# E-DRUG: NON -E DRUGS: Barbiturates regulated in Germany **URL:** https://talk.edrugplus.org/t/e-drug-non-e-drugs-barbiturates-regulated-in-germany/50 **Category:** e-drug **Created:** [November 17, 1995, 11:53am UTC](https://talk.edrugplus.org/t/e-drug-non-e-drugs-barbiturates-regulated-in-germany/50 "1995-11-17T11:53:25Z") **Posts on this page:** 1 **Page:** 1
### Author: ![BUKOPharmaKampag](https://avatars.discourse-cdn.com/v4/letter/b/43a26b/32.png) [@BUKOPharmaKampag](https://talk.edrugplus.org/u/BUKOPharmaKampag) #### Post date: [November 17, 1995, 11:53am UTC](https://talk.edrugplus.org/t/e-drug-non-e-drugs-barbiturates-regulated-in-germany/50/1 "1995-11-17T11:53:25Z")
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the study "Barbiturate combinations - Risk without benefit"(i) showing that these drugs are dangerous and should be withdrawn from the world market.Barbiturates are old drugs which have been used as tranquillisers and in sleep disturbances.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Institute for Drugs and Medical Products] has now confirmed to BUKO that all barbiturate combinations have been withdrawn from the German market.(ii) The authority had started the legal "procedure to avoid drug risks" (Stufenplan) and eradicated the barbiturate problem in a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