[e-drug] Nimesulide under focused pharmacovigilance in India (2)

["ibnsinaacademy" <ibnsinaacademy@gmail.com>]

E-DRUG: Nimesulide under focused pharmacovigilance in India (2)
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dear E-druggers,

The number of ADR reports is very minimal in India despite the National 
Pharmacovigilance Program. There could be many ADRs on Nimesulide-induced 
hepatitis or cardiovascular insufficiency, which are either not reported or have been missed by health care professionals.  

At the same time, it is surprising to note the alleged claim of the drug regulatory authorities of India that no ADR report had been received to them on the use of Nimesulide in the country so far to necessitate a review. There are many reports, letters and papers on this topic that could be found in Indian newspapers and journals. 

We sent the following papers / CD to the office of the Central Drug Surveillance Control Organization (CDSCO) for their information and necessary action:

1). KC Singal and SZ Rahman. Nimesulide Induced Hepatitis in a child of 5
years: A case Report (Short Communication). Newsletter of Society of
Pharmacovigilance, India, 2003, pp 6-7.

2). SZ Rahman & RA Khan. Is nimesulide safe in a cardiovascular-Compromised
patient? Indian J Pharmacol 2004; 36:252-253

3). RA Khan & SZ Rahman. Nimesulide Induced Coronary Artery Insufficiency -
A Case Report. J Pharmacovigilance Drug Safety 2004; 1: 11-13

4). RA. Khan & SZ Rahman. A Case Report on Nimesulide and Its Relation with
Angina. J Pharmacovigilance Drug Safety 2004; 1: 19-21

5). CD ROM, Appropriate Use of Antipyretics / Analgesics in Children, Health Informatics, New Delhi, 2004

With kind regards,

Syed Ziaur Rahman, MD
Aligarh, 
India
ibnsinaacademy@gmail.com