Limbrel

SIDE EFFECTS

In a randomized, double-blind placebo-controlled safety study of 60 days, subjects ingested either 125 mg of LIMBREL (flavocoxid) or placebo. Rates of symptomatic adverse events were low and did not differ between the LIMBREL (flavocoxid) and placebo arms. There were also no usage-related changes in routine hematological or biochemical safety parameters.

In a controlled clinical trial of 90 days duration, the incidence of clinical side effects and changes in routine hematological and biochemical parameters and incidence of fecal occult blood positivity were identical for the LIMBREL (flavocoxid) and placebo groups. Adverse events reported included increased varicose veins, elevated hypertension, fluid accumulation in the knee, psoriasis in the LIMBREL (flavocoxid) 125 mg BID arm, psoriasis in the LIMBREL (flavocoxid) 250 mg BID arm, and reduced flexibility in the placebo arm.

Adverse reactions were also collected in a double-blind, randomized clinical trial of 30 days, although this study was not designed to specifically assess usage-related differences in adverse events. Overall, no serious adverse events were reported for LIMBREL (flavocoxid) . There was a non-significant trend toward more frequent edema and nonspecific musculoskeletal events in the naproxen arm. No significant changes were observed within or between arms for weight, systolic blood pressure, or diastolic blood pressure. As expected in a trial of this duration, no fecal occult blood was detected in study subjects, including those taking naproxen.

Special Studies

Gastrointestinal

In a retrospective study, 8 healthy adult subjects, ranging in age from 41 to 60 years, ingested LIMBREL (flavocoxid) daily for periods ranging from 5 to 11 months (mean 7 months). Daily amount ranged from 300 mg to 1,500 mg (mean of 825 mg). Six subjects were male and 2 were female. No subjects reported a prior history of gastrointestinal ulceration. Analysis for fecal occult blood was conducted on three consecutive days. No subjects in this trial were positive for fecal occult blood.

In a second retrospective study, 13 healthy adult subjects ranging in age from 38 to 58 ingested LIMBREL (flavocoxid) daily for periods ranging from 5 to 15 months (mean of 8 months). Daily administration ranged from 150 mg to 600 mg (mean of 375 mg). Seven subjects were male and 6 subjects were female. No subjects reported a prior history of gastrointestinal illness. Analysis for fecal occult blood was conducted on three consecutive days. No subjects in this trial were positive for fecal occult blood. One subject had an event of occult bleeding prior to the measurement date, withdrew from the product, and was unavailable for retrospective analysis. This subject was found to have an unreported prior history of gastrointestinal ulceration. The most commonly reported LIMBREL (flavocoxid) adverse event in all clinical trials is diarrhea and flatulence occuring in 5-8% of subjects. No subject has discontinued participation in a trial because of these symptoms.

Endoscopic examinations have not been conducted in LIMBREL (flavocoxid) users.

Special Populations

Patients Anticoagulated with Warfarin

LIMBREL (flavocoxid) was administered to 59 patients who were taking warfarin chronically. Prothrombin times measured 2 weeks after the addition of LIMBREL (flavocoxid) were unchanged in the majority of patients. In 2 patients the prothrombin time was lengthened and in 2 patients was shortened beyond 2 standard deviations. It is not known whether these represented variation in laboratory testing or reflect a CYP450 polymorphism affecting warfarin metabolism. Because of this, physicians are advised to check prothrombin time one to two weeks after initiating LIMBREL (flavocoxid) in patients anticoagulated with warfarin.

Clinical studies have not been performed to assess the safety and efficacy of LIMBREL (flavocoxid) in pediatric, geriatric, hepatic insufficiency, renal insufficiency, and immunologically compromised patient populations.

Post-Marketing Surveillance

In post marketing surveillance of over 60,000 patients and 100,000 prescriptions of LIMBREL (flavocoxid) , a total of 53 cases of side effects were reported. The most serious side effects were 4 cases of edema, 1 case of upper gastrointestinal bleeding, and 3 cases of elevation of liver tests (ALT, AST and Alkaline phosphatase) all of which resolved without residual effects after discontinuing LIMBREL (flavocoxid) . Notably, no serious or acute cardiovascular events have been reported. One case of first trimester miscarriage has been reported in a patient taking 7 prescription drugs concomitantly (including 2 drugs with warnings against use during pregnancy). The relevance of this case to LIMBREL (flavocoxid) is unknown. No other serious events have been reported.

Read the Limbrel (flavocoxid) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Please refer to CLINICAL PHARMACOLOGY: Drug Interactions.

Last reviewed on RxList: 7/24/2008
This monograph has been modified to include the generic and brand name in many instances.

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