality code ‘3’ (possible). . . [T]hepatient also received intravenous cyclophosphamide,intravenous cytarabine, and an intrathecal therapy ofmethotrexate and cytarabine. All of these concomitantchemotherapy agents also received a causality code ‘3’(possible)."Bauters TGM, et al. Hemifacial paralysis in a child treated for leukemia: Unusualside effect of omeprazole?. Journal of Oncology Pharmacy Practice 16: 129-132,No. 2, Jun 2010. Available from: URL: http://dx.doi.org/10.1177/1078155209339443 - Belgium 803030590

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Reactions 14 Aug 2010 No. 13140114-9954/10/1314-0001/$14.95 © 2010 Adis Data Information BV. All rights reserved