Case Reports

121Urology Journal    Vol 4    No 2    Spring 2007

Results of Inadvertent Administration of Bacillus 
Calmette-Guerin for Treatment of Transitional Cell 
Carcinoma of Bladder 
Aliasghar Yarmohammadi, Hassan Ahmadinia, Mehran Abolbashari, Mahmood Molaei

Urol J. 2007;4:121-2. 
www.uj.unrc.ir

Keywords: bladder cancers, 
transitional cell carcinoma, bacillus 

Calmette-Guerin, intravesical 
instillation, intramuscular injection

Department of Urology, Ghaem 
Hospital, Mashhad University of 

Medical Sciences, Mashhad, Iran

Corresponding Author:
Aliasghar Yarmohamadi, MD

No 13, 6th Mina St, Ibne Sina St, 
Bahar Ave, Mashhad, Iran

Tel: +98 511 761 1868
Fax: +98 511 841 7404

E-mail: yaghoti2005@yahoo.com

Received October 2006
Accepted March 2007

INTRODUCTION
Intravesical instillation of  bacillus 
Calmette-Guerin (BCG) is a known 
treatment method in superficial 
bladder cancers after transurethral 
resection of  the bladder tumor 
(TURBT).(1) Moreover, its 
polysaccharide nucleotide is used in 
the treatment of  asthma.(2) However, 
the most familiar usage of  the BCG 
to the public is vaccination against 
tuberculosis (TB) as a subcutaneous 
injection or oral administration.(3) 
Physicians should explain method of  
its use to the patients in order to avoid 
wrong injection and its side effects. In 
this study, we present a patient with 
transitional cell carcinoma (TCC) of  
the bladder in whom 4 vials of  BCG 
were wrongly injected intramuscularly. 

CASE REPORT
A 60-year-old man with a history of  
TURBT was recommended to have 
1 course (6 doses) of  intravesical 
BCG instillation. However, the 
patient traveled to another city and 
the injection was done erroneously; 
2 vials of  BCG (120 mg) were 
intramuscularly injected 2 weeks 
after TURBT with an interval of  12 
hours. After the second injection, the 
patient experienced severe headache, 
sweating, and fever. The following day, 
2 other vials of  BCG were injected 

in the gluteal muscles and headache 
and sweating developed again. Three 
days after the intramuscular injections, 
the patient experienced pain and 
induration in the site of  injections and 
severe pain in the hypogastric area. 
He referred to his own physician and 
inravesical instillation of  BCG was 
administered. The first and second 
intravesical BCG vials, diluted in 50 
milliliters of  normal saline were used 
intravesically about 3 and 4 weeks 
after the TURBT. 

He presented to our center almost 
1.5 months after the TURBT. On 
physical examination, pain, erythema, 
tenderness, and induration were 
detected bilaterally in the gluteal 
muscles. Ultrasonographic evaluations 
revealed no abscess. Urinalysis showed 
abundant red blood cells, 15 to 16 
white blood cells per high-power 
field, and fungal mycelium. Mantoux 
screening test was negative after 48 
hours. Morning urine samples and 
gastric lavage in 3 consecutive days 
were negative for mycobacterium 
tuberculosis. Chest radiography 
was performed and no active or 
old lesion of  TB was detected. On 
the intravenous urography, delay in 
the secretion of  the right kidney, 
dilatation in the pyelocaliceal system 
and the right ureter, and irregularities 
in the ureteropelvic junction were 



Bacillus Calmette-Guerin and Transitional Cell Carcinoma of Bladder—Yarmohammadi et al 

122 Urology Journal    Vol 4    No 2    Spring 2007

detected. According to the consultation with 
the experts in TB, oral isoniazid, 300 mg/d, and 
rifampin, 600 mg/d, were started for the patient. 
The classic treatment of  bladder TCC was continued 
after making sure that no side effect of  BCG 
administration remained.

DISCUSSION
For achieving useful results by BCG therapy for 
the superficial bladder tumors, its appropriate 
use is crucial. Otherwise, unwanted side effects 
may develop. This necessitates giving complete 
information to the patients. Bacillus Calmette-Guerin 
is generally used subcutaneously, and sometimes, 
its oral or intranasal administration is used for 
vaccination. Its intravesical instillation is applied for 
the superficial bladder tumors.(1-3) 

Side effects of  subcutaneous injection of  BCG are 
usually restricted to the injection area, and systemic 
involvement is rarely seen.(4,5) The adverse effects 
include lymphadenopathy, local scar, and systemic 
TB. To our knowledge, intramuscular injection of  
BCG has only been reported in 2 patients.(6,7)  In one 
of  those patients, abscess was formed in the muscle 
which was resolved by conservative treatment.(7) The 
amount of  injected solution was very lower in these 
cases in comparison with ours. Due to the scarcity 
of  intramuscular injection of  BCG, the treatment 
and follow-up strategies of  the affected patients is 
not clear yet. In our patient, in spite of  2 injections 
of  BCG in the gluteal muscles and then, instillation 
into the bladder, no paraclinical findings indicative of  
the disease were found. However, empirical treatment 
with oral isoniazid and rifampin was initiated and 
continued for 3 months according to the consultation 
with the specialists in infectious diseases. During this 
period, no sign of  TB or gluteal abscess was detected. 
The literature lacks evidence to support our treatment 
of  TB for the patient. However, due to the large 
amount of  injection and the history of  fever, pain, 

tenderness, swelling, and redness in the gluteal region 
during the first days after injections, we preferred 
to perform prophylactic treatment with isoniazid 
and rifampin. After 8 months, no complication was 
detected. However, some gastrointestinal problems, 
delayed intravesical treatment with BCG, loss of  time 
and money of  the patient, and negative psychological 
effects on the patient were the consequences of  the 
inadvertent intramuscular injections of  BCG. Such 
problems are the things that should be prevented by 
educating the patients and the health care personnel. 
On the other hand, there is an interesting question to 
be brought forward: does the intramuscular injection 
of  BCG affect—either negatively or positively—the 
clinical course of  bladder cancer?

CONFLICT OF INTEREST
None declared.

REFERENCES
1. Prapotnich D. [BCG therapy of superficial tumors of 

the bladder]. Bull Cancer. 1998;85:135-9. French.

2. Li J, Luo DF, Li SY, Sun BQ, Zhong NS. Efficacy of 
intramuscular BCG polysaccharide nucleotide on 
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controlled study. Chin Med J (Engl). 2005;118:1595-
603.

3. Lamm DL, Sarodosy MS, DeHaven JI. Percutaneous, 
oral, or intravesical BCG administration: what is the 
optimal route? Prog Clin Biol Res. 1989;310:301-10. 

4. Bolger T, O>Connell M, Menon A, Butler K. 
Complications associated with the bacille Calmette-
Guerin vaccination in Ireland. Arch Dis Child. 
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5. Bellet JS, Prose NS. Skin complications of Bacillus 
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6. [Intramuscular administration of BBC vaccine--a 
warning]. Lakartidningen. 1977;74:445. Swedish.

7. Pasteur MC, Hall DR. The effects of inadvertent 
intramuscular injection of BCG vaccine. Scand J Infect 
Dis. 2001;33:473-4.