Date: 9/5/2006 1:54:30 AM Pacific Daylight Time

http://www.akdae.de/en/20/20/762-20060807.html ( translation Google language tools) NOTE: This article has been translated from German to English using the Google Translation Tool.  As such it would contain numerous translation errors.

Fatal hypoglycemia induced by levofloxacin (Tavanic®) (UAW-News - International)

Fluoroquinolones (gyrase inhibitors) are efficient antibacterial substances on the one hand but cause a lot of different partially serious adverse drug reactions (ADR). In the past some fluoroquinolones had to be withdrawn from the market because of its serious adverse effects. There are only few reports of hypoglycemia’s known to the DCGMA but nearly all of them were caused by fluoroquinolones.

German physician sheet, volume. 103, issue 31-32, 07.08.2006 Fluoroquinolones (Gyrasehemmer) are well effective antibacterial substances with a however very broad spectrum to partial substantial unwanted medicament effects (UAW). Some representatives of this group of active substances had to be taken in the past because of heavy side effects again by the market. Hypoglycemia was reported rarely, but practically after all Fluoroquinolones. Typically they arise in the first three days after beginning of therapy. Older patients with Typ-2-Diabetes and particularly those, who take sulphonyl urea, seem to be particularly endangered. On a 79-jährigen multimorbiden patient (185 cm/105 kg) with a Typ-2-Diabetes is reported (1). In addition he suffered from a koronaren heart illness, hypertonia, charge and a geringergradigen kidney insufficiency after loss of a kidney. During a stationary treatment the patient developed fever. An aspiration pneumonia was assumed and given Levofloxacin (250 mg i.v.). The patient was increasingly somnolent. Six hours after the injection a blood sugar was determined of 6,0 mg/dl. The patient received Dextrose, Levofloxacin was set off. The condition of the patient worsened continuously, it attained consciousness not again. Finally the life-supporting measures were stopped, and the patient deceased. The authors do not assume the other medicines, which the multimorbide patient received, when trips come for this fatal Hypoglycemia infrage. Fluoroquinolones are frequently ordered medicaments. They were ordered for 2004 with 28,4 millions DDD (2), with altogether far rising tendency (+ 12.9 per cent). Of it among other things Moxifloxacin 5.9 millions, Levofloxacin 4.8 millions and Ofloxacin 3.2 millions DDD were allotted to Ciprofloxacin 10.5 million. In the German spontaneous signaling system (common database of BfArM and AkdÄ, conditions: 12.07.2006) is seized 847 cases of suspicion of unwanted medicament effects in connection with Levofloxacin. In the foreground stand with two thirds of all messages UAW at the muscle and skeleton system. Also, disturbances of the Gastrointestinaltraktes (30 per cent), generalized illnesses of the nervous system (34 per cent) disturbances (30 per cent) and skin reactions (29 per cent) are frequently called. A Hypoglycemia is specified only in two cases. For the entire group of the Fluoroquinolones17 cases of a Hypoglycemia as well as a case of a hypoglykämischen coma are with altogether 5256 messages. The AkdÄ had already referred in connection with the Gatifloxacin taken in the meantime by the market to possible Hypoglycemia (3). In the specialized information from Tavanic® (4) Hypoglycemia, in particular with Diabetikern, are specified as very rare UAW. Since it concerns an easily recognizable and easily treatable UAW, which can run however - as recognized in the available case not in time - deadly, is to be reminded here of the potential risk. Please you communicate the AkdÄ all observed side effects (also cases of suspicion). They can use for it the report elbow printed in regular intervals in the German physician sheet on the next to last cover page or call this up from the AkdÄ Internetpräsenz www.akdae.de.

Literature

1. Friedrich LV, Dougherty R: Fatal hypoglycemia associated with levofloxacin. Pharmacotherapy 2004; 24:1807 - 12.

2. Schwabe U, Paffrath P (Hrsg.): Medicine regulation report 2005. Springer medicine publishing house Heidelberg 2006.

3. Medicament commission of the German medical profession: From the UAW data base: Hypoglycemia under Gatifloxacin. Dtsch Arztebl 2004; 101: A 366.

4. Specialized information Tavanic® 250 mg/500 mg film tablets, October 2004.

Medicament commission of the German medical profession Managing director Professor Dr. med. H. Berthold Herbert Lewin place 1 10623 Berlin P.o. box 12 08 64 10598 Berlin Tel.: +49 30 400456-500 Fax: +49 30 400456-555 E-Mail: info@akdae.de