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Veregen (Sinecatechins Topical) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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 Phase 3 clinical trials, a total of 397 subjects received Veregen® three times per day topical application for the treatment of external genital and perianal warts for up to 16 weeks.

Serious local adverse events of pain and inflammation were reported in two subjects (0.5%), both women.

In clinical trials, the incidence of patients with local adverse events leading to discontinuation or dose interruption (reduction) was 5% (19/397). These included the following events: application site reactions (local pain, erythema, vesicles, skin erosion/ulceration), phimosis, inguinal lymphadenitis, urethral meatal stenosis, dysuria, genital herpes simplex, vulvitis, hypersensitivity, pruritus, pyodermitis, skin ulcer, erosions in the urethral meatus, and superinfection of warts and ulcers.

Local and regional reactions (including adenopathy) occurring at >1% in the treated groups are presented in Table 1.

Table 1: Local and Regional Adverse Reactions During Treatment (% Subjects)
Veregen®
(N = 397)
Vehicle
(N = 207)
Erythema 70 32
Pruritus 69 45
Burning 67 31
Pain/discomfort 56 14
Erosion/Ulceration 49 10
Edema 45 11
Induration 35 11
Rash vesicular 20 6
Regional Lymphadenitis 3 1
Desquamation 5 <1
Discharge 3 <1
Bleeding 2 <1
Reaction 2 0
Scar 1 0
Irritation 1 0
Rash 1 0

A total of 266/397 (67%) of subjects in the Veregen® group had either a moderate or a severe reaction that was considered probably related to the drug, of which 120 (30%) subjects had a severe reaction. Severe reactions occurred in 37% (71/192) of women and in 24% (49/205) of men. The percentage of subjects with at least one severe, related adverse event was 26% (86/328) for subjects with genital warts only, 42% (19/45) in subjects with both genital and perianal warts and 48% (11/23) of subjects with perianal warts only.

Phimosis occurred in 3% of uncircumcised male subjects (5/174) treated with Veregen® and in 1% (1/99) in vehicle.

The maximum mean severity of erythema, erosion, edema, and induration was observed by week 2 of treatment.

Less common local adverse events included urethritis, perianal infection, pigmentation changes, dryness, eczema, hyperesthesia, necrosis, papules, and discoloration. Other less common adverse events included cervical dysplasia, pelvic pain, cutaneous facial rash, and staphylococcemia.

In a dermal sensitization study of Veregen® in healthy volunteers, hypersensitivity (type IV) was observed in 5 out of 209 subjects (2.4%) under occlusive conditions.



REPORTS OF SUSPECTED VEREGEN SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Veregen. The information is not vetted and should not be considered as verified clinical evidence.

Possible Veregen side effects / adverse reactions in 10 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-12

Patient: 10 year old male

Reactions: OFF Label USE, Photosensitivity Reaction

Suspect drug(s):
Veregen



Possible Veregen side effects / adverse reactions in 10 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-21

Patient: 10 year old male

Reactions: Photosensitivity Reaction, OFF Label USE

Suspect drug(s):
Veregen



Possible Veregen side effects / adverse reactions in 10 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-10

Patient: 10 year old male

Reactions: OFF Label USE, Photosensitivity Reaction

Suspect drug(s):
Veregen



See index of all Veregen side effect reports >>

Drug label data at the top of this Page last updated: 2012-11-27

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