Pam wrote:

This is from the U.S. Food & Drug Administration..........

SAFETY/2005/Dec

CLINICAL PHARMACOLOGY25 The mechanism of action of mesalamine
(and sulfasalazine) is unknown,

PRECAUTIONS  Been implicated in the production of an acute
intolerance syndrome characterized by cramping, acute abdominal
pain and bloody diarrhea, sometimes fever, headache and a rash;
in such cases prompt withdrawal is required.

The patient's history of sulfasalazine intolerance, if any,
should be re-evaluated. If a rechallenge is performed later
in order to validate the hypersensitivity it should be
carried out under close supervision and only if clearly
needed, giving consideration to reduced dosage. In the
literature one patient previously sensitive to sulfasalazine
was rechallenged with 400 mg oral mesalamine; within eight
hours she experienced headache, fever, intensive abdominal
colic, profuse diarrhea and was readmitted as an emergency.
She responded poorly to steroid therapy and two weeks later
a pancolectomy was required.

In a clinical trial most patients who were hypersensitive to
sulfasalazine were able to take mesalamine enemas without
evidence of any allergic reaction. Nevertheless, caution
should be exercised when mesalamine is initially used in
patients known to be allergic to sulfasalazine. These
patients should be instructed to discontinue therapy if
signs of rash or fever become apparent.

Rare instances of pericarditis have been reported with
products containing sulfasalazine. Cases of pericarditis
have also been reported as manifestations of inflammatory
bowel disease.

Chest pain or dyspnea in patients should be investigated
with this information in mind.

Carcinogenesis, Mutagenesis, Impairment of Fertility
The oligospermia and infertility in men associated with
sulfasalazine has very rarely been reported among patients.

There are no adequate and well-controlled studies in
pregnant women for either sulfasalazine or 5-ASA. Because
animal reproduction studies are not always predictive of
human response, 5-ASA should be used during pregnancy only
if clearly needed.

Nursing Mothers
As a general190rule, nursing should not be undertaken
while a patient is on a drug since many drugs are
excreted in human milk.

ADVERSE REACTIONS OCCURRING IN MORE THAN 0.1% OF
TREATED PATIENTS (COMPARISON TO PLACEBO)

SYMPTOM Abdominal Pain/Cramps/Discomfort
Headache  Gas/Flatulence   Nausea   Flu  Fever
Tired/Weak/Malaise/Fatigue   Asthenia   Insomnia
Rash/SpotsCold/Sore Throat   Diarrhea   Dizziness
Leg/Joint Pain   Bloating  Back Pain   Hair Loss
Peripheral Edema      UTI/Urinary Burning    
Rectal Pain/Soreness/Burning

nephrotoxicity, pancreatitis, fibrosing alveolitis and elevated
liver enzymes.

Cases of pancreatitis and fibrosing alveolitis have been reported
as manifestations of inflammatory bowel disease as well.

Published case reports and/or spontaneous post marketing surveillance
have described rare instances of aplastic anemia, agranulocytosis,
thrombocytopenia, eosinophilia, pancytopenia, neutropenia, oligospermia,
and infertility in men.

Anemia, leukocytosis, and thrombocytosis

Hair Loss: Mild hair loss characterized by "more hair in the comb"
In the literature there are at least six additional patients with
mild hair loss who received either mesalamine or sulfasalazine.
Retreatment is not always associated with repeated hair loss.

... Who can I blame for my own problems?
... Give me just a minute...I'll find someone.
___ Blue Wave/QWK v2.12