Xenical (Orlistat) Adverse Reactions
- abdominal pain
- anaphylactoid reactions
- angioedema
- anxiety
- back pain
- bronchospasm
- bullous rash
- depression
- diarrhea
- dizziness
- edema
- elevated hepatic enzymes
- fatigue
- fecal incontinence
- fecal urgency
- flatulence
- headache
- hepatitis
- hypoglycemia
- hypovitaminosis
- increased defecation
- infection
- musculoskeletal pain
- myalgia
- nausea/vomiting
- pruritus
- rash (unspecified)
- steatorrhea
- urticaria
- vaginitis
Xenical (Orlistat) Adverse Reactions
GI symptoms that occurred at least twice that of placebo in >= 5% of patients taking orlistat during double-blind, placebo-controlled clinical trials include flatulence with discharge (23.9% year 1; 4.4% year 2; placebo roughly 1%), fecal urgency (22.1% year 1; 2.8% year 2; placebo 6.7% year 1), fecal incontinence (7.7% year 1; 1.8% year 2; placebo < 1%), steatorrhea (20% year 1; 6% year 2; placebo 2.9% year 1), oily spotting (26.6% year 1; 4.4% year 2; placebo roughly 1%), oily evacuation (12% year 1; 2.3% year 2; placebo < 1%) and increased defecation (10.8% year 1; 2.6% year 2; placebo 4.1% year 1). These and other commonly observed adverse effects were usually mild to moderate with approximately 50% lasting for less than one week. At least 1 GI event occurred in 79% of patients in the orlistat group compared to 59% in the placebo group. During the first year of trials, the dropout rate due to adverse effects, primarily steatorrhea, was significantly higher for orlistat (9.1%) compared to placebo (4.0%) groups. Adverse effects decreased during the second year of study. Overall dropout rates due to adverse effects were similar for both groups over the 2 year period. Adverse gastrointestinal events associated with orlistat may increase with a diet containing greater than 30% of calories from fat. To prevent exacerbation of GI reactions, patients should adhere to the recommended diet plan while taking orlistat. Psyllium has been reported to be an effective fiber adjunct to reduce some of the GI side effects associated with orlistat.
The following adverse events occurred in >= 2% of patients taking orlistat during the first or second year of double-blind, placebo-controlled clinical trials (and at a percentage rate greater than placebo): abdominal pain (25.5 vs. 21.4% placebo); nausea/vomiting (8.1/3.1% vs. 7.3/3.5% placebo); dizziness (5.2 vs. 5% placebo); infectious diarrhea (5.3 vs. 4.4% placebo); rectal pain (5.2 vs. 4% placebo); gingival disorder (4.1 vs. 2.9% placebo); headache (31 vs. 28% placebo); influenza (39.7 vs. 36.2% placebo); general musculoskeletal pain, such as back pain (13.9 vs. 12.1% placebo), arthritis (5.4 vs. 4.8% placebo), and myalgia (4.2 vs. 3.3% placebo); menstrual irregularity (9.8 vs. 7.5% placebo);,fatigue (7.2 vs. 6.4% placebo); pedal edema (2.8 vs. 1.9% placebo); anxiety/depression (2.8/3.4% vs. 2.1/2.5% placebo); rash (unspecified) (4.3 vs. 4% placebo); respiratory tract infection (46 vs. 40% placebo); otitis (4.3 vs. 3.4% placebo); urinary tract infection (5.9 vs. 4.8% placebo); vaginitis (2.6 vs. 1.9% placebo); rectal pain (5.2 vs. 4% placebo). In the 4-year XENDOS study, the general pattern of adverse events was similar to that reported for the 1- and 2-year studies with the total incidence of gastrointestinal-related adverse events occurring in year 1 decreasing each year over the 4-year period.
Low serum levels of beta-carotene and vitamins A, D, and E were observed in a greater percentage of patients receiving orlistat compared to those taking placebo. Actual deficiencies due to hypovitaminosis may be prevented through the use of a daily multivitamin supplement that contains fat-soluble vitamins.
Rare post-marketing cases of hypersensitivity reactions have been reported with the use of orlistat. Signs and symptoms have included pruritus, rash (unspecified), urticaria, angioedema, bronchospasm, and anaphylactoid reactions. Very rare cases of bullous rash or eruption, elevated hepatic enzymes, increased alkaline phosphatase, and exceptional cases of hepatitis that may be serious have been reported. No causal relationship or physiopathological mechanism between hepatitis and orlistat therapy has been established. Reports of decreased prothrombin, increased INR, and unbalanced anticoagulant treatment resulting in change of hemostatic parameters have been reported in patients treated concomitantly with orlistat and anticoagulants. In clinical trials in obese diabetic patients, hypoglycemia and abdominal distension were also observed.
[ Last revised: 9/15/2005 2:16:00 PM ]
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