TGA urges caution with ingenol mebutate
The product information on ingenol mebutate has been updated to warn of adverse events including ophthalmic injury and reactivation of herpes zoster.
This follows safety concerns in the US about severe allergic reactions to the medication, marketed as Picato gel and used to treat actinic keratosis. Reactions have included 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 says patients should be given clear instructions on how to use the gel.