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

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