[e-farmacos] Consulta sobre reaccion adversa (cont.)

["Oliveira, Vilberto" <voliveira@prefeitura.sp.gov.br>]

E-farmacos: Consulta sobre reaccion adversa (cont.)
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Ola Marcela,

No link a seguir tem uma lista de medicamentos responsaveis por
TBCitopenia, nao consta a risperidona e a teico:
http://www.farmacovigilanza.org/patologie_iatrogene/142.asp 

mas segundo monografia do Drugdex(r)os tres farmacos podem produzir
trombocitopenia.

Veja as Informaçoes estao baixo.

Vilberto.


Vilberto C. Oliveira
CENTRO DE INFORMAÇOES SOBRE MEDICAMENTOS-SMS
COGest-Area Tematica De Assistencia Farmaceutica
Fone: 3051- 8422 cim@prefeitura.sp.gov.br
Av. Brigadeiro Luiz Antonio, 4805, 1o andar, sala 101,  CEP  01401-002
Sao Paulo
(Brasil)


Teicoplamina

A. HEMATOLOGIC EFFECTS 
1. SUMMARY: Neutropenia, reversible eosinophilia, spontaneous platelet
aggregation, thrombocytopenia and leucopenia with neutropenia have been
described with teicoplanin.  
A. HEMATOLOGIC EFFECTS 
1. SUMMARY: Neutropenia, reversible eosinophilia, spontaneous platelet
aggregation, thrombocytopenia and leucopenia with neutropenia have been
described with teicoplanin.  
B. EOSINOPHILIA 
1. Reversible EOSINOPHILIA has been noted in 5 patients who received
parenteral teicoplanin in clinical trials (Bibler et al, 1987;
Glupczynski et al, 1986). Eosinophilia was defined as a total eosinophil
count of greater than 450/mm(3) (Bibler et al, 1987). 
C. LEUKOPENIA/NEUTROPENIA 
1. NEUTROPENIA (pre-therapy leukocyte count of 7800 cells/cubic
millimeter/polymorphonuclear leukocytes at 64.8%; nadir leukocyte count
of 1800 cells/cubic millimeter/ polymorphonuclear leukocytes at 40.5%)
and rash
developed in a 10-year-old boy approximately 14 days after beginning a
course of intravenous teicoplanin 300 milligrams (mg) every 24 hours for
treatment of osteomyelitis. This was accompanied by approximately 4 days
of
fever. Rash and fever resolved within 3 days of discontinuing
teicoplanin, yet recurred after rechallenge with a single dose of
intravenous teicoplanin 300 mg (Wee & Oh, 2001). Two other case reports
of neutropenia have been reported with intravenous teicoplanin therapy
(Pauluzzi et al, 1987; Calain et al, 1987). The neutropenia was
transient and reversible. One patient had a white blood cell count of
7800/mm(3) with 85% neutrophils prior to therapy. This decreased to
2300/mm(3) with 31% neutrophils after 7 days of intravenous therapy with
an initial dose of 400 mg followed by 200 mg every 24 hours. The
neutrophil count and white blood cell count improved following
discontinuation of the drug (Calain et al, 1987).  
2. Leukopenia with neutropenia was described in a 73-year-old male with
Streptococcus faecalis endocarditis after receiving teicoplanin 9 mg/kg
daily (600 mg, as a single dose) for 21 days. At that time, the white
blood cell count had decreased to 2000/mm(3); neutrophils 46%,
lymphocytes 48%, monocytes 5% and eosinophils 1%. Withdrawal of the drug
resulted in normalization of white blood cell and neutrophil counts,
however leukopenia with neutropenia again occurred upon rechallenge. The
white blood cell count again increased gradually after drug withdrawal.
Based upon a review of the literature, the authors indicate that the
incidence of teicoplanin-induced leukopenia is low (0.33%) and the
leukopenia is reversible. Monitoring of
the white blood cell count is suggested during teicoplanin therapy (Del
Favero et al, 1989). 
D. PLATELET EFFECTS 
1. Serum teicoplanin concentrations of 100 to 1500 mcg/mL had no effect
on platelet function; however, higher concentrations (5000 to 10,000
mcg/mL) induced spontaneous PLATELET AGGREGATION (Agnelli et al, 1987).
Additionally, the higher teicoplanin concentrations inhibited platelet
aggregation that was induced by adenosine phosphate (ADP), collagen, and
ristocetin. Similar results have been reported elsewhere (Cazzola et al,
1993). These in vitro clinical trials demonstrate that normal
therapeutic concentrations of teicoplanin will not affect platelet
function or blood coagulation despite the structural similarity to
ristocetin, which is an antibiotic that is known to induce platelet
agglutination.  
2. Severe reversible thrombocytopenia was reported after 10 days of
teicoplanin therapy in a 24-year-old woman with a coagulase-negative
staphylococcus infection (Veldman et al, 1996). A teicoplanin loading
dose of 400 mg was followed by 200 mg once a day. On the sixth day of
therapy, the teicoplanin serum concentration 5 hours after
administration was 32.6 mg/L. The thrombocytopenia reversed 8 days after
the teicoplanin was discontinued. Clinicians should carefully monitor
platelets as a previous report of teicoplanin-induced thrombocytopenia
with a positive rechallenge has been reported (Terol et al, 1993). 


Vancomicina
BLOOD 
A. HEMATOLOGIC EFFECTS 
1. Neutropenia, thrombocytopenia, and agranulocytosis have occurred with
vancomycin therapy. 
B. AGRANULOCYTOSIS 
1. SUMMARY: 
a. Agranulocytosis has rarely been reported following vancomycin therapy
(Prod Info Vancocin(R), 2000). In a 45-year old white woman,
agranulocytosis developed 20 days after initiating vancomycin for
decubitus ulcers. The white blood cell count declined to 2.7 x
10(3)/cubic millimeter with only 3% neutrophils and no eosinophils or
basophils. Vancomycin was discontinued and the patient had complete
recovery within one week. A concomitant medication was
ticarcillin/clavulanate, which could have also been causative. A
possible immunologic mechanism has been postulated to cause the
agranulocytosis (Mandl et al, 1997). 
C. EOSINOPHILIA 
1. SUMMARY: 
a. Eosinophilia has infrequently been reported with administration of
vancomycin (Prod Info Vancocin(R),  2000). 
D. NEUTROPENIA 
1. SUMMARY: 
a. Reversible neutropenia has been reported in several dozen patients
receiving vancomycin. The neutropenia usually starts 1 week or more
after the onset of therapy or after a total dosage of more than 25
grams. 
Neutropenia is promptly reversed after discontinuation of therapy (Prod
Info Vancocin(R), 2000; Lai et al, 1996; Mackett & Guay, 1985; Borland
and Farrar 1979; Mandl et al, 1997). 
2. LITERATURE REPORTS: 
a. Vancomycin-induced neutropenia was reversible by administration of
granulocyte colony-stimulating factor (g-CSF) in two patients receiving
long-term vancomycin therapy as outpatients (Lai et al, 1996).
Interruption
of the vancomycin therapy was not necessary. A 37-year-old received a
cumulative dose of 83 grams of vancomycin when his absolute neutrophil
count (ANC) was 483/cubic millimeter (mm3). G-CSF 600 micrograms (mcg)
twice a week was administered initially and then reduced to 300 mcg
twice a week until vancomycin therapy was discontinued. G-CSF 300 mcg
was given to another patient with low ANC after receiving a cumulative
dose of 30 grams of vancomycin. In both patients the G-CSF was titrated
to maintain an ANC of greater than 1000/cubic millimeter and vancomycin
therapy was continued.  
b. Vancomycin 250 milligrams administered intravenously every 12 hours
for 17 days was associated with the occurrence of neutropenia in a
67-year- old woman with cellulitis and sepsis (Staphylococcus aureus).
Withdrawal of vancomycin resulted in increases in neutrophil count over
the next five days (Mackett & Guay, 1985). It is suggested that long-
term vancomycin therapy be accompanied by periodic monitoring of
leukocyte counts.  
c. A case of reversible neutropenia was attributed to vancomycin. On the
35th day of treatment the neutrophil count was 500/cubic millimeter in
this 10-year-old female. Other drugs were administered concurrently;
however, the neutrophil count began to rise the day following
discontinuance of vancomycin (Borland and Farrar 1979).  
E. THROMBOCYTOPENIA 
1. SUMMARY: 
a. Thrombocytopenia is a rare effect of vancomycin therapy (Prod Info
Vancocin(R), 2000). 
2. LITERATURE REPORTS:  
a. Thrombocytopenia, with increased megakaryocytes in the bone marrow,
occurred in a 58-year-old man receiving therapeutic doses of vancomycin
of 1.75 grams intravenous every 24 hours for a methicillin-resistant
Staphylococcus aureus infection. The reaction was confirmed upon
re-exposure to the drug. Direct toxic effects, innocent bystander immune
response, drug absorption or hapten formation are possible mechanisms.
Peripheral blood smear revealed microcytic anemia, a decreased number of
platelets, and many enlarged platelets, but no platelet clumping. Four
other reports of vancomycin thrombocytopenia are reviewed in this case
report, which also states 119 spontaneous reports of thrombocytopenia
have been filed with Eli Lilly and Company (Howard et al, 1997; Walker &
Heaton, 1985).  
b. Severe thrombocytopenia occurred in a 48-year-old female who
developed peritonitis secondary to peritoneal dialysis (Walker & Heaton,
1985). Vancomycin 500 milligrams (mg) administered intravenously
followed by 120 mg 
daily intraperitoneally in four divided doses was given. Six days later
the patient developed spontaneous bruising, and bleeding of the tongue
and gums; thrombocytopenia was present. Therapy was discontinued and the
platelet count increased over the next few weeks. An autoimmune or
immune-complex etiology was suggested as the cause of the
thrombocytopenia. 


Risperidona
BLOOD 
A. HEMATOLOGIC EFFECTS 
1. Agranulocytosis, leukopenia, neutropenia, anemia, hypochromic anemia,
purpura, epistaxis, thrombocytopenia, leukocytosis, lymphadenopathy,
hemorrhage, thrombophlebitis, superficial phlebitis, Pelger-Huet anomaly
and
normocytic anemia have been reported with risperidone therapy.  
B. AGRANULOCYTOSIS 
1. SUMMARY: 
a. CASE REPORT - A 40-year-old woman developed agranulocytosis after 2
weeks of risperidone treatment. She had previously experienced
agranulocytosis with other antipsychotic therapies: chlorpromazine with
carbamazepine (white blood cell (WBC) count 2500/cubic millimeter
(mm(3)) and neutrophil rate=30%), haloperidol (WBC=2200/mm(3),
neutrophil rate=52%), and zuclopenthixol (WBC=2700/mm(3), neutrophil
rate 29%). With risperidone 4 milligrams/day, her WBC was 2400/mm(3) and
her neutrophil count was 32% (Finkel et al, 1998). 
C. HEMATOLOGIC FINDINGS 
1. SUMMARY: 
a. During pre-marketing (n=2607) evaluation of risperidone, ANEMIA,
HYPOCHROMIC ANEMIA, PURPURA, and EPISTAXIS were reported in 1 in 100 to
1 in 1000 patients. In the same population THROMBOCYTOPENIA,
LEUKOCYTOSIS,
LYMPHADENOPATHY, HEMORRHAGE, THROMBOPHLEBITIS, SUPERFICIAL PHLEBITIS,
PELGER-HUET ANOMALY (disorder of neutrophil differentiation), and
NORMOCYTIC ANEMIA have been reported in fewer than 1 in 1000 patients
(Prod Info Risperdal(R), 1997). 
D. LEUKOPENIA 
1. SUMMARY: 
a. Leukopenia that includes neutropenia has been reported with
risperidone therapy (Dernovsek & Tavcar, 1997; Meylan et al,1995; Prod
Info Risperdal(R), 1997). 
2. LITERATURE REPORTS: 
a. A 63-year-old man developed leukopenia and NEUTROPENIA 1 week after
beginning risperidone 2 milligrams(mg) twice daily for schizophrenia.
The reaction was confirmed upon rechallenge. He had experienced a
similar
reaction with clozapine (Dernovsek & Tavcar, 1997). 
b. A case of leukopenia, possibly related to risperidone, was reported
following 7 days of therapy (2 to 6 milligrams/day) for schizophrenia.
The white count decreased from 5100/ cubic millimeter (mm(3)) to
3500/mm(3) over 7 days, and the neutrophil count decreased from
3430/mm(3) to 1820/mm(3). On day 9, the neutrophil count had further
decreased to 980/mm(3). The patient also had influenza during this same
time period which may have confounded the circumstances (Meylan et al,
1995). 


[NOTA: Mensaje sin acentos ni caracteres especiales.]
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