About aminophenazone
Aminophenazone manufacturers today supply mainly API for diagnostic and veterinary use and for the few markets where it is still sold. Aminophenazone (aminopyrine, Pyramidon) is a pyrazolone analgesic and antipyretic introduced more than a century ago. Because it can cause life-threatening agranulocytosis, it has been withdrawn or banned in most industrialised countries. Pharmaceutical companies should check national status carefully before sourcing aminophenazone.
Aminophenazone key facts
|
Property |
Aminophenazone |
|---|---|
|
INN |
Aminophenazone |
|
Other names |
Aminopyrine; amidopyrine; Pyramidon |
|
Chemical name |
4-dimethylamino-1,5-dimethyl-2-phenyl-3-pyrazolone |
|
Molecular formula / weight |
C13H17N3O / 231.3 g/mol |
|
CAS number |
58-15-1 |
|
ATC code |
N02BB03 (single); N02BB53 and N02BB73 (combinations) |
|
Drug class |
Pyrazolone analgesic and antipyretic |
|
Main safety risk |
Agranulocytosis and aplastic anaemia; possible carcinogenic nitrosamine formation |
|
Withdrawals |
Withdrawn or banned in most industrialised countries; e.g. France and Thailand (1999) |
|
Remaining uses |
Some markets in Asia, Africa and Latin America; veterinary products; aminopyrine breath test for liver function |
|
Dosage forms (historical) |
Tablets, oral solutions, suppositories; combinations |
|
Patent status |
Off-patent |
Aminophenazone manufacturers and licensing history
Aminophenazone was introduced as Pyramidon in the 1890s and was widely used for pain and fever. In the 1930s, it was linked to agranulocytosis, a dangerous loss of white blood cells. Later concerns about cancer-causing nitrosamines added to the risks.
As a result, aminophenazone has been banned or withdrawn in most industrialised countries. France and Thailand withdrew it in 1999. However, it remains available in parts of the Far East, Africa and Latin America, and has been found as an undeclared ingredient in some herbal preparations.
Today, aminophenazone API is used mainly in veterinary products, in the labelled aminopyrine breath test for liver function, and in markets where it is still registered. Buyers should confirm the national legal status, GMP status and intended use before sourcing.
Aminophenazone dosage forms and dossier types
Aminophenazone was historically sold as tablets, oral solutions, suppositories and combinations. Licensing interest today is limited to permitted markets and non-human uses.
|
Form |
Strengths |
Typical dossier |
Notes |
|---|---|---|---|
|
Aminophenazone API |
Bulk |
Supplier documentation |
Check national legal status |
|
Aminophenazone combinations (human) |
Per national MA |
National dossier |
Only where still authorised |
|
Veterinary aminophenazone products |
Per national MA |
Veterinary dossier |
Some Asian markets |
|
13C-aminopyrine (diagnostic) |
Per test |
Diagnostic registration |
Liver function breath test |
|
Target market |
Dossier format |
Key requirement |
|---|---|---|
|
EU, US, most industrialised countries |
Not applicable |
Withdrawn or not approved for human use |
|
Some Asian, African, Latin American markets |
National |
Confirm current registration status |
|
Veterinary markets |
Veterinary dossier |
National veterinary rules |
Aminophenazone regulatory and patent status
Aminophenazone has been withdrawn or banned for human use in most industrialised countries because of agranulocytosis. The WHO has noted that aminophenazone products were formally withdrawn in many countries. It remains on the market in some countries and in veterinary use. Buyers must confirm the legal status in each target market before any development.
Aminophenazone mechanism of action and therapeutic use
Aminophenazone inhibits prostaglandin production, which reduces pain, fever and inflammation. It was formerly used for pain, fever and rheumatic conditions. Because safer alternatives exist, it is no longer recommended for human use in most countries. Its metabolism by the liver is used in the aminopyrine breath test to measure liver function.
Aminophenazone licensing and sourcing
Aminophenazone suppliers typically offer API supply for permitted human, veterinary and diagnostic uses. Buyers usually compare GMP status, intended use, legal status and territory availability. Current offers and supplier contacts are listed among the aminophenazone manufacturers on Pipelinepharma.
Frequently asked questions about aminophenazone
Is aminophenazone still used? Aminophenazone has been withdrawn in most industrialised countries but is still sold in parts of Asia, Africa and Latin America, and in veterinary products.
Why was aminophenazone withdrawn? Aminophenazone was withdrawn because it can cause agranulocytosis, a life-threatening loss of white blood cells. There were also concerns about cancer-causing nitrosamine formation.
What is the difference between aminophenazone and metamizole? Both are pyrazolone analgesics. Metamizole (dipyrone) is still approved in some European countries, while aminophenazone has been withdrawn in most.
What is the aminopyrine breath test? The aminopyrine breath test uses carbon-13-labelled aminophenazone to measure liver function, based on how quickly the liver breaks it down.
Can aminophenazone be registered in the EU? No. Aminophenazone is not authorised for human use in the EU, and new registrations are not expected.
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