ARTHROTEC(R)

SECTION 2: Hazards identification

Appearance: White tablet

Signal word

WARNING

Hazard statements

Causes eye irritation. Causes skin irritation. Harmful if swallowed. May cause damage to: blood and blood forming organs, liver, heart, gastrointestinal system through prolonged or repeated exposure. Suspected of damaging the unborn child. May cause allergic reaction in aspirin-sensitive individuals

Additional information

Short Term: May cause eye irritation, May cause skin irritation. (based on components) . Long Term: Repeat-dose studies in animals have shown a potential to cause adverse effects on blood, spleen, reproductive system, gastrointestinal system. Animal studies indicate that this material may cause adverse effects on the the developing fetus. Known Clinical Effects: Clinical use has caused effects on the gastrointestinal system, including abdominal pain, nausea, vomiting, diarrhea, constipation, peptic ulcer, acid reflux, and gastrointestinal bleeding. Clinical use has resulted in liver effects. Symptoms may include jaundice, liver function test abnormalities, and hepatitis. Clinical use has caused effects on the nervous system, including drowsiness, anxiety, dizziness, visual disturbances. Serious allergic reactions, including anaphylaxis, have been reported. Clinical use of this drug has caused decreased red blood cell count (anemia), effects on blood forming organs. Drugs of this class may cause menstrual irregularities, cramps, pain, postmenopausal menstrual bleeding, miscarriage, uterine rupture, bleeding and death. Miscarriages have been seen in pregnant women taking this drug. Clinical use has caused effects on the cardiovascular system, including heart attack (myocardial infarction), stroke. EU Indication of danger: Harmful Toxic to Reproduction: Category 2 EU Hazard Symbols: EU Risk Phrases: R22 - Harmful if swallowed. R61 - May cause harm to the unborn child. Note: This document has been prepared in accordance with standards for workplace safety, which require the inclusion of all known hazards of the active substance or its intermediates regardless of the potential risk. The precautionary statements and warnings included may not apply in all cases. Your needs may vary depending upon the potential for exposure in your workplace.