DESCRIPTION

FLEXOST is indicated for the treatment and prevention of osteoarthritis. Its composition is formulated from natural products Glucosamine sulfate 220mg, chondroitin 220mg.

ADVERSE REACTIONS

Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. When taken as recommended in the placebo-controlled clinical trials, the following adverse events were reported (see Table 6) for FLEXOST for use as needed:

Side effects may include Dyspepsia, drowsiness, insomnia, headache. There are rare reports of abdominal pain, loss of appetite, vomiting, and nausea.

Common symptoms with placebo, glucosamine and NSAID

Nonspecific symptoms are commonly reported in clinical trials. In a 3-year study, 93% of subjects receiving placebo reported symptoms (Reginster et al., 2001). The most common symptoms  reported with placebo or glucosamine were: mild gastrointestinal symptoms including constipation, diarrhea, nausea, dyspepsia, excessive gas, abdominal distension, and abdominal cramps; headache; and skin rash or pruritis. Eighteen chronic studies that provided side effect data comparing glucosamine to placebo were analyzed (Table 3). The contents of the placebo capsules used in these studies were: not stated, in 9 studies; lactose, in 3; excipients, in 3; inert material, in 1; calcium carbonate, in 1; and 50% maltodextrin and 50% whey protein, in 1. These studies included 988 subjects followed for a weighted average of 37 weeks. In 13 of the 18 studies, symptoms were reported less commonly in glucosamine-treated subjects than in placebo-treated subjects. The ratio of symptoms for glucosamine compared to those for placebo is presented for each study. The placebo has a score of 1.0 and the frequency of symptoms with glucosamine is a fraction of this. When the frequency of symptoms is the same the ratio for glucosamine is 1.0. When less symptoms are reported for glucosamine than placebo, the ratio is less than 1.0. Only two studies reported that symptoms were more common with glucosamine than placebo.

The frequency of symptoms with glucosamine ranged from none (0.0) to 143% (1.43) of those reported for placebo. The average for the ratio of symptoms for glucosamine compared to placebo was 0.76 (95% confidence interval, 0.61–0.92). This suggests that symptoms were 24% less common with glucosamine than placebo and that this was statistically significant. Richy et al. (2003), in their meta-analysis, indicated that the adverse effect rate with glucosamine was 20% lower than placebo. The Institute of Medicine Report (2004) summarizes case reports and other adverse events occurring with glucosamine use. This report concludes that: ‘‘Human studies show an equal incidence of mild, transient adverse effects in placebo control groups and glucosamine groups.’’ (p. 4, 2004) Five studies compared side effects of glucosamine with ibuprofen, the most commonly used non-steroidal anti-inflammatory drug (NSAID) for arthritis. The prevalence of side effects in patients using glucosamine was 10.0% compared to 32.5% for patients using ibuprofen. The Institute of Medicine (2004) report also concluded that side effects were less common with glucosamine than with ibuprofen.