ARTHROTEC Safety Information
CONTRAINDICATIONS AND WARNINGS
ARTHROTEC® CONTAINS DICLOFENAC SODIUM AND MISOPROSTOL. ADMINISTRATION
OF MISOPROSTOL TO WOMEN WHO ARE PREGNANT CAN CAUSE ABORTION, PREMATURE BIRTH, OR
BIRTH DEFECTS. UTERINE RUPTURE HAS BEEN REPORTED WHEN MISOPROSTOL WAS ADMINISTERED
IN PREGNANT WOMEN TO INDUCE LABOR OR TO INDUCE ABORTION BEYOND THE EIGHTH WEEK OF
PREGNANCY (see also PRECAUTIONS). ARTHROTEC SHOULD NOT BE TAKEN BY PREGNANT
WOMEN (see CONTRAINDICATIONS, WARNINGS and PRECAUTIONS).
PATIENTS MUST BE ADVISED OF THE ABORTIFACIENT PROPERTY AND WARNED NOT TO GIVE THE
DRUG TO OTHERS. ARTHROTEC should not be used in women of childbearing potential
unless the patient requires nonsteroidal anti-inflammatory drug (NSAID) therapy
and is at high risk of developing gastric or duodenal ulceration or for developing
complications from gastric or duodenal ulcers associated with the use of the NSAID
(see WARNINGS). In such patients, ARTHROTEC may be prescribed if the patient:
- has had a negative serum pregnancy test within 2 weeks prior to beginning therapy.
- is capable of complying with effective contraceptive measures.
- has received both oral and written warnings of the hazards of misoprostol, the risk
of possible contraception failure, and the danger to other women of childbearing
potential should the drug be taken by mistake.
- will begin ARTHROTEC only on the second or third day of the next normal menstrual
period.
Cardiovascular Risk
- NSAIDs may cause an increased risk of serious cardiovascular thrombotic events,
myocardial infarction, and stroke, which can be fatal. This risk may increase with
duration of use. Patients with cardiovascular disease or risk factors for cardiovascular
disease may be at greater risk (see WARNINGS).
- ARTHROTEC is contraindicated for treatment of peri-operative pain in the setting
of coronary artery bypass graft (CABG) surgery (see WARNINGS).
Gastrointestinal Risk
- NSAIDs cause an increased risk of serious gastrointestinal adverse events including
bleeding, ulceration, and perforation of the stomach or intestines, which can be
fatal. These events can occur at any time during use and without warning symptoms.
Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS).
ARTHROTEC is the only FDA-approved NSAID for the treatment of the signs and symptoms of
osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSIAD-induced
gastric and duodenal ulcers and their complications
Important Safety Information
ARTHROTEC is contraindicated in women who are pregnant or who may become pregnant. ARTHROTEC
can cause miscarriage, often associated with bleeding, which may result in other serious
complications.
Cardiovascular Risk
-
NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial
infarction, and stroke, which can be fatal. This risk may increase with duration of use.
Patients with cardiovascular disease or risk factors for cardiovascular disease may be at
greater risk.
-
ARTHROTEC is contraindicated for treatment of peri-operative pain in the setting of
coronary artery bypass graft (CABG) surgery.
Gastrointestinal Risk
-
NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding,
ulceration, and perforation of the stomach or intestines, which can be fatal. These events can
occur at any time during use and without warning symptoms. Elderly patients are at greater risk
for serious gastrointestinal events.
ARTHROTEC is contraindicated in patients with hypersensitivity to diclofenac or to misoprostol or
other prostaglandins and in patients who have experienced asthma, urticaria, or other allergic-type
reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to
diclofenac have been reported.
The most common adverse events in ARTHROTEC-treated patients are abdominal pain (21%), diarrhea (19%),
dyspepsia (14%), nausea (11%), and flatulence (9%).
As with all NSAIDs, ARTHROTEC can lead to worsening of pre-existing hypertension or the onset of new
hypertension, fluid retention, edema, or heart failure. ARTHROTEC should be used with caution in these
patients.
Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury
and may cause a dose dependent reduction in prostaglandin formation. Elevations in ALT and/or AST,
and rare cases of severe hepatic reactions have also been reported. Transaminases should be monitored
within 4-8 weeks after initiating treatment with ARTHROTEC and should be measured periodically
thereafter.
Use the lowest effective dose for the shortest duration consistent with individual patient
treatment goals.
NSAIDs can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson
syndrome, and toxic epidermal necrolysis, which can be fatal.