[e-farmacos] Efectos sistemicos de timolol oftalmico (cont.)

["Montane, Eva" <eme@icf.uab.es>]

E-farmacos: Efectos sistemicos de timolol oftalmico (cont.)
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Estimado Manuel,

Adjunto el abstract de un estudio realizado en la Fundacion Institut
Catala de Farmacologia (Montane E, Pedros C, Ferro J, Ibanhez L,
Figueras A. Systemic adverse effects of topical drugs gathered by a
spontaneous 
reporting system. _Meth Find Exp Clin_ _Pharmacol_, _20 (suppl A)_, 96,
1998) en el que se analizaron las reacciones sistemicas producidas por
farmacos de administracion topica. 

Se seleccionaron las notificaciones espontaneas de Targeta Amarilla
(1983-1998) que describian reacciones 
sistemicas secundarias a farmacos de administracion topica. Se
identificaron 10 notificaciones cuyo farmaco sospechoso fue timolol. En
4 de ellas se decribieron alteraciones del ritmo cardiaco y en 5
notificaciones cuadros de broncoespasmo en pacientes con antecedentes de
enfermedad pulmonar obstructiva cronica.

Atentamente,

Ena Montane
Fundacion ICF
Barcelona
eme@icf.uab.es

Systemic adverse effects of topical drugs gathered by a spontaneous
reporting system.

Montane E, Pedros C, Ferro J, Ibanhez L, Figueras A. 
Institut Catala de Farmacologia. Vall d?Hebron Hospitals. P. Vall
d?Hebron 119-129. 08035 - Barcelona (Spain).

The application of topical drugs (TDs) to treat several diseases can
produce significant systemic adverse drug reactions (ADRs) in some
patients. We describe the ADRs attributed to TDs spontaneously reported
to the Catalan Centre of the Spanish Pharmacovigilance System between
1983 and January 1998. Reports attributed to drugs applied by
ophthalmic, cutaneous, otic, inhaled or intranasal routes had been
initially selected (601); of those, ADRs attributed to drugs applied by
topical routes to obtain systemic effects (i.e. nitroglycerin, 
calcitonin, sexual hormones), and ADRs attributed to a TD plus one or
more non-TD were excluded. The remaining 133 reports described 206 ADRs
attributed to 141 drugs administered mainly by cutaneous (n=57; 40%), or
inhaled (n=37; 26%) routes. The therapeutic groups most frequently
implicated were R (respiratory tract, n=48; 34%) and S (vision and
hearing disorders, n=31; 22%). Individual TDs most frequently reported
were ketoprofen (n=11; 7.8%), timolol (n=10; 7.1%), and salbutamol and
salmeterol (n=8; 5.6% each one). Seven reports described
life-threatening ADRs (3 cardiovascular ADRs in patients treated with
b_2 -agonists), and 47 described serious episodes. The most frequently
reported ADRs were those affecting the skin (n=60; 29%), CNS (n=30;
14.6%) and the cardiovascular system (n=29; 14.1%). The table shows the
most frequently ADR-TD reported association.


-----------------------------------------------------------------
drug - route - ADRs (n reports) - notes
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NSAIDs - cutaneous - UGIB (6) - 3 patients with previous history of
peptic ulcer

-  - bronchospasm (3) - 1 patient with previous history of bronchial
asthma

b-blockers - conjunctival - rhythm disorder (4) -

-  - bronchospasm (5) - 5 patients with previous history of COPD

b_2 -agonists - inhaled - tachyarrhythmia (5) -

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NSAID :non-steroidal antiinflamatory drugs; UGIB: upper gastrointestinal
bleeding; COPD: chronic obstructive pulmonary disease

Eighteen reports refer to ADRs occurred in children (under 15 years);
TDs more frequently implicated were inhalers.

Drugs with intended local effects applied by topical route can be
absorbed to some extend and can produce potentially severe systemic
ADRs. This hazard is specially important to be born in mind when
treating patients with several risk factors which, on the other hand,
are more susceptible to receive those drugs.


[NOTA: Mensaje sin acentos ni caracteres especiales.]

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