File talk:Metamizole (Dipyrone) Availability World Map.svg
Contributing
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If you are not comfortable editing the SVG file, feel free to suggest changes here. It's much preferable if you can provide some source, even if it is not in English, or even if it is not supported by Google translate. —Arthurfragoso (talk) 03:34, 17 February 2022 (UTC)
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Arabic Countries
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I'm skeptical of the primary source I used that list some Arabic countries as having it banned: https://accp1.onlinelibrary.wiley.com/doi/full/10.1002/jcph.1512
I found some websites in Persian or Arabic Language that mentions "Analgin" (آنالژین), but those are not good source. (I had to use Google Translate)
https://fa.medicinebiweekly.com/10792116-antipyretic-drugs-in-pediatrics
https://fa.everaoh.com/analgin-%D8%A8%D8%B1%D8%A7%DB%8C-%D8%B3%D8%B1%D8%AF%D8%B1%D8%AF/
— Arthurfragoso (talk) 03:37, 18 February 2022 (UTC)
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Details from UN source
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"Consolidated list of products whose consumption and/or sale have been banned, withdrawn, severely restricted or not approved by Governments. Pharmaceuticals"
8th issue - in French - https://digitallibrary.un.org/record/523535/files/ST_ESA_282_FR.pdf
AUS - 1965 - "The Ministry of Health has banned the import of noramidopyrine sodium methanesulfonate (metamizole sodium)."
NOR - 1976 - "Withdrawn from the market."
PHL - 1977 - "May only be used as a measure of last resort in severe, life-threatening cases and when less toxic antipyretic preparations and other treatment modalities have failed or are not tolerated, provided the patient is monitored and of appropriate control. The package leaflet must contain complete information and a warning concerning in particular the risk of fatal agranulocytosis from this medicinal product. Available by prescription only."
USA - 27 jun 1977 - withdraw from market and banned for export "This antipyretic analgesic drug has been shown to be effective in the treatment of febrile states but it has been withdrawn from the market and banned from export by the Food and Drug Administration following cases of agranulocytosis (sometimes fatal blood diseases) associated with its use. The Director of the Bureau of Drugs has found that agranulocytosene can be effectively prevented by frequent examination of patients because its occurrence may occur within hours of administration of the drug to a susceptible subject. In its decision, the FDA cites the existence of effective oral preparations (eg acetylsalicylic acid and paracetamol) and concludes that the risks associated with this drug far outweigh its benefits, including in the treatment of Hodgkin's disease and analogous malignancies."
KWT - 1978 - "Approval has been withdrawn from all preparations, except for injectable forms which can still be used in emergencies only."
ITA - 1979 - "Injection preparations containing a dose greater than 1 g and intravenous preparations containing this substance in combination have been withdrawn from the market. The instructions for preparations currently on the market carry a warning concerning the risk of fatal accidents due to hypersensitivity."
DNK - 1979 - "Preparations containing metamizole sodium are prohibited for systemic administration due to a potential risk of fatal agranulocytosis."
SAU - 1980 - "All preparations containing metamizole sodium have been banned following several reported cases of anaphylactic shock"
ARE - 1981 - "Pharmaceutical preparations containing metamizole sodium are prohibited"
SDN - 1982 - "The Ministry of Health no longer authorizes the placing on the market of metamizole sodium except for parenteral preparations for limited use."
BGD - 1982 - "Banned in the form of oral drops and tablets due to the high incidence of adverse effects and the availability of alternative drugs with better guarantees of safety. This substance can still be injected alone in the context of terminal care, as a medicine for restricted and specialized use."
EGY - 1983 - "Following certain cases of anaphylactic shock, no authorization will be issued for injectable preparations containing more than 1 g of this substance."
ISR - 1985 - "Single-dose combined preparations of metamizole sodium are not approved for Marketing Authorisation. Single-dose injectable preparations can only be administered in hospitals and clinics with resuscitation equipment (in the event of anaphylactic shock). Single-dose enteral preparations can be dispensed without a prescription."
BEL - 1987 - "Preparations containing metamizole sodium having been listed in Table IV of the Regent's Order of 02.06.1946, they can only be administered on prescription. They should be kept in the poison cupboard and affixed with a skull label. Combined with a spasmolytic, this substance can be delivered a maximum of five times in six months on presentation of a renewable prescription."
MYS - 1987 - Ban - "All products containing metamizole sodium have been removed from the market"
DEU - 1987 - "Following regulatory measures taken in January 1983 (see section pyrazolones), the Federal Office of Health has further limited the use of preparations containing metamizole sodium. From January 1, 1987, all preparations are subject to the prescription regime and associated products have been withdrawn from the market."
PAK - 1988 - "All associated pharmaceutical products containing metamizole sodium have been withdrawn."
ESP - 1989 - "The indications for products containing metamizole sodium have been limited to acute post-traumatic or post-surgical pain or abdominal colic and high fever refractory to other antipyretics. All associated products of fixed composition and containing metamizole have been withdrawn, except those in which it is associated with a spasmolytic"
GHA - 1989 - Ban - "Products containing metamizole sodium or its salts have been banned"
NLD - 1990 - "In view of reports of cases of agranulocytosis, the manufacturers have agreed to voluntarily remove metamizole sodium from the associated formulations"
CHE - 1992 - "Products containing metamizole sodium have been subject to stricter prescription rules"
LKA - 1992 - "The Ministry of Health has withdrawn pharmaceutical products containing metamizole sodium (injection formulation) from sale. This measure was based on the fact that these products risked inducing destruction of the bone marrow."
THA - 1992 - "The Ministry of Public Health has reviewed the technical information for pharmaceutical products that contain the painkiller pyrazalonemetamizole sodium (dipyrone) to include a warning about the risks of agranulocytosis and impaired immune system, and finally, to limit its use to acute pain even to patients insensitive to aspirin or paracetamol. The classification of the drug has been changed and its delivery is now possible only by prescription. Its use has also been prohibited in the form of combined products, for example antispasmodic preparations and anticoryza preparations."
NPL - 1997 - Ban - "Health authorities have banned the import, manufacture, sale, distribution and storage of metamizole sodium alone or in combination. This action has been taken based on safety concerns regarding this product."
SYR - 1998 - "The Supreme Technical Committee and the Ministry of Health have ordered all local pharmaceutical manufacturers to stop the manufacture of metamizole sodium (dipyrone) ampoules (with immediate effect)." - what about pills?
YEM - 1998 - Ban -"The Supreme Bureau of Pharmaceuticals and Medical Devices has ordered the withdrawal of all metamizole sodium formulations due to a potential risk of anaphylactic shock and agranulocytosis."
ZWE - 1998 - Ban - "The Medicines Control Board has canceled the registration of all products containing metamizole sodium (dipyrone) due to the potential risk of fatal agranulocytosis."
SWE - 1999 - Ban - "The Medical Products Control Agency has suspended the marketing authorization for metamizole sodium, with effect from 28 April 1999. This decision is based on the observation of a higher than expected number of reported cases of agranulocytosis in Sweden since 1996 (1 in 1700)."
MAR - 2000 - Ban - "The Ministry of Public Health has decided to suspend the marketing authorization for products containing metamizole sodium on the recommendation of the National Pharmacovigilance Advisory Commission. This recommendation followed the conclusions of an official study demonstrating the serious adverse reactions associated with this product."
COL - 2000 - "The Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) of Colombia, attached to the Colombian Ministry of Health, has restricted the use of metamizole, either alone or in combination. These products should be made available only in the event of insufficient efficacy of the other associated products and other therapeutic treatments."
ARM - Ban - "The Medicines and Technologies Regulatory Authority has suspended the marketing authorization for metamizole sodium (tablets and solution). This decision is based on a large amount of information reporting cases of agranulocitosis in Sweden since 1996 and on various dangerous side effects observed."
BHR - Ban - "Preparations containing metamizole sodium have been withdrawn from the market."
GRC - "Preparations containing metamizole sodium have been withdrawn from the market, with the exception of injectable presentations containing a maximum of 1 g, due to the risk of agranulocytosis associated with the use of this medicinal product."
IRL - Ban - "Products containing metamizole sodium have been withdrawn from the market."
MEX - "This product is not approved in pediatric preparations (elixirs, solutions, suspensions, suppositories) due to its toxicity. Other substances must be used in its place."
PER - "The leaflet and the packaging state that this medicine can only be administered on prescription and that it may cause agranulocytosis."
SGP - "Metamizole sodium and related salts are prohibited for import."
SWE - "Preparations containing metamizole sodium have been withdrawn from the market by the manufacturers following consultations concerning adverse reactions such as agranulocytosis."
VEN - "Unauthorized use and sale."
10th issue
Lithuania - 2000 - "The marketing authorization for tablets was not renewed for safety reasons."
14th - https://www.un.org/esa/coordination/CL-14-Final.for.Printing.pdf
Nigeria - 2005 Banned - In view of recorded cases of adverse reactions, the National Agency for Food and Drug Administration and Control (NAFDAC) has warned against the use of all brands of dipyrone drugs (Novalgin, Analgin, Optalgin, Drunalgin, Dr. Meyers Novalmin, Akarin, etc.). With effect from 1 September 205, the Agency will not allow the manufacture and importation of these drugs in any dosage form (injections, tablets and syrups) into the country. Also, with effect from 1st January 2006, the sale and use of all brands of matamizole drugs are banned.
East Timor - 2005 - "To be removed due to reports of agranulocytosis."
Serbia - 2005 - "The labels of all registered products containing metamizole are required to include the boxed warning: "The use is not recommended in children and adolescents under the age of 18 years." The use of products containing metamizole has been restricted to short-term treatment of severe post-traumatic and post-surgical pains where other non-opioid analgesics show ineffectiveness. These measures are based on postmarketing reports of agranulocytosis (including one case with fatal outcome) associated with the use of metamizole, regulatory measures taken worldwide, and relevant medical literature."
France - 2006 - "Dipyone/metamizole/noramidopyrin containing products are no longer marketed due to negative benefit/risk evaluation."
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