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Helsinn Healthcare SA - Nimesulide is a safe drug

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With reference to the Irish Medicine Board (IMB)
decision, mainly based on 6 cases of hepatic damage, to suspend the
marketing and sale of nimesulide and following the request to the
European Committee for Medicinal Products for Human Use (CHMP) to
revise the benefit/risk profile of the drug, Helsinn Healthcare deems
opportune to specify that nimesulide is a drug with a positive safety
profile as demonstrated by the 500 million patients to whom it has
been administered in the last 22 years.
The alleged correlation between the use of nimesulide and the 6
cases of hepatic damage occurred between 1999 and 2006, as reported
by the National Liver Transplant Unit at St. Vincent's University
Hospital (Ireland), is still under evaluation.
Liver damage is a rare adverse effect that is already known with
regards to the entire non-steroidal anti-inflammatory drugs
therapeutic class (NSAIDs), as indicated in the Summary of Product
Characteristics (SPC).
In a recent and independent study (G. Traversa, C. Bianchi, R, Da
Cas, I. Abraha, F. Menniti-Ippolito and M. Venegoni) performed on
behalf of the Italian National Health Service Scientific Body
(Istituto Superiore di Sanità -ISS) and published by the British
Medical Journal, the risk of liver damage correlated to NSAIDs
administration was classified as extremely rare, and was specifically
observed that there were no differences between the use of nimesulide
and other drugs of the same therapeutic class.
In 2003, nimesulide has already been under revision by the EMEA
which confirmed the positive benefit/risk ratio in correct usage
conditions and in accordance to the prescribing information and
indications: it is here underlined that the drug can be administered
only if prescribed by a physician. Helsinn Healthcare is working to
ensure that a full comprehensive review of all safety data is
completed as soon as possible.
In the meanwhile, it is worth highlighting that the prescription
and use in compliance with the approved SPC are fundamental to
guarantee that nimesulide continues to stand as an effective and safe
therapeutic choice for the treatment of various conditions
characterized by acute pain.
About HELSINN HEALTHCARE
HELSINN HEALTHCARE SA, a privately owned pharmaceutical group with
headquarters in Switzerland. HELSINN's core business is the licensing
of pharmaceuticals in various therapeutic areas (inflammation,
gastroenterology, oncology and supportive care). The company's
business strategy is to in-license early stage new chemical entities
and complete their development from the performance of
pre-clinical/clinical studies and CMC development to the attainment
of market approvals in strategic markets (U.S. and Europe). HELSINN's
products are eventually out-licensed to its marketing partners for
distribution. The active pharmaceutical ingredients and the finished
dosage forms are manufactured at HELSINN's cGMP facilities and
supplied worldwide to its customers.  For more information about
HELSINN, please visit the company's Web site at www.helsinn.com.

Contact:

Massimo Tosi
M. Chem. Pharm., Senior Manager, Commercial Operations
Tel.: +41/91/985'21'14
E-Mail: mto@helsinn.com
Mobile: +41/79/701'49'61

Plus de actualités: Helsinn Healthcare SA
Plus de actualités: Helsinn Healthcare SA