Undesirable effects

Skin disorders are commonly reported.
Skin: Application site reactions, rashes, pruritus and urticaria, drying, reddening, burning sensations, contact dermatitis. In a clinical trial 236 patients with ankle distortions were treated with 4-5 pump strokes of Diclofenac sodium 4% Spray Gel (DicloFlex®) t.i.d. (120 patients) or placebo (116 patients) for 14 days. The following adverse drug reactions were reported:

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),
not known (cannot be estimated form the available data).

Undesirable effects may be reduced by using the minimum effective dose for the shortest possible duration. The total single dose of product should not exceed 1.0 g (equivalent to 5 pump strokes) of spray. Nevertheless during long term treatment (> three weeks) and/or when treating large areas (i.e. more than 600 square centimetres of the body surface) there is a possibility of systemic adverse reactions. Reactions like abdominal pain, dyspepsia, gastric and renal disorders may occur.

In patients using topical NSAID preparations asthma has been reported rarely. In isolated cases generalised skin rash, hypersensitivity reactions such as angioedema and photosensitivity reactions have been reported.

In a single center, open, repeated-dose, maximum use tolerance study 62 healthy volunteers entered the trial (17).Diclofenac sodium 4% Spray Gel (DicloFlex®) was administered (5 sprays/application) to one knee 4 times per day for a period of 28 consecutive days. The intervals of application were approximately 6 hours. All adverse events were recorded beginning from the time the volunteer first received Diclofenac sodium 4% Spray Gel. At day 7, day 14, day 21 and day 28 of application, a trained dermatological assessor examined the application area of all volunteers and indicated on the case report form if any application site reaction was present. Subjects who reported a side effect or were observed to have an application site reaction were assessed to determine suitability to continue with the study.

Results:

Of the 62 healthy volunteers 2 were discontinued from the study on day 22 due to significant application site reactions. The number of volunteers with application site reactions discovered by the skin assessor were 3 (5%) on day 7, 13 (21%) on day 8, 19 (31%) on day 22, and 17 (27%) on day 28. In addition, 11 subjects (18%) reported one or more application site reactions. The most frequently reported symptoms are listed in Table.

All reports were mild. One male volunteer suffered from a serious adverse event that was considered unrelated to study medication. On day 28 of the study he collapsed due to breathlessness and was taken to the hospital where he was treated with salbutamol and released from the hospital. He was diagnosed with bronchospasm and suffered from an upper respiratory tract infection.