Safety alert for actinic keratosis gel

Product information on ingenol mebutate – Picato gel used to treat actinic keratosis – has been updated to warn of adverse events including ophthalmic injury and reactivation of herpes zoster.

It follows safety concerns in the US about severe allergic reactions including anaphylaxis, shingles and eye injury.

Some incidents were associated with misuse of the gel, the TGA says in its latest Medicines Safety Update.

The regulator is urging doctors to provide patients with clear instructions on how to use the gel, and to consider giving them a copy of the CMI.