BUKO Pharma-Kampagne
August-Bebel-Str. 62, D-33602 Bielefeld, Germany
Telefax +49-521-63789, Phone +49-521-60550, e-mail 100270,272@compuserve.com
Dear collegues,
this is an information on non-essential drugs which may be useful for you. The
information on the regulatory decisions on barbiturates in Germany has not been
published and surfaced only after "squeezing" it out of the German authorities.
Please react whether this is useful information for e-drug users - or rather
not.
Best wishes Joerg Schaaber
Barbiturates use strictly limited in Germany
Two years ago BUKO Pharma-Kampagne and HAI have published the study "Barbiturate
combinations - Risk without benefit"(i) showing that these drugs are dangerous
and should be withdrawn from the world market.Barbiturates are old drugs which
have been used as tranquillisers and in sleep disturbances. Barbiturates have
been combined with many other active substances and were used for a lot of
indications e.g. as painkillers, anti-astmathics, gastrointestinal drugs,
anti-hypertensives. For all those indications the use of barbiturates nowadays
seen as irrational and dangerous because of the high potential for abuse and
addiction and the toxicity of the drug.
All concerned registration authorities got a copy of Barbiturate Combinations -
Risks without benefit and were asked to become active. HAI/BUKO got encouraging
reactions on the publication - mainly from prescribers or other people
interested in health matters. But silence does not always mean that nothing
happens. BUKO found out that the German health authorities have become active in
the meantime. The Bundesinstitut fuer Arzneimittel und Medizinprodukte (BfArM)
[Federal Institute for Drugs and Medical Products] has now confirmed to BUKO
that all barbiturate combinations have been withdrawn from the German
market.(ii) The authority had started the legal "procedure to avoid drug risks"
(Stufenplan) and eradicated the barbiturate problem in a straight way: All
substances except two (hexobarbital and phenobarbital) and all indications
except epilepsy and pre-medication in anaesthesia have been banned. All but two
manufacturers did react to the authorities move.(iii) One of them has been
alerted by a phone-call by BUKO and promptly confirmed by fax that he accepts
the limitation of indications and even more important that he will not export
the drug because he agrees that this would be a breach of the German export
control law for drugs.(iv) The other one still kept silent. We have got now the
confirmation from the authorities that the second manufacturer has agreed to
stop the production of barbiturates altogehter.(v)
i available from HAI, Jacob van Lennepkade 334T, NL-1053 NJ Amsterdam, The
Netherlands, e-mail hai@hai.antenna.nl
German version from BUKO Pharma-Kampagne (free for people from developing
countries)
ii Letter of the Bundesinstitut fuer Arzneimittel und Medizinprodukte
(BfArM) to BUKO Pharma-Kampagne dated 12.April 1995
iii Both did sell only the still allowed mono-substance products but had to
confirm that they accept the limitation of indications.
iv Letter from E. Denk to BUKO Pharma-Kampagne dated 28.April 1995
v Letter from the Ministerium fuer Arbeit, Soziales und Gesundheit
Rheinland Pfalz dated 9. November 1995