E-drug: Is Co-artem an essential drug?
-------------------------------------------------------------------------
[With regards to the comments below, I wonder whether Mr Jansen's
confusion is due to the fact that he talks about Co-artem being
artemether + benflumetol and being artemether + lumefantrine. For
all clarity, Coartem is a combination of artemeter and lumefantrine.
HH]
I would like to draw the attention of e-drug readers to a serious
question about essential drugs for malaria. It concerns the Essential
drug for malaria Co-artem: a fixed combiantion of20 mg Artemether
and 120 mg Benflumetol (lumefantrine) in a single tablet, packed as
16 tablets per box. In some European countries the drug is available
under the brand name Riamet and is distributed by Novartis.
Last year the drug combination Co-artem (artemether-benflumetol
20/120 mg fixed combination) was added to the essential drug list. I
read and studied the comments given on this topic at the occasion of
the application (Review of application for inclusion of a drug in the
WHO essential drug list: application for a fixed combination of
artemether and lumefantrine). However, when I am reading the
scientific leaflet issued by the Swiss authorities on Riamet (which is in
fact the same medicament) many questions are left open (see
information on Riamet by "Information medicale du compendium
Suisse des Medicaments; see also comments made by the Medicines
Evaluation Board of The Netherlands)
Most of the questions that are puzzling me are:
- contraindication: children under 12 year (whereas in this age group
of children we see the highest mortality)
- recommendation: not to be used in the elderly
- warning for patients with renal or liver problems
- not to be used in complicated malaria
- warning for patients with a family history of prolonged QTc.
- not to be used for complicated malaria
- not to be used in cerebral malaria
- not recommended in pregnant women
- should only be given together with food, otherwise extremely low
absorption of lumefantrine (<10%)
- the dose of artemether is very low: 320 mg in total.
- the package presented contains only 16 tablets but the
recommendation given for areas of resistant malaria is 24 tablets.
- A presentation for children does not exist. (but children are at the
greatest risk and represent more than 70% of the death rate in Africa)
In fact a long list of mainly severe restrictions. This makes this drug
almost totally unacceptable for broad use in an African setting.
In addition the drug Co-artem is offered at so called cost price of 2.40
US Dollar per pack when purchased through WHO (information from
several African malaria boards), which is a very high price for Africa
and this figure does not reflect the real cost price (where is the profit
going ?).
It is therefore astonishing to see that Co-artem was accepted as
essential drug (and replaces artemether and artesunate which are
pushed back to the status of reserve drug) and that this is maintained
so over the year(s) to come. At least this year no recommendation of
change is being made.
Either the Swiss and Dutch authorities are wrong in their comments
on Co-artem or something is wrong at the decision level at the
committee for Essential drugs.
A clarification is urgently needed.
Sincerely yours,
Dr. F.H. Jansen
Internal Medicine
30 Witte Bremlaan
2360 Oud-Turnhout
Belgium
Fhjansen@skynet.be
--
To send a message to E-Drug, write to: e-drug@usa.healthnet.org
To subscribe or unsubscribe, write to: majordomo@usa.healthnet.org
in the body of the message type: subscribe e-drug OR unsubscribe e-drug
To contact a person, send a message to: e-drug-help@usa.healthnet.org
Information and archives: http://www.essentialdrugs.org/edrug