# E-DRUG: Dipyrone in Sweden **URL:** \ **Category:** e-drug\ **Created:** [October 9, 1997, 11:16pm UTC](https://talk.edrugplus.org/t/e-drug-dipyrone-in-sweden/1506 "1997-10-09T23:16:33Z")\ **Posts on this page:** 1\ **Page:** 1
**Author:** ![myhr](https://avatars.discourse-cdn.com/v4/letter/m/f07891/32.png) [@myhr](https://talk.edrugplus.org/u/myhr)\ **Post date:** [October 9, 1997, 11:16pm UTC](https://talk.edrugplus.org/t/e-drug-dipyrone-in-sweden/1506/1 "1997-10-09T23:16:33Z")
E-DRUG: Dipyrone in Sweden (contd.) ----------------------------------- I will not elaborate on the reasons why dipyrone (also called metamizole) was re-introduced in Sweden. I think enough has been said by others. I will only say that I wish we had kept our need clause because I fear this drug may also appear on the Norwegian market again!. [About the need clause: Since 1928 and until approx. 1992, the requirements for quality, safety, efficacy, cost and need formed the basis for drug evaluation in Norway. A drug could thus be denied registration if the Committee found it of no additional therapeutic value compared to therapeutically equivalent drug already on the market or that it found the number of different generics to be high enough to ensure competition. By including the need clause into the Norwegian drug legislation, a social dimension was introduced into drug policies at a very early stage. Drugs were not only assessed purely from a scientific or technical point of view, but in the light of health priorities and the delivery of health care to the population as a whole. When adopting the EU legislation and regulation, we had to abolish the clause, allowing the market to be flooded with new, expensive drugs of no additional benefit. The 'Obituary' can be found in HAI NEWS No.64, April 1992 page 5. To obtain HAI NEWS please email: ciroap@pc.jaring.my] I am reproducing below excerpts on dipyrone from the information in the Swedish FASS (physicians' desk reference): Dosage forms: tablets and injection Indications: Short-term treatment of acute moderate to serious pain in connection with tissue damage, e.g. surgical procedures, and colic pain, e.g. in urinary or gallbladder tracts. Control of treatment: If symptoms of agranulocytosis or thrombocytopaenia occur, stop treatment immediately and do a blood count (incl. counting of white blood cells). The patient should be told to discontinue treatment if any of the mentioned adverse effects or other unwanted effects occur, and contact a physician. Contraindications: Hypersensitivity to metamizole and other pyrazolone derivatives (e.g. phenazonum) or pyrazolidines. Hepatic porphyria. Congenital G6PD deficiency (risk of haemolysis). Warnings and cautions: Reduced liver- and kidney function. Because of possible cross reaction and hence risk of serious anaphylactic reactions, the drug should not be given to patients with symptoms of asthma, rhinitis, or urticaria when taking ASA (acetyl salicylic acid or aspirin), other NSAIDs (Nonsteroidal anti-inflammatory drugs) or other pain killers (e.g. paracetamol). Metamizole may cause isolated hypotensive reactions which one should be particularly alerted to when treating patients which manifest hypotension, fluid loss, circulatory instability, initial signs of circulatory collapse. Lack of experience in longterm treatment. Interactions: Metamizole may decrease serum levels of cyclosporine. Documentation available indicates that cytochrome P450 is involved in the metabolism of metamizole. Studies to characterize the isoenzymes responsible for the metabolism is lacking, and potential interactions may thus not be predicted. Studies of interactions with warfarin are lacking. Simultaneous intake of alcohol should be avoided. Pregnancy: Metamizole may inhibit contractions in uterus and prolong delivery. It may even cause pulmonary hypertension and neonatal respiratory insufficiency through contraction or closure of ductus arteriosus intrauterinally. Thrombocytic function in the foetus may be inhibited. Effects described in the foetus is thought to be caused by inhibition of prostaglandin synthesis. During last trimester, treatment with antiflogistics which inhibit prostaglandin synthesis should only be prescribed after careful consideration. During the period immediately before delivery, such drugs should not be used. Breast milk: Metamizole is found in such concentration in breast milk that even therapeutic doses may influence the baby. 48 hours after last dose, no metabolites can be detected in the breast milk. Adverse effects: 1/100-1/1000: Hypotensive reactions less than 1/1000: Anaphylactic/anaphylactoid reactions. Leucopaenia, agranulocytosis (1:1 mill), thrombocytopaenia, maculopapular rash, acute kidney failure, sometimes with anuria and oliguria, interstitial nephritis. Pain and local reactions, e.g. thrombophlebitis, at injection site may occur. Steven Johnson's or Lyell's syndrome has been reported. Mild to serious anaphylactic/anaphylactoid reactions may occur in connection with administration. Usually they occur within 1 hour. Serious hypotensive reactions occur rarely. Preventive measures (stabilisation of circulation) may become necessary to reduce the risk of such reactions. Typical signs of agranulocytosis include inflammatory mucous lesions (e.g. oropharyngeal, anorectal, genital), sore throat and fever. Symptoms may be less prominent in patients taking antibiotics simultaneously. Regards Ms Kirsten Myhr, MScPharm, MPH Bygdoy Alle 58B 0265 Oslo Norway Tel: +47 22 56 05 85 (h) Fax: +47 22 24 90 17 (w) Tel: +47 22 24 90 04 (w) E-mail: myhr@online.no or (w): kirsten.myhr@helsetilsynet.dep.telemax.no -- Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'. Mail administrative requests to `majordomo@usa.healthnet.org'. For additional assistance, send mail to: `owner-e-drug@usa.healthnet.org'.