E-drug: New drugs and adverse drug reactions
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Thought this letter from The Lancet 24 April would be of interest to E-druggers.
Volume 353, Number 9162 24 April 1999
New drugs, new adverse drug reactions, and bibliographic databases
Sir--P A McCormick and colleagues (Jan 2, p 40) 1 describe a woman who
developed fulminant hepatic failure (FHF) after treatment with the COX2
selective inhibitor, nimesulide. They state that to their knowledge, FHF due
to nimesulide had not been reported previously.
Last year, one of us (FE) approached his colleagues in Barcelona because he
was aware of a series of five patients who developed hepatic injury associated
with nimesulide, two of whom died as a result of FHF. He needed information on
regulatory decisions on this matter in Europe, because the report was pending
evaluation by the Uruguayan drug-regulatory authority.
This case illustrates how the dynamics of knowledge on new adverse-drug
reactions are changing in the global economy. When a new drug is licensed, its
adverse effects are incompletely known, because only a limited number of
healthy
volunteers and highly selected patients have taken it. Thus, efficient
postmarketing drug surveillance is needed, but unfortunately such
surveillance does not exist or is inadequate in less developed countries. On
the other hand, an increasing number of drugs are marketed and widely used
first in non-English-speaking, less developed countries (eg, South America),
where submissions for drug registration may be less rigorous or drug
registration is simply non-existent. Clinicians from less developed
non-English speaking countries in the South rarely publish in
English-language widely circulated medical journals. This issue is
particularly relevant with new drugs which, as is the case of non-steroidal
anti-inflammatory drugs, can be sold in inadequately regulated countries,
where the influence of pharmaceutical firms on drug prescribing is greater
than in more developed countries. As with randomised clinical trials,3
case-reports published in non-English languages could be perceived as a
second-best evidence of causality.
Implementation of the World Trade Organization principles of free
circulation of
goods should imply that the procedures, criteria, and drug regulations of more
developed countries are implemented just as rigorously in less developed
countries. Meanwhile, editors of the leading medical journals should be
attentive to knowledge of the safety issues from those countries where new
drugs are marketed first.
A Figueras, F Est�vez, *J-R Laporte
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*Institut Catal� de Farmacologia, Departament de Farmacologia, Universitat
Aut�noma de Barcelona, E-08035 Barcelona, Spain; and Departament de
Farmacologi� Cl�nica, COCEMI, Montevideo, Uruguay
1 McCormick PA, Kennedy F, Curry M, Traynor O. COX 2 inhibitor and fulminant
hepatic failure. Lancet 1999; 353: 40-41.
2 Grignola JC, Arias L, Rond�n M, Sol� L, Bagnulo H. Hepatotoxicidad asociada a
nimesulida. Revisi�n de 5 casos. Arch Med Int 1998; 20: 13-18.
3 Moher D, Fortin P, Jadad AR, et al. Completeness of reporting of trials
published in languages other then English: implications for conduct and
reporting of systematic reviews. Lancet 1996; 347: 363-66.
http://www.thelancet.com/newlancet/sub/issues/vol353no9162/menu_NOD12.html
(need access code)
Kirsten Myhr, MScPharm, MPH
myhr@online.no
E-drug moderator
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