Nimesulide
Encyclopedia
Nimesulide is a relatively COX-2 selective
, non-steroidal anti-inflammatory drug
(NSAID) with analgesic
and antipyretic
properties. Its approved indications are the treatment
of acute pain, the symptom
atic treatment of osteoarthritis
and primary dysmenorrhoea in adolescents and adults above 12 years old. Due to concerns about the risk of hepatotoxicity
, nimesulide has been withdrawn from market in many countries.
for the first time as Aulin and Mesulid in 1985 and is presently available in more than 50 countries worldwide, among others France
, Portugal
, Greece
, Switzerland
, Belgium
, Mexico
and Brazil
. Nimesulide has never been filed for Food and Drug Administration (FDA) evaluation in the United States
, where it is not marketed.
(EMA) reported that the benefit/risk profile of nimesulide containing medicinal products (Aulin, Mesulide, Nimed and associated product names) for systemic and topical use is favourable and that Marketing Authorisations should be maintained/granted. The CPMP recommended to restrict the use of nimesulide to the indications of treatment of acute pain, symptomatic treatment of painful osteoarthritis and primary dysmenorrhoea for the systemic formulations and symptomatic relief of pain associated with sprains and acute tendinitis for the topical formulation.
Alembic
Ltd. issued a circular asking wholesalers and retailers to withdraw all stocks of Nimegesic Drops (a pediatric dosage form of nimesulide) in 2003, consistent with the fact that nimesulide is, like most NSAIDs, not indicated in children.
From 2011 onwards, it has been totally banned in India
.
Nimesulide is a relatively COX-2 selective
, non-steroidal anti-inflammatory drug
(NSAID) with analgesic
and antipyretic
properties. Its approved indications are the treatment
of acute pain, the symptom
atic treatment of osteoarthritis
and primary dysmenorrhoea in adolescents and adults above 12 years old. Due to concerns about the risk of hepatotoxicity
, nimesulide has been withdrawn from market in many countries.http://www.medindia.net/news/Unsafe-Drugs-Banned-79989-1.htm
for the first time as Aulin and Mesulid in 1985 and is presently available in more than 50 countries worldwide, among others France
, Portugal
, Greece
, Switzerland
, Belgium
, Mexico
and Brazil
. Nimesulide has never been filed for Food and Drug Administration (FDA) evaluation in the United States
, where it is not marketed.
(EMA) reported that the benefit/risk profile of nimesulide containing medicinal products (Aulin, Mesulide, Nimed and associated product names) for systemic and topical use is favourable and that Marketing Authorisations should be maintained/granted. The CPMP recommended to restrict the use of nimesulide to the indications of treatment of acute pain, symptomatic treatment of painful osteoarthritis and primary dysmenorrhoea for the systemic formulations and symptomatic relief of pain associated with sprains and acute tendinitis for the topical formulation.European Commission CPMP favourable opinion on nimesulide
Alembic
Ltd. issued a circular asking wholesalers and retailers to withdraw all stocks of Nimegesic Drops (a pediatric dosage form of nimesulide) in 2003, consistent with the fact that nimesulide is, like most NSAIDs, not indicated in children.The end begins
From 2011 onwards, it has been totally banned in India
.
Nimesulide is a relatively COX-2 selective
, non-steroidal anti-inflammatory drug
(NSAID) with analgesic
and antipyretic
properties. Its approved indications are the treatment
of acute pain, the symptom
atic treatment of osteoarthritis
and primary dysmenorrhoea in adolescents and adults above 12 years old. Due to concerns about the risk of hepatotoxicity
, nimesulide has been withdrawn from market in many countries.http://www.medindia.net/news/Unsafe-Drugs-Banned-79989-1.htm
for the first time as Aulin and Mesulid in 1985 and is presently available in more than 50 countries worldwide, among others France
, Portugal
, Greece
, Switzerland
, Belgium
, Mexico
and Brazil
. Nimesulide has never been filed for Food and Drug Administration (FDA) evaluation in the United States
, where it is not marketed.
(EMA) reported that the benefit/risk profile of nimesulide containing medicinal products (Aulin, Mesulide, Nimed and associated product names) for systemic and topical use is favourable and that Marketing Authorisations should be maintained/granted. The CPMP recommended to restrict the use of nimesulide to the indications of treatment of acute pain, symptomatic treatment of painful osteoarthritis and primary dysmenorrhoea for the systemic formulations and symptomatic relief of pain associated with sprains and acute tendinitis for the topical formulation.European Commission CPMP favourable opinion on nimesulide
Alembic
Ltd. issued a circular asking wholesalers and retailers to withdraw all stocks of Nimegesic Drops (a pediatric dosage form of nimesulide) in 2003, consistent with the fact that nimesulide is, like most NSAIDs, not indicated in children.The end begins
From 2011 onwards, it has been totally banned in India
.
and other media outlets reported that a top-ranking official at Italy's medicines agency AIFA had been filmed by police while accepting bribes from employees of pharmaceutical companies.«Mazzette per evitare i controlli sull'Aulin». Mario Pappagallo, Corriere della Sera, 23 May 2008Italian medicines agency officials arrested in corruption probe. Manufacturing Chemist The money was allegedly being paid to ensure that certain drugs (nimesulide-containing Aulin being the most prominent) would be spared scrutiny from the drugs watchdog. The investigation had started in 2005 following suspicions that some AIFA drug tests had been faked. Eight arrests were made. Following this, concerns about nimesulide hepatotoxicity became more widely reported by the Italian media. A government minister ordered an inquiry. Presently, nimesulide can be bought carrying a prescription from a physician, that is kept as a receipt at the chemist shop, nominally allowing strong control over selling.
The original manufacturer of Nimesulide is Helsinn Healthcare SA, Switzerland, which acquired the rights for the drug in 1976. After the patent protection had terminated, a number of other companies have started production and marketing of Nimesulide.
In 2002, Finland and Spain withdrew nimesulide from the market following reports of serious liver damage. Cases including 2 deaths had also been reported in France at the time. Ireland decided to withdraw nimesulide from the market in 2007.
and phenyl alanine, contained therapeutic doses of Nimesulide. This was thus probably the reason for the serious side effects of this preparation.http://www.lakemedelsverket.se/Tpl/NewsPage____8325.aspx (Swedish) Identical or similar preparations containing turmeric tainted with nimesulide have been marketed in Denmark, Finland and in the UK under the brand name "Miradin".http://www.food.gov.uk/enforcement/alerts/2009/mar/miradinfortodol
In 2010 Kurt Donsbach
, the inventor and manufacturer of Fortodols content, pleaded guilty to selling misbranded drugs. Providing supplements with Nimesulide was one of the charges he admitted to.
Nimesulide has never been approved for use in countries like USA, UK, Canada, Australia New Zealand, Japan and other countries in view of concerns over its safety profile. Ireland and Singapore decided to withdraw nimesulide from the market in 2007.
The Therapeutics Initiative website mentions:
"The European Medicines Agency has confirmed the hepatic risks associated with nimesulide in 2007, but merely limited the duration of treatment, leaving patients exposed to an unjustifiable fatal risk. These half-hearted measures are all the more unacceptable since numerous other available NSAIDs are just as effective and less dangerous."
A recent evaluation from EMEA (the European Medicines Agency) concluded that the overall benefit/risk profile of nimesulide is favourable and in line with that of the other NSAIDs (such as for example, diclofenac
, ibuprofen
, naproxen
).
Nimesulide undergoes extensive biotransformation, mainly to 4-hydroxynimesulide (which also appears to be biologically active).
Food, gender and advanced age have negligible effects on nimesulide pharmacokinetics.
Moderate renal impairment does not necessitate dosage adjustment while patients with severe renal impairment or hepatic impairment are contraindicated.Microsoft Word - opnh.P.Nimesulide .EMEA-CPMP-3086-03-en-Final.doc
Nimesulide has a relatively rapid onset of action, with meaningful reductions in pain and inflammation observed within 15 minutes from drug intake.
As many as almost 498 million patients have been treated with nimesulide from its launch until today.
The therapeutic effects of Nimesulide are the result of its complete mode of action which targets a number of key mediators of the inflammatory process such as: COX-2 mediated prostaglandins, free radicals, proteolytic enzymes and histamine.
Clinical evidence is available to support a particularly good profile in terms of gastrointestinal tolerability.
As all anti-inflammatory drugs, it should be taken in compliance with the recommendations included in the patient leaflet.
(damaging to the liver) in rare but unpredictable cases and should be taken with care. The patient information leaflet informs that the use of nimesulide in children under the age of 12 is contraindicated.
The drug has certain side effects, that can affect individuals in different ways. The following are some of the side effects, that are often associated with the drug:
Women should use the drug with caution during lactation and it is contraindicated during pregnancy.http://www.pharmaceutical-drug-manufacturers.com/pharmaceutical-drugs/nimesulide.html
COX-2 inhibitor
COX-2 selective inhibitor is a form of non-steroidal anti-inflammatory drug that directly targets COX-2, an enzyme responsible for inflammation and pain. Targeting selectivity for COX-2 reduces the risk of peptic ulceration, and is the main feature of celecoxib, rofecoxib and other members of this...
, non-steroidal anti-inflammatory drug
Non-steroidal anti-inflammatory drug
Nonsteroidal anti-inflammatory drugs, usually abbreviated to NSAIDs or NAIDs, but also referred to as nonsteroidal anti-inflammatory agents/analgesics or nonsteroidal Anti-inflammatory medicines , are drugs with analgesic and antipyretic effects and which have, in higher doses, anti-inflammatory...
(NSAID) with analgesic
Analgesic
An analgesic is any member of the group of drugs used to relieve pain . The word analgesic derives from Greek an- and algos ....
and antipyretic
Antipyretic
Antipyretics ; an-tee-pahy-ret-iks; from the Greek anti, against, and pyreticus, are drugs or herbs that reduce fever. Normally, they will not lower body temperature if one does not have a fever. Antipyretics cause the hypothalamus to override an interleukin-induced increase in temperature...
properties. Its approved indications are the treatment
Pharmacotherapy
Pharmacotherapy is the treatment of disease through the administration of drugs. As such, it is considered part of the larger category of therapy....
of acute pain, the symptom
Symptom
A symptom is a departure from normal function or feeling which is noticed by a patient, indicating the presence of disease or abnormality...
atic treatment of osteoarthritis
Osteoarthritis
Osteoarthritis also known as degenerative arthritis or degenerative joint disease, is a group of mechanical abnormalities involving degradation of joints, including articular cartilage and subchondral bone. Symptoms may include joint pain, tenderness, stiffness, locking, and sometimes an effusion...
and primary dysmenorrhoea in adolescents and adults above 12 years old. Due to concerns about the risk of hepatotoxicity
Hepatotoxicity
Hepatotoxicity implies chemical-driven liver damage.The liver plays a central role in transforming and clearing chemicals and is susceptible to the toxicity from these agents. Certain medicinal agents, when taken in overdoses and sometimes even when introduced within therapeutic ranges, may injure...
, nimesulide has been withdrawn from market in many countries.
History
It was launched in ItalyItaly
Italy , officially the Italian Republic languages]] under the European Charter for Regional or Minority Languages. In each of these, Italy's official name is as follows:;;;;;;;;), is a unitary parliamentary republic in South-Central Europe. To the north it borders France, Switzerland, Austria and...
for the first time as Aulin and Mesulid in 1985 and is presently available in more than 50 countries worldwide, among others France
France
The French Republic , The French Republic , The French Republic , (commonly known as France , is a unitary semi-presidential republic in Western Europe with several overseas territories and islands located on other continents and in the Indian, Pacific, and Atlantic oceans. Metropolitan France...
, Portugal
Portugal
Portugal , officially the Portuguese Republic is a country situated in southwestern Europe on the Iberian Peninsula. Portugal is the westernmost country of Europe, and is bordered by the Atlantic Ocean to the West and South and by Spain to the North and East. The Atlantic archipelagos of the...
, Greece
Greece
Greece , officially the Hellenic Republic , and historically Hellas or the Republic of Greece in English, is a country in southeastern Europe....
, Switzerland
Switzerland
Switzerland name of one of the Swiss cantons. ; ; ; or ), in its full name the Swiss Confederation , is a federal republic consisting of 26 cantons, with Bern as the seat of the federal authorities. The country is situated in Western Europe,Or Central Europe depending on the definition....
, Belgium
Belgium
Belgium , officially the Kingdom of Belgium, is a federal state in Western Europe. It is a founding member of the European Union and hosts the EU's headquarters, and those of several other major international organisations such as NATO.Belgium is also a member of, or affiliated to, many...
, Mexico
Mexico
The United Mexican States , commonly known as Mexico , is a federal constitutional republic in North America. It is bordered on the north by the United States; on the south and west by the Pacific Ocean; on the southeast by Guatemala, Belize, and the Caribbean Sea; and on the east by the Gulf of...
and Brazil
Brazil
Brazil , officially the Federative Republic of Brazil , is the largest country in South America. It is the world's fifth largest country, both by geographical area and by population with over 192 million people...
. Nimesulide has never been filed for Food and Drug Administration (FDA) evaluation in the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
, where it is not marketed.
European Medicines Agency reports favourable benefit/risk ratio
On August 1, 2003 the Committee for Proprietary Medicinal Products (CPMP) of the European Medicines AgencyEuropean Medicines Agency
The European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
(EMA) reported that the benefit/risk profile of nimesulide containing medicinal products (Aulin, Mesulide, Nimed and associated product names) for systemic and topical use is favourable and that Marketing Authorisations should be maintained/granted. The CPMP recommended to restrict the use of nimesulide to the indications of treatment of acute pain, symptomatic treatment of painful osteoarthritis and primary dysmenorrhoea for the systemic formulations and symptomatic relief of pain associated with sprains and acute tendinitis for the topical formulation.
Alembic
Alembic
An alembic is an alchemical still consisting of two vessels connected by a tube...
Ltd. issued a circular asking wholesalers and retailers to withdraw all stocks of Nimegesic Drops (a pediatric dosage form of nimesulide) in 2003, consistent with the fact that nimesulide is, like most NSAIDs, not indicated in children.
Central Drugs Standard Control Organization of India bans Nimesulide
Several reports have been made of adverse drug reactions in India. On Feb 12, 2011, Express India reported that the Union Ministry of Health and Family Welfare had finally decided to ban the pediatric use of the analgesic, Nimesulide suspension.From 2011 onwards, it has been totally banned in India
India
India , officially the Republic of India , is a country in South Asia. It is the seventh-largest country by geographical area, the second-most populous country with over 1.2 billion people, and the most populous democracy in the world...
.
Irish Medicines Board (IMB) suspends Nimesulide containing drugs (15 May 2007)
The Irish Medicines Board (IMB) has decided to suspend Nimesulide from the Irish market and refer it to the EU Committee for Human Medicinal Products (CHMP) for a review of its benefit/risk profile. The decision is due to the reporting of six (6) cases of potentially related liver failures to the IMB by the National Liver Transplant Unit, St Vincent Hospital. These cases occurred in the period from 1999 to 2006.Nimesulide is a relatively COX-2 selective
COX-2 inhibitor
COX-2 selective inhibitor is a form of non-steroidal anti-inflammatory drug that directly targets COX-2, an enzyme responsible for inflammation and pain. Targeting selectivity for COX-2 reduces the risk of peptic ulceration, and is the main feature of celecoxib, rofecoxib and other members of this...
, non-steroidal anti-inflammatory drug
Non-steroidal anti-inflammatory drug
Nonsteroidal anti-inflammatory drugs, usually abbreviated to NSAIDs or NAIDs, but also referred to as nonsteroidal anti-inflammatory agents/analgesics or nonsteroidal Anti-inflammatory medicines , are drugs with analgesic and antipyretic effects and which have, in higher doses, anti-inflammatory...
(NSAID) with analgesic
Analgesic
An analgesic is any member of the group of drugs used to relieve pain . The word analgesic derives from Greek an- and algos ....
and antipyretic
Antipyretic
Antipyretics ; an-tee-pahy-ret-iks; from the Greek anti, against, and pyreticus, are drugs or herbs that reduce fever. Normally, they will not lower body temperature if one does not have a fever. Antipyretics cause the hypothalamus to override an interleukin-induced increase in temperature...
properties. Its approved indications are the treatment
Pharmacotherapy
Pharmacotherapy is the treatment of disease through the administration of drugs. As such, it is considered part of the larger category of therapy....
of acute pain, the symptom
Symptom
A symptom is a departure from normal function or feeling which is noticed by a patient, indicating the presence of disease or abnormality...
atic treatment of osteoarthritis
Osteoarthritis
Osteoarthritis also known as degenerative arthritis or degenerative joint disease, is a group of mechanical abnormalities involving degradation of joints, including articular cartilage and subchondral bone. Symptoms may include joint pain, tenderness, stiffness, locking, and sometimes an effusion...
and primary dysmenorrhoea in adolescents and adults above 12 years old. Due to concerns about the risk of hepatotoxicity
Hepatotoxicity
Hepatotoxicity implies chemical-driven liver damage.The liver plays a central role in transforming and clearing chemicals and is susceptible to the toxicity from these agents. Certain medicinal agents, when taken in overdoses and sometimes even when introduced within therapeutic ranges, may injure...
, nimesulide has been withdrawn from market in many countries.http://www.medindia.net/news/Unsafe-Drugs-Banned-79989-1.htm
History
It was launched in ItalyItaly
Italy , officially the Italian Republic languages]] under the European Charter for Regional or Minority Languages. In each of these, Italy's official name is as follows:;;;;;;;;), is a unitary parliamentary republic in South-Central Europe. To the north it borders France, Switzerland, Austria and...
for the first time as Aulin and Mesulid in 1985 and is presently available in more than 50 countries worldwide, among others France
France
The French Republic , The French Republic , The French Republic , (commonly known as France , is a unitary semi-presidential republic in Western Europe with several overseas territories and islands located on other continents and in the Indian, Pacific, and Atlantic oceans. Metropolitan France...
, Portugal
Portugal
Portugal , officially the Portuguese Republic is a country situated in southwestern Europe on the Iberian Peninsula. Portugal is the westernmost country of Europe, and is bordered by the Atlantic Ocean to the West and South and by Spain to the North and East. The Atlantic archipelagos of the...
, Greece
Greece
Greece , officially the Hellenic Republic , and historically Hellas or the Republic of Greece in English, is a country in southeastern Europe....
, Switzerland
Switzerland
Switzerland name of one of the Swiss cantons. ; ; ; or ), in its full name the Swiss Confederation , is a federal republic consisting of 26 cantons, with Bern as the seat of the federal authorities. The country is situated in Western Europe,Or Central Europe depending on the definition....
, Belgium
Belgium
Belgium , officially the Kingdom of Belgium, is a federal state in Western Europe. It is a founding member of the European Union and hosts the EU's headquarters, and those of several other major international organisations such as NATO.Belgium is also a member of, or affiliated to, many...
, Mexico
Mexico
The United Mexican States , commonly known as Mexico , is a federal constitutional republic in North America. It is bordered on the north by the United States; on the south and west by the Pacific Ocean; on the southeast by Guatemala, Belize, and the Caribbean Sea; and on the east by the Gulf of...
and Brazil
Brazil
Brazil , officially the Federative Republic of Brazil , is the largest country in South America. It is the world's fifth largest country, both by geographical area and by population with over 192 million people...
. Nimesulide has never been filed for Food and Drug Administration (FDA) evaluation in the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
, where it is not marketed.
European Medicines Agency reports favourable benefit/risk ratio
On August 1, 2003 the Committee for Proprietary Medicinal Products (CPMP) of the European Medicines AgencyEuropean Medicines Agency
The European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
(EMA) reported that the benefit/risk profile of nimesulide containing medicinal products (Aulin, Mesulide, Nimed and associated product names) for systemic and topical use is favourable and that Marketing Authorisations should be maintained/granted. The CPMP recommended to restrict the use of nimesulide to the indications of treatment of acute pain, symptomatic treatment of painful osteoarthritis and primary dysmenorrhoea for the systemic formulations and symptomatic relief of pain associated with sprains and acute tendinitis for the topical formulation.European Commission CPMP favourable opinion on nimesulide
Alembic
Alembic
An alembic is an alchemical still consisting of two vessels connected by a tube...
Ltd. issued a circular asking wholesalers and retailers to withdraw all stocks of Nimegesic Drops (a pediatric dosage form of nimesulide) in 2003, consistent with the fact that nimesulide is, like most NSAIDs, not indicated in children.The end begins
Central Drugs Standard Control Organization of India bans Nimesulide
Several reports have been made of adverse drug reactions in India.Safety of nimesulide. CD ROM, Appropriate Use of Antipyretics / Analgesics in Children, Health Informatics, New Delhi, 2004. On Feb 12, 2011, Express India reported that the Union Ministry of Health and Family Welfare had finally decided to ban the pediatric use of the analgesic, Nimesulide suspension.From 2011 onwards, it has been totally banned in India
India
India , officially the Republic of India , is a country in South Asia. It is the seventh-largest country by geographical area, the second-most populous country with over 1.2 billion people, and the most populous democracy in the world...
.
Irish Medicines Board (IMB) suspends Nimesulide containing drugs (15 May 2007)
The Irish Medicines Board (IMB) has decided to suspend Nimesulide from the Irish market and refer it to the EU Committee for Human Medicinal Products (CHMP) for a review of its benefit/risk profile. The decision is due to the reporting of six (6) cases of potentially related liver failures to the IMB by the National Liver Transplant Unit, St Vincent Hospital. These cases occurred in the period from 1999 to 2006.Nimesulide is a relatively COX-2 selective
COX-2 inhibitor
COX-2 selective inhibitor is a form of non-steroidal anti-inflammatory drug that directly targets COX-2, an enzyme responsible for inflammation and pain. Targeting selectivity for COX-2 reduces the risk of peptic ulceration, and is the main feature of celecoxib, rofecoxib and other members of this...
, non-steroidal anti-inflammatory drug
Non-steroidal anti-inflammatory drug
Nonsteroidal anti-inflammatory drugs, usually abbreviated to NSAIDs or NAIDs, but also referred to as nonsteroidal anti-inflammatory agents/analgesics or nonsteroidal Anti-inflammatory medicines , are drugs with analgesic and antipyretic effects and which have, in higher doses, anti-inflammatory...
(NSAID) with analgesic
Analgesic
An analgesic is any member of the group of drugs used to relieve pain . The word analgesic derives from Greek an- and algos ....
and antipyretic
Antipyretic
Antipyretics ; an-tee-pahy-ret-iks; from the Greek anti, against, and pyreticus, are drugs or herbs that reduce fever. Normally, they will not lower body temperature if one does not have a fever. Antipyretics cause the hypothalamus to override an interleukin-induced increase in temperature...
properties. Its approved indications are the treatment
Pharmacotherapy
Pharmacotherapy is the treatment of disease through the administration of drugs. As such, it is considered part of the larger category of therapy....
of acute pain, the symptom
Symptom
A symptom is a departure from normal function or feeling which is noticed by a patient, indicating the presence of disease or abnormality...
atic treatment of osteoarthritis
Osteoarthritis
Osteoarthritis also known as degenerative arthritis or degenerative joint disease, is a group of mechanical abnormalities involving degradation of joints, including articular cartilage and subchondral bone. Symptoms may include joint pain, tenderness, stiffness, locking, and sometimes an effusion...
and primary dysmenorrhoea in adolescents and adults above 12 years old. Due to concerns about the risk of hepatotoxicity
Hepatotoxicity
Hepatotoxicity implies chemical-driven liver damage.The liver plays a central role in transforming and clearing chemicals and is susceptible to the toxicity from these agents. Certain medicinal agents, when taken in overdoses and sometimes even when introduced within therapeutic ranges, may injure...
, nimesulide has been withdrawn from market in many countries.http://www.medindia.net/news/Unsafe-Drugs-Banned-79989-1.htm
History
It was launched in ItalyItaly
Italy , officially the Italian Republic languages]] under the European Charter for Regional or Minority Languages. In each of these, Italy's official name is as follows:;;;;;;;;), is a unitary parliamentary republic in South-Central Europe. To the north it borders France, Switzerland, Austria and...
for the first time as Aulin and Mesulid in 1985 and is presently available in more than 50 countries worldwide, among others France
France
The French Republic , The French Republic , The French Republic , (commonly known as France , is a unitary semi-presidential republic in Western Europe with several overseas territories and islands located on other continents and in the Indian, Pacific, and Atlantic oceans. Metropolitan France...
, Portugal
Portugal
Portugal , officially the Portuguese Republic is a country situated in southwestern Europe on the Iberian Peninsula. Portugal is the westernmost country of Europe, and is bordered by the Atlantic Ocean to the West and South and by Spain to the North and East. The Atlantic archipelagos of the...
, Greece
Greece
Greece , officially the Hellenic Republic , and historically Hellas or the Republic of Greece in English, is a country in southeastern Europe....
, Switzerland
Switzerland
Switzerland name of one of the Swiss cantons. ; ; ; or ), in its full name the Swiss Confederation , is a federal republic consisting of 26 cantons, with Bern as the seat of the federal authorities. The country is situated in Western Europe,Or Central Europe depending on the definition....
, Belgium
Belgium
Belgium , officially the Kingdom of Belgium, is a federal state in Western Europe. It is a founding member of the European Union and hosts the EU's headquarters, and those of several other major international organisations such as NATO.Belgium is also a member of, or affiliated to, many...
, Mexico
Mexico
The United Mexican States , commonly known as Mexico , is a federal constitutional republic in North America. It is bordered on the north by the United States; on the south and west by the Pacific Ocean; on the southeast by Guatemala, Belize, and the Caribbean Sea; and on the east by the Gulf of...
and Brazil
Brazil
Brazil , officially the Federative Republic of Brazil , is the largest country in South America. It is the world's fifth largest country, both by geographical area and by population with over 192 million people...
. Nimesulide has never been filed for Food and Drug Administration (FDA) evaluation in the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
, where it is not marketed.
European Medicines Agency reports favourable benefit/risk ratio
On August 1, 2003 the Committee for Proprietary Medicinal Products (CPMP) of the European Medicines AgencyEuropean Medicines Agency
The European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
(EMA) reported that the benefit/risk profile of nimesulide containing medicinal products (Aulin, Mesulide, Nimed and associated product names) for systemic and topical use is favourable and that Marketing Authorisations should be maintained/granted. The CPMP recommended to restrict the use of nimesulide to the indications of treatment of acute pain, symptomatic treatment of painful osteoarthritis and primary dysmenorrhoea for the systemic formulations and symptomatic relief of pain associated with sprains and acute tendinitis for the topical formulation.European Commission CPMP favourable opinion on nimesulide
Alembic
Alembic
An alembic is an alchemical still consisting of two vessels connected by a tube...
Ltd. issued a circular asking wholesalers and retailers to withdraw all stocks of Nimegesic Drops (a pediatric dosage form of nimesulide) in 2003, consistent with the fact that nimesulide is, like most NSAIDs, not indicated in children.The end begins
Central Drugs Standard Control Organization of India bans Nimesulide
Several reports have been made of adverse drug reactions in India.Safety of nimesulide. CD ROM, Appropriate Use of Antipyretics / Analgesics in Children, Health Informatics, New Delhi, 2004. On Feb 12, 2011, Express India reported that the Union Ministry of Health and Family Welfare had finally decided to ban the pediatric use of the analgesic, Nimesulide suspension.From 2011 onwards, it has been totally banned in India
India
India , officially the Republic of India , is a country in South Asia. It is the seventh-largest country by geographical area, the second-most populous country with over 1.2 billion people, and the most populous democracy in the world...
.
Irish Medicines Board (IMB) suspends Nimesulide containing drugs (15 May 2007)
The Irish Medicines Board (IMB) has decided to suspend Nimesulide from the Irish market and refer it to the EU Committee for Human Medicinal Products (CHMP) for a review of its benefit/risk profile. The decision is due to the reporting of six (6) cases of potentially related liver failures to the IMB by the National Liver Transplant Unit, St Vincent Hospital. These cases occurred in the period from 1999 to 2006.IMB Announces Immediate Suspension of the Marketing of Medicines Containing NimesulideSingapore Health Science Authority suspends Nimesulide containing drugs
Pending review of the drug's safety by the EMA, nimesulide has been suspended with immediate effect (June 15, 2007)Channelnewsasia.comhttp://www.hsa.gov.sg/docs/HSAPressRelease_HSASuspendsSalesOfProductsContainingNimesulide_15Jun07.pdfEMA confirms the positive benefit/risk ratio
On September 21, 2007 the EMA released a press release on their review on the liver-related safety of nimesulide. The EMA has concluded that the benefits of these medicines outweigh their risks, but that there is a need to limit the duration of use to ensure that the risk of patients developing liver problems is kept to a minimum. Therefore the EMA has limited the use of systemic formulations (tablets, solutions, suppositories) of nimesulide to 15 days.EMA press release on nimesulide September 2007RTÉ's Prime Time Investigates
On December 3, 2007 Ireland's RTÉ aired an investigative programme highlighting the deadly side effects of Nimesulide and how it has been linked to over 300 cases of liver disease throughout Europe.Bribes allegedly paid in Italy to spare nimesulide from official scrutiny
In May 2008, Italy's leading daily paper Corriere della SeraCorriere della Sera
The Corriere della Sera is an Italian daily newspaper, published in Milan.It is among the oldest and most reputable Italian newspapers. Its main rivals are Rome's La Repubblica and Turin's La Stampa.- History :...
and other media outlets reported that a top-ranking official at Italy's medicines agency AIFA had been filmed by police while accepting bribes from employees of pharmaceutical companies.«Mazzette per evitare i controlli sull'Aulin». Mario Pappagallo, Corriere della Sera, 23 May 2008Italian medicines agency officials arrested in corruption probe. Manufacturing Chemist The money was allegedly being paid to ensure that certain drugs (nimesulide-containing Aulin being the most prominent) would be spared scrutiny from the drugs watchdog. The investigation had started in 2005 following suspicions that some AIFA drug tests had been faked. Eight arrests were made. Following this, concerns about nimesulide hepatotoxicity became more widely reported by the Italian media. A government minister ordered an inquiry. Presently, nimesulide can be bought carrying a prescription from a physician, that is kept as a receipt at the chemist shop, nominally allowing strong control over selling.
The original manufacturer of Nimesulide is Helsinn Healthcare SA, Switzerland, which acquired the rights for the drug in 1976. After the patent protection had terminated, a number of other companies have started production and marketing of Nimesulide.
Prohibition in several European countries
Nimesulide has been prohibited in several other European countries based on the serious hepatotoxicity that has been suspected of causing several hundred deaths.In 2002, Finland and Spain withdrew nimesulide from the market following reports of serious liver damage. Cases including 2 deaths had also been reported in France at the time. Ireland decided to withdraw nimesulide from the market in 2007.
Illicit marketing as "food supplement" in Scandinavia and the UK
After serious medical problems including deaths from the food supplement "Fortodol", analysis demonstrated that in several instances this "food supplement from natural products", declared to contain turmericTurmeric
Turmeric is a rhizomatous herbaceous perennial plant of the ginger family, Zingiberaceae. It is native to tropical South Asia and needs temperatures between 20 °C and 30 °C and a considerable amount of annual rainfall to thrive...
and phenyl alanine, contained therapeutic doses of Nimesulide. This was thus probably the reason for the serious side effects of this preparation.http://www.lakemedelsverket.se/Tpl/NewsPage____8325.aspx (Swedish) Identical or similar preparations containing turmeric tainted with nimesulide have been marketed in Denmark, Finland and in the UK under the brand name "Miradin".http://www.food.gov.uk/enforcement/alerts/2009/mar/miradinfortodol
In 2010 Kurt Donsbach
Kurt Donsbach
Kurt Walter Donsbach is an unlicensed chiropractor and a controversial alternative medicine figure who has twice been convicted of practicing medicine without a license...
, the inventor and manufacturer of Fortodols content, pleaded guilty to selling misbranded drugs. Providing supplements with Nimesulide was one of the charges he admitted to.
Risk of serious liver damage
The International Society of Drug Bulletins (ISDB) deems it unacceptable that nimesulide has been allowed to remain on European and some other markets in the world. This non-steroidal anti-inflammatory drug (NSAID) offers no therapeutic advantage or better gastrointestinal safety compared with other NSAIDs, whereas it exposes patients to a higher risk of fatal hepatic disorders.Nimesulide has never been approved for use in countries like USA, UK, Canada, Australia New Zealand, Japan and other countries in view of concerns over its safety profile. Ireland and Singapore decided to withdraw nimesulide from the market in 2007.
The Therapeutics Initiative website mentions:
"The European Medicines Agency has confirmed the hepatic risks associated with nimesulide in 2007, but merely limited the duration of treatment, leaving patients exposed to an unjustifiable fatal risk. These half-hearted measures are all the more unacceptable since numerous other available NSAIDs are just as effective and less dangerous."
Availability
It is available in a variety of forms: tablets, powder for dissolution in water, suppositories and topical gel (Sulidin® Gel).A recent evaluation from EMEA (the European Medicines Agency) concluded that the overall benefit/risk profile of nimesulide is favourable and in line with that of the other NSAIDs (such as for example, diclofenac
Diclofenac
Diclofenac is a non-steroidal anti-inflammatory drug taken to reduce inflammation and as an analgesic reducing pain in certain conditions....
, ibuprofen
Ibuprofen
Ibuprofen is a nonsteroidal anti-inflammatory drug used for relief of symptoms of arthritis, fever, as an analgesic , especially where there is an inflammatory component, and dysmenorrhea....
, naproxen
Naproxen
Naproxen sodium is a nonsteroidal anti-inflammatory drug commonly used for the reduction of pain, fever, inflammation and stiffness caused by conditions such as:...
).
Trade names
Nimesulide is available through the world as original product with the following trademarks: Sulide, Nimalox, Mesulid, Nilsid (Egypt); Aulin, Ainex, Drexel, Donulide, Edrigyl, Enetra, Eskaflam, Heugan, Mesulid, Minapon, NeRelid, Nexen, Nidolon, Nilden (Mexico); Nimed, Nimedex, Nimesil, Nimulid, Nimutab, Nimdase, Nise (Russia), Nisulid, Nodard Plus, Nicip, Nimcap (India); Novolid, Pain Lock (VIP Pharma India); Relmex (Ecuador); Remisid (Ukraine); Scaflam, Scaflan, Sulidin® (Turkey); Modact-IR (Pakistan);http://www.druginfosys.com/Brand.aspx?Code=10576 Sulidene and Zolan for veterinary use. Many generic and copy-products also exist (Coxtral, Lusemin, Medicox, Nidol, Nimalox, Nimesil, Nimotas, Nimulid, Nizer, Sorini, Ventor, Vionim, Neolide, Willgo among others).Pharmacokinetics
Nimesulide is rapidly absorbed following oral administration.Nimesulide undergoes extensive biotransformation, mainly to 4-hydroxynimesulide (which also appears to be biologically active).
Food, gender and advanced age have negligible effects on nimesulide pharmacokinetics.
Moderate renal impairment does not necessitate dosage adjustment while patients with severe renal impairment or hepatic impairment are contraindicated.Microsoft Word - opnh.P.Nimesulide .EMEA-CPMP-3086-03-en-Final.doc
Nimesulide has a relatively rapid onset of action, with meaningful reductions in pain and inflammation observed within 15 minutes from drug intake.
As many as almost 498 million patients have been treated with nimesulide from its launch until today.
The therapeutic effects of Nimesulide are the result of its complete mode of action which targets a number of key mediators of the inflammatory process such as: COX-2 mediated prostaglandins, free radicals, proteolytic enzymes and histamine.
Clinical evidence is available to support a particularly good profile in terms of gastrointestinal tolerability.
As all anti-inflammatory drugs, it should be taken in compliance with the recommendations included in the patient leaflet.
Side effects
Like most drugs in NSAID category, nimesulide is known to be hepatotoxicHepatotoxicity
Hepatotoxicity implies chemical-driven liver damage.The liver plays a central role in transforming and clearing chemicals and is susceptible to the toxicity from these agents. Certain medicinal agents, when taken in overdoses and sometimes even when introduced within therapeutic ranges, may injure...
(damaging to the liver) in rare but unpredictable cases and should be taken with care. The patient information leaflet informs that the use of nimesulide in children under the age of 12 is contraindicated.
The drug has certain side effects, that can affect individuals in different ways. The following are some of the side effects, that are often associated with the drug:
- Diarrhea
- Vomiting
- Skin rash
- Pruritis
- Dizziness
- Headache
- Bitterness in mouth
Women should use the drug with caution during lactation and it is contraindicated during pregnancy.http://www.pharmaceutical-drug-manufacturers.com/pharmaceutical-drugs/nimesulide.html
External links
- nimesulide.net, by pharmaceutical company Helsinn Healthcare