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Resolution
- RE nš 356, 28 February 2002
(DO dated 03/04/02)
As the Chairman of the Collegiate Directorate of the Brazilian
Sanitary Surveillance Agency, in the use of the attributions vested
in it by Administrative Order nº 724 of the Chairman-Chairman,
dated 10 October 2000;
WHEREAS § 3, of article 111 of the Internal Regulation approved
by Administrative Order nº 593, dated 25 August 2000, republished
on 22 December 2000;
WHEREAS Art. 6, of Law nº 6.360, dated 23 September 1976;
WHEREAS Art. 7, of Decree nº 79.094, dated 5 January 1977;
WHEREAS the
Brazilian population in general considers medicinal plant-based
products to be innocuous, posing no risks to health;
WHEREAS products based on Kava-Kava (Piper methysticum L.) are
pharmacologically active and sold in pharmaceutical forms to treat
anxiety and tension;
WHEREAS hepatoxicity is not uncommon with plant-based products;
WHEREAS recent reports of serious cases of hepatitis, liver insufficiency
and liver cirrhosis in 25 patients of Germany and Switzerland
that used products containing Kava-Kava (Piper methysticum L.),
notified through the pharmacovigilance system of those countries;
WHEREAS Brazilian consumers that have some degree of liver damage
or even damage related to alcohol use can be acquiring products
based on Kava-Kava (Piper methysticum L.) without a proper medical
evaluation by acquiring products that do not have the red strip
with the warning “Prescription Only”, thus increasing
the risk of serious adverse reactions to the liver resulting in
the possible need of a liver transplant or even in death;
WHEREAS Kava-Kava (Piper methysticum L.) products are widely sold
in the national territory and are possibly being consumed in an
irrational and indiscriminate manner; I hereby resolve to:
Art. 1. Determine as a measure of sanitary interest the seizure
in the national territory of any pharmaceutical product containing
Kava-Kava (Piper methysticum L.) that does not have a red strip
with the warning “Prescription Only”.
Art. 2. Seize, all throughout the national territory, any pharmaceutical
product containing Kava-Kava (Piper methysticum L.) that is not
registered in this Agency.Art. 3. This Resolution enters into
force on the date of its publication.
GONZALO
VECINA NETO
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