TROVAFLOXACIN MESYLATE
CP-99219-27
Scientific and common names, and synonyms
C.A.S. number 147059-72-1

Legislative or regulation action

USA The Food and Drug Administration has restricted the indications for products containing trovafloxacin or alatrofloxacin to patients having nosocomial infections or complicated intra-
abdominal infections that are serious or life- threatening. This is due to concerns over the risks of serious liver toxicity.
(Reference: (FDATP) Food and Drug Administration Talk Paper, T99-26, , June 1999)

SGP The National Pharmaceutical Administration in the Ministry of Health has not approved trovafloxacin since it is associated with hepatic adverse reactions.
(Reference: (SGPCW) Communication to WHO, , , 02 Aug 2000)

PHL Jan 2000 The Department of Health Bureau of Food and Drugs have banned and withdrawn trovafloxacin since it is associated with hepatic adverse reactions.
(Reference: (PHADO) Administrative Order, (1) s. 2000, , 03 Jan 2000)

VTN Jul 1999 The Drug Administration of Viet Nam in the Ministry of Health has not approved the registration of trovafloxacin (Trovan) solution for injection 5 mg/ml and tablet 200 mg on the basis that these products have a potential for hepatotoxicity.
(Reference: (VTNMHD) Directive, 2785, QLD, 15 July 1999)

MAR Jun 1999 The National Advisory Commission for Pharmacovigilance has decided to restrict the use of trovafloxacin and alatrofloxacin only to university hospitals under professional control and after a total examination of hepatic function. In the meantime, the Commission has launched a survey among prescribers in order to evaluate the risk/benefit balance of this product.
(Reference: (MARDMP) Letter to WHO, , , 24 Aug 1999)

ESP Jun 1999 The Spanish Medicines Agency has suspended the use of medicinal products contain the fluoroquinolone antibiotic, trovafloxacin and the intravenous formulation of the drug,
alatrofloxacin
(Reference: (ESPAES) Communication, , , 15 June 1999)

EME May 1999 The European Agency for the Evaluation of Medicinal Products (EMEA) has recommended that marketing authorization for products containing trovafloxacin or alatrofloxacin be suspended. This follows reports of serious adverse hepatic events.
(Reference: (EMEAPS) Public statement, No.17438/99, , May 1999)

SYR 1999 The Suprim Technical Committee and the Ministry of Health has withdrawn the licensing approval for trovafloxacin and cancelled it from the national essential drug list.
(Reference: (SYRAFD) Announcement from the Directorate, 4/2/1989, , 02 Sep 1999)
 

Sparfloxacin
Scientific and common names, and synonyms
5-AMINO-1-CYCLOPROPYL-7-(CIS-3,5-DIMETHYLPIPERAZIN-1-YL)-6,8-DIFLUORO-4-OXOQUINOLINE-3-CARBOXYLIC
ACID
C.A.S. number 110871-86-8
 

Legislative or regulation action

FRA Jun 1995 The Medicines Agency has announced that in view of a large number of reports of phototoxicity associated with the use of sparfloxacin, the indications for the use of sparfloxacin have been restricted to: acute bacterial pneumonia, diagnostically confirmed by X-ray, and to acute bacterial sinusitis with documented evidence of pneumococcus with reduced sensitivity to penicillin.
(Reference: (FRAAMC) Communiqué de Presse, , , 06 June 1995)


JPN 1995 The Pharmaceutical Affairs Bureau has decided to include a warning statement in the data sheet for sparfloxacin about photosensitivity and rash related to exposure to sunlight.
(Reference: (JPNARD) Information on Adverse Reactions to Drugs, No.127, , July 1994)
 

Temafloxacin
Scientific and common names, and synonyms
QUINOLINECARBOXYLIC ACID (+/-)-(2,4-DIFLUOROPHENYL)-6-FLUORO-1,4-DIHYDRO-7-(3-METHYL-1-PIPERAZINYL)-4-OXO-3-
C.A.S. number 108319-06-8

Legislative or regulation action

WHO Comment : Temafloxacin, a quinolone antimicrobial, was introduced in 1991. Shortly afterwards, its use became associated with severe adverse effects, including hypoglycaemia, haemolytic anaemia, renal failure, hepatitis and anaphylactic reactions. This led to its worldwide withdrawal by the manufacturer.

OMN 22 Jun 1992 Products containing temafloxacin will not be allowed for import and marketing. (Reference: (OMNCR) Circular, 25/92, , June 1992)

WD Jun 1992 Products containing temafloxacin were withdrawn worldwide by the manufacturer, having regard to severe adverse reactions associated with their use, some of which were fatal. Reference: (HHSNS) HHS News: US Department of Health and Human Services, P92-16, ,05 June 1992)

 

C.A.S. number 161967-81-3
Grepafloxacin hydrochloride P

Legislative or regulation action

SGP Grepafloxacin has been voluntarily withdrawn due to an effect of the drug on cardiac repolarization, manifested as QT interval prolongation. Some patients may be at risk of the very rare but serious ventricular arrhythmia known as torsades de pointes.
(Reference: (SGPCW) Communication to WHO, , , 02 Aug 2000)


ARM Jul 2000 Grepafloxacin has been voluntarily withdrawn after the observation of severe cardiovascular events among patients.
(Reference: (ARMCW) Communication to WHO, , , 09 Aug 2000)

PER Dec 1999 La Direcciòn General de Medicamentos, Insumos y Drogas (DIGEMID) of the Ministry of Health has communicated to health professionals that Glaxo Wellcome has voluntarily
withdrawn the fluoroquinolone grepafloxacin from the market because of prolongation of the QT interval giving rise to ventricular arrhythmias known as torsades de pointes.
(Reference: (PERDGM) Alerta DIGEMID, No. 12-99, , 15 Dec 1999)

LTH Nov 1999 Marketing authorization for grepafloxacin was suspended by the State Medicines Control Agency.
(Reference: (LTHMCA) Order of State Medicines Control Agency, No. 96, , 15 Nov 1999)

GBR Oct 1999 Grepafloxacin (Raxar) was voluntarily withdrawn from the market by the licence holder from the market because of a small number of severe cardiac arrhythmias among patients in post-
marketing surveillance.
(Reference: (GBRMCA) Communication to WHO, , , 30 Aug 2000)