Following the publication on your website www.pharmabiz.com of several news articles regarding the drug nimesulide, we want to provide you with some detailed information regarding the safety of this NSAID.
We are Helsinn Healthcare, a privately-owned Swiss company based in Lugano, and we are the developer, marketer and original licensor of nimesulide world-wide.
Today, Helsinn's nimesulide is on the market in more than 50 countries through a network of licensees. Helsinn collects and manages wide post marketing surveillance information, based on more than 346 million treatment courses with its original molecule, from the first launch in August 1985 through today.
In more than 18 years of marketing experience nimesulide has proved safe and effective in the symptomatic treatment of a wide range of conditions, including osteoarthritis, painful extra-articular disorders such as tendonitis and bursitis, acute painful inflammatory states of different aetiology such as respiratory tract inflammation, post traumatic inflammation, odontostomatology and dental surgery, post-operative pain and primary dysmenorrhoea.
The drug is among the most prescribed NSAIDs in the world and over 200 clinical trials, involving more than 90,000 patients have also been conducted to assess its efficacy and safety. Many tolerability and post-marketing surveillance studies performed with nimesulide also support the high tolerability of this drug.
In fact from the analysis of data reported in the clinical trials in osteoarthritis and from the post-marketing studies the overall safety profile of Nimesulide is to be considered good, with a low number of gastrointestinal event2.
Liver adverse effects have been reported in a very few cases, and the incidence of hepatic reactions is approximately 0.1 case cut of 100,000 patients treated, thus comparable to the other NSAIDs.
As you know, in Finland on March 18, 2002, the National Medicine Agency (NAM) decided to temporarily suspend nimesulide from the market following the observation of hepatic adverse reactions in patients taking this drug. The Finnish Health Authorities sent an alert to all EU member states and the EMEA decided to initiate the procedure to re-evaluate the risk/benefit ratio for this drug.
No restrictions to the use of nimesulide were recommended by the European Health Authorities to the member states. Despite this, the Spanish Health Authorities also decided the cautionary temporary suspension of nimesulide in this country.
Independently, Turkey also decided for the cautionary temporary suspension of nimesulide even if no increased evidence of hepatic adverse reactions was reported in the country.
No other countries have suspended nimesulide from their markets. And in Australia, Canada, the US, the UK, it is not on the market because the drug is out of patent and Helsinn have decided for economic reasons not to apply for marketing authorization to the regulatory authorities in these countries.
While awaiting the final decision by EMEA/CPMP, which we are confident will be positive for Nimesulide, we confirm that when used according to the indications stated in the approved Summary of Product Characteristics, nimesulide is safe and effective.
Hoping you will accept our statement, we remain with our best regards.
-- The above letter was addressed to the Editor, Pharmabiz .com by Riccardo Bragila, Managing Director, Helsinn Healthcare SA, Lugano, Switzerland