FDA Warning Issued for Picato Gel

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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The FDA has issued a safety warning for Picato (ingenol) topical gel, used to treat actinic keratosis.

According to the warning issued August 21, 2015, there have been recent reports that Picato gel can cause severe allergic skin reactions and shingles.

Is there anything unique about Picato as an actinic keratosis treatment?
Picato gel only requires 2 to 3 consecutive days of dosing, which is the fastest course of therapy of any topical actinic keratosis treatment.

What is actinic keratosis?

Actinic keratosis or AK is a rough, scaly patch of skin that develops due to years of sun exposure. A small percentage of actinic keratosis spots can actually turn into skin cancer.

Common places for actinic keratosis to develop include face, lips, ears, scalp, neck, backs of hands, and forearms. You can lower your risk for AK by decreasing the amount of time you spend in the sun and shielding your skin with SPF sunscreen and protective clothing.

Why exactly was the FDA safety warning issued for Picato?

There have been reports of severe allergic reactions and shingles associated with the use of Picato gel. These reports included some cases of severe eye injuries and skin reactions, which has prompted the FDA to require the Picato label to be changed to include information on these new warnings and risks.

You should be aware though—several of the injuries were due to improper use. Picato is not to be applied in, near, and around the mouth, lips, or eye area. Also, be extra careful if you’re applying make-up or using contact lenses after applying Picato. Accidental transfer of the gel from the hands (even after washing) is possible, so you’ll want to be extra careful to prevent a reaction.

Should I stop using Picato?

No! Do not stop using your medication without speaking with your doctor. However, it’s important to remember to only apply Picato gel as it’s intended to be used, due to the possibility of severe skin reactions and eye injuries.

Want to find out more?

The drug safety warning from the FDA on Picato can be found here.

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