PATIENT INFORMATION

BEXTRA can cause GI discomfort and, rarely, more serious GI side effects, which may result in hospitalization and even fatal out-comes. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for the signs and symptoms of ulcerations and bleeding, and should ask for medical advice when observing any indicative sign or symptoms. Patients should be apprised of the importance of this follow-up (see WARNINGS—Gastrointestinal (GI) Effects—Risk of GI Ulceration, Bleeding, and Perforation).

Patients should report to their physicians, signs or symptoms of gastrointestinal ulceration or bleeding, skin rash, weight gain, or edema.

Patients should be informed of the warning signs and symptoms of hepatotoxicity (e.g.,nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and flu-like symptoms).If these occur, patients should be instructed to stop therapy and seek immediate medical attention.

Patients should also be instructed to seek immediate emergency help in the case of an anaphylactoid reaction (see WARNINGS—Anaphylactoid Reactions).

In late pregnancy, BEXTRA should be avoided because it may cause premature closure of the ductus arteriosus.

Laboratory Tests

Because serious GI tract ulcerations and bleeding can occur without warning symptoms, physicians should monitor for signs and symptoms of GI bleeding.