Adverse reactions : תופעות לוואי

4.8    Undesirable effects

The mostly skin related adverse reactions reported were primarily mild in intensity and resolved without discontinuation of Vaniqa or initiation of medical treatment. The most frequently reported adverse reaction was acne, which was generally mild. In the vehicle controlled trials (n= 596), acne was observed in 41% of patients at baseline; 7% of patients treated with Vaniqa and 8% treated with vehicle experienced a worsening of their condition. Of those with no acne at baseline, similar percentages (14%) reported acne following treatment with Vaniqa or vehicle.
The following listing notes the frequency of adverse skin reactions seen in clinical trials, according to MedDRA convention. MedDRA conventions for frequency are very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data) including isolated reports.
Note that over 1350 patients were treated with Vaniqa in these trials for 6 months to one year, while only slightly more than 200 patients were treated with vehicle for 6 months. Most events were reported at similar rates between Vaniqa and vehicle. The skin effects of burning, stinging, tingling, rash and erythema were reported at higher levels in Vaniqa treated patients compared to vehicle, as indicated by the asterisk (*).

Frequency of adverse skin reactions seen in Vaniqa clinical trials, (according to MedDRA frequency convention).

Skin and subcutaneous tissue disorders

Very common              Acne
(≥ 1/10)
Common                   Pseudofolliculitis barbae, alopecia, stinging skin*, burning skin*, dry skin, (≥1/100 to <1/10)        pruritus, erythema*, tingling skin*, irritated skin, rash*, folliculitis 
Uncommon                 Ingrown hair, oedema face, dermatitis, oedema mouth, papular rash, bleeding (≥1/1,000 to <1/100)     skin, herpes simplex, eczema, cheilitis, furunculosis, contact dermatitis, abnormal hair texture and abnormal hair growth, hypopigmentation, flushing skin, lip numbness, skin soreness
Rare                     Rosacea, seborrheic dermatitis, skin neoplasm, maculopapular rash, skin (≥1/10,000 to            cysts, vesiculobullous rash, skin disorder, hirsutism, skin tightness <1/1,000)

Paediatric population
The adverse reactions observed in adolescents are similar to the ones observed in adults.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il