Regulatory actions for new signals – EMA PRAC updates

Lisdexamfetamine – QT prolongation and cardiac arrhythmia:

Lisdexamfetamine has shown to prolong the QTc interval in some patients. It should be used with caution in patients with prolongation of the QTc interval, in patients treated with drugs affecting the QTc interval, or in patients with relevant pre-existing cardiac disease or electrolyte disturbances.

Due to this signal, special warnings and precautions, undesirable effects, package leaflet and possible side effects sections were updated.

Tumour necrosis factor alpha inhibitors: adalimumab; certolizumab pegol; etanercept; golimumab; infliximab –
Kaposi’s sarcoma:

Below product information updated for this signal:

Summary of product characteristics
4.8. Undesirable effects
Neoplasms benign, malignant and unspecified (including cysts and polyps)
Frequency not known: Kaposi’s sarcoma
Package leaflet

Possible side effects:
Not known (frequency cannot be estimated from the available data): Kaposi’s sarcoma, a rare cancer related to infection with human herpes virus 8. Kaposi’s sarcoma most commonly appears as purple lesions on the skin.

Reference: https://www.ema.europa.eu/documents/prac-recommendation/new-product-information-wording-extracts-prac-recommendations-signals-adopted-6-9-july-2020-prac_en.pdf