Asclera Side Effects

6 ADVERSE REACTIONS The most common adverse reactions occurring at least 3% more frequently than on placebo are mild local reactions at the site of injection.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Methapharm at 1-866-701-4636 or medinfo@methapharm.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1 Clinical Study 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.

In 5 controlled randomized clinical trials, Asclera has been administered to 401 patients with small or very small varicose veins (reticular and spider veins) and compared with another sclerosing agent and with placebo.

Patients were 18 to 70 years old.

The patient population was predominately female and consisted of Caucasian and Asian patients.

Table 1 shows adverse events more common with Asclera or sodium tetradecyl sulfate (STS) 1% than with placebo by at least 3% in the placebo-controlled EASI study [see Clinical Studies (14) ] .

All of these were injection site reactions and most were mild.

Table 1: Adverse Reactions in EASI-study ASCLERA (180 patients) STS 1% (105 patients) Placebo (53 patients) Injection site haematoma 42% 65% 19% Injection site irritation 41% 73% 30% Injection site discoloration 38% 74% 4% Injection site pain 24% 31% 9% Injection site pruritus 19% 27% 4% Injection site warmth 16% 21% 6% Neovascularisation 8% 20% 4% Injection site thrombosis 6% 1% 0% Ultrasound examinations at one week (±3 days) and 12 weeks (±2 weeks) after treatment did not reveal deep vein thrombosis in any treatment group.

6.2 Post-marketing Safety Experience The following adverse reactions have been reported during use of polidocanol in world-wide experience.