E-DRUG: Nigeria bans dipyrone/metamizol
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[Nigeria has finally joined a long list of countries that have banned dipyrone/metamizole. It has been known for more than 30 years that this drug has serious side effects. Maybe E-druggers can assess whether they also still see a lot of dipyrone use for moderate pain in their countries? See http://www.nafdacnigeria.org/ for Nigeria's drug regulatory website (which is still silent on this ban!) WB]
Dear e-druggers,
Those of us who are familiar with pain management practices in Nigeria know of the extensive use of Dipyrone in everyday mild to moderate pain including the control of pyrexia in malaria. Dipyrone use in Nigeria is usually in the form of Novalgin IM injection. However it is known that Dipyrone use for mild analgesia is banned in most countries of the world and incidences of fatal anaphylactic shock with its use is recorded in literature.
Nigeria has woken up to this realization and has banned Dipyrone, (rather belatedly!) http://www.thisdayonline.com/nview.php?id=19122
"On November 24 last year, 14 students of the Federal Government College, Ibusa, Delta State, had injections of dipyrone in their school clinic and two of the students developed severe adverse drug reactions, one of them died after having her skin peeled off in large patches on contact. The second student, a 14-year-old suffered severe tissue damage from the upper left buttock to the back knee. The safety profile of all the drugs administered on the patients were reviewed and from all indications, dipyrone injection was responsible for the two cases of the adverse drug reactions"
The Ibusa incidence should have been avoided if regulatory practice in Nigeria was as current as that of numerous other countries. Literature supports that in mild pain management Dipyrone is not superior to other safer analgesics and current use is restricted to acute migraine attack and few other conditions. Extensive availability of Dipyrone in Nigeria was a public health disaster that had to claim this reported Ibusa case (and I bet, numerous other unreported cases!) before it was called to a halt. And this is hoping that the practice will in reality stop!
Any e-drugger who has information on countries where Dipyrone is still licensed and used for mild to moderate pain, or any one with information on ADR involving Dipyrone should please contact me.
regards
Jude Nwokike
Senior Program Associate
RPM Plus
Managements Sciences Heath, MSH.
Windhoek, Namibia.
jnwokike@msh.org.na
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full text of report:
NAFDAC Goes Tough on Novalgin, Analgin Users
By Collins Edomaruse, 06.03.2005
National Agency for Food, Drug Administration and Control (NAFDAC) yesterday asked Nigerians to report any medical practitioner who administers novalgin, analgin or optalgin on them for what it called appropriate action against such medical practitioners.
The drugs were banned early this week by the agency and marketers and users across the country given six months grace within which they were expected to have disposed off the remnants of the product in their possession.
Director-General of the agency, Dr. Dora Akunyili, who made the plea during an exclusive interview with THISDAY, said the action was necessary because of the "serious" dangers the drugs were posing to the health of millions of Nigerians.
She said following tips on the dangers of the drugs from the public and the result of the laboratory test carried out on same by the agency, it became imperative that drastic action had to be taken to stem the negative activities of manufacturers of such killer drugs.
Justifying the agency's action, Akunyili said: "We are aware that many countries, including Canada, Germany, United Kingdom, United States and Sweden, have banned of restricted the use of dipyrone or novalgin ether in combination with the other drugs or as a single substance due to adverse drug reactions.
"In Sweden," she said, the drug was withdrawn in 1074 and re-licensed in 1996 for short term use in acute pain of moderate to severe intensity and restricted to hospital use only.
"Dipyrone and all its brands is restricted to postoperative pain, colic pain, cancer, pain and migraine in Austria, Belgium, France, Italy, The Netherlands, Spain, Switzerland, South Africa, Russia, Israel and India."
Citing an instance of a discovered health threat the banned drugs have posed to users, Akunyili said: "On November 24 last year, 14 students of the Federal Government College, Ibusa, Delta State, had injections of dipyrone in their school clinic and two of the students developed severe adverse drug reactions, one of them died after having her skin peeled off in large patches on contact.
"The second student, a 14-year-old suffered severe tissue damage from the upper left buttock to the back knee.
"The safety profile of all the drugs administered on the patients were reviewed and from all indications, dipyrone injection was responsible for the two cases of the adverse drug reactions," she concluded.