rofecoxib (cont.)
PREGNANCY: The use of rofecoxib in pregnant women has not
been studied. In studies in rats, doses that were 10 or 28 fold
higher than the recommended
human dose were not harmful to fetuses; however, in studies in
rabbits, doses twice the
recommended dose for humans were harmful to the fetuses. Therefore,
rofecoxib should be used in pregnant women only when the potential
benefits outweigh the potential risk to the fetus.
NURSING MOTHERS: The use of rofecoxib in nursing mothers
has not been evaluated.
SIDE EFFECTS: Although stomach and intestinal
ulcers occur
with the use of rofecoxib, they occur less frequently than with other
NSAIDs in
short-term studies. Rofecoxib does not interfere with the function
of the platelets in the blood, and, as a result, it does not
interfere with blood clotting and promote bleeding like other
NSAIDs.
The most common side effects of rofecoxib are headache, abdominal
pain, dyspepsia,
diarrhea, nausea, heartburn and water retention. Other side effects
include insomnia,
urinary retention (inability to urinate), heart failure, aggravation
of hypertension, chest pain, ringing in the ears, stomach and
intestinal ulcers, bleeding, blurred vision, anxiety, weight gain,
flu-like symptoms, drowsiness and weakness.
Allergic type reactions can occur with rofecoxib. Persons
who have developed allergic reactions (rash, itching, difficulty breathing) from aspirin
or other
NSAIDs may experience an allergic reaction to rofecoxib and should
not use rofecoxib.
Vioxx should be used cautiously in patients with heart disease.
Reference: FDA Prescribing Information
Last Editorial Review: 9/30/2004
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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