Within
the drug monographs as well as the literature we find NUMEROUS
citations in which fluoroquinolone vasculitis is cited:
UTIN-400
From the South African Electronin Package Inserts
UTIN-400
(Tablets)
COMPOSITION
Each coated tablet contains 400 mg Norfloxacin
Side-effects: The most common side effects reported are
gastro-intestinal effects (abdominal or stomach pain, nausea,
anorexia, vomiting, diarrhoea and heartburn), central nervous system
toxicity (dizziness, headache, nervousness, drowsiness, insomnia).
Others which are less common include central nervous stimulation
(psychosis, depression, convulsions, agitation, confusion,
hallucinations, visual disturbances and tremors), hypersensitivity
reactions (skin rash, photosensitivity, itching or redness,
Stevens-Johnson syndrome, shortness of breath, swelling of face or
neck, vasculitis), interstitial nephritis
(bloody or cloudy urine, fever, rash, swelling of feet or lower legs).
Very rarely photosensitivity has been reported. Pseudomembranous
colitis has been reported. Peripheral neuropathy has occurred.
October 2001
From the Purdue Research Foundation, regarding fluoroquinolones:
Adverse effects
Allergies
Hypersensitivity can occur rarely
Skin rash, itching, or redness, Stevens-Johnson syndrome, shortness of
breath, swelling of face or neck, vasculitis
For information contact:
Gordon L. Coppoc, D.V.M., Ph.D., Head E-Mail: coppoc@purdue.edu
Copyright Purdue Research Foundation 1996, 1997, 1998, 1999, 2000,
2001, 2002 All rights reserved
Revised: November 3, 2002
Side effects of the quinolones have varied according to the specific
compounds and include central nervous system stimulation,
gastrointestinal disturbances, vasculitis, and
photosensitization. Monitoring for toxicity is incompletely reliable
in identifying all potential serious side effects such as the "temafloxacin
syndrome."
http://www.farmclin.com/farmclin/trova.htm
From the package insert for Factive
Serious and occasionally fatal events, some due to hypersensitivity
and/or some of uncertain etiology, have been reported in patients
receiving fluoroquinolones. These events may be severe and generally
occur following the administration of multiple doses. Clinical
manifestations usually include new onset fever and one or more of the
following: rash or severe dermatologic reactions (e.g., toxic
epidermal necrolysis, Stevens-Johnson Syndrome); vasculitis,
arthralgia, myalgia, serum sickness; allergic pneumonitis,
interstitial nephritis; acute renal insufficiency or failure;
hepatitis, jaundice, acute hepatic necrosis or failure; anemia,
including hemolytic and aplastic; thrombocytopenia, including
thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis;
pancytopenia; and/or other hematologic abnormalities.
Recommended testing:
Antineutrophil cytoplasmic antibodie (ANCA) are useful diagnostic
serological markers for systemic vasculitis - ANCA-associated small
vessel vasculitis (Wegener's granulomatosis, microscopic polyangitis,
Churg-Strauss syndrome and drug induced ANCA associated vasculitis).
With indirect immunofluorescence (IIF), two distinct patterns are
detected: a centrally accenthated cytoplasmic staing (cANCA) and a
perinuclear staing (pANCA). cANCA are autoantybodies to proteinase 3
(PR3-ANCA) and pANCA to myeloperoxidase (MPO-ANCA) neurtophil granules
and monocyte lysosomes. The value of ANCA test for differential
diagnosis of small vessel vasculitis can be increased by combining two
assay methods - the IIF test together with standardized antigen
specific ELISA. The sensivity of ANCA in the diagnosis depends on the
activity of the disease. In Wegener's granuloma cANCA sensivity varies
from 60% to 96%, most patient with microscopic polyangiitis have pANCA
positive. Other diseases without vasculitis were reposted to be
associated with ANCA, for example inflammatory bowel disease -
ulcerative colitis, rheumatoid arthritis or Sjögren syndrome. ANCA
play an active role in the immunopathogenesis of vasculitis. The
pathogenesis includes different immunologic mechanisms that make
leukocytes and monocytes adhere to endothelial cells and release
injurious products - free oxygen radicals and lysosomal proteolytic
enzymes, including ANCA antigen themselves. Inflammation and necrosis
of blood-vessel walls in ANCA-associated vasculitis belong to type II
immune reactions.
Tequin:
In general, fluoroquinolones can cause gastrointestinal side effects,
skin rashes, and central nervous system disturbances (e.g., dizziness,
insomnia, confusion, hallucinations, seizures). Although rare,
tendinitis and hypersensitivity reactions (e.g., vasculitis,
serum-sickness-like reactions, anaphylaxis) can occur.
http://daccx.bsd.uchicago.edu/drug/Bulletins/SEP2002.html
IMMUNOLOGIC
A. Hypersensitivity reactions including anaphylaxis and
vasculitis have been associated with fluoroquinolone use.
http://www.kimsonline.co.kr/drugsearch/micromedex/
POISINDEX%20MANAGEMENTS.asp
From the NDA NDA 19-847/S-026 NDA 19-857/S-028 NDA 19-858/S-022 Bayer
Others:drug fever, chills, serum sickness-like re-action,
anaphylactoid reaction, anaphy-laxis, angioedema, bronchospasm and
vasculitis
www.fda.gov/cder/foi/appletter/2002/19847s26ltr.pdf
