SAFETY NOTICE

Isotretinoin must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking isotretinoin in any amount, even for a short period of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected. Because of this toxicity, isotretinoin can only be marketed under a special restricted distribution program. This program is called iPLEDGE™. Under this program, prescribers must be registered and activated with the iPLEDGE Program and can prescribe isotretinoin only to registered patients who meet all the requirements of iPLEDGE. Isotretinoin can be dispensed only by a pharmacy registered and activated with iPLEDGE. Registered and activated pharmacies can only receive isotretinoin from wholesalers registered with iPLEDGE.

Patients on isotretinoin have been known to become depressed or to develop other serious mental health problems. Some people have had thoughts of hurting themselves or putting an end to their own lives. Some people tried to end their own lives and some have ended their own lives. There have been reports that people on isotretinoin were aggressive or violent. No one knows if isotretinoin caused these problems or behaviors or if they would have happened even if the person did not take isotretinoin.

Isotretinoin use has been associated with pseudotumor cerebri, a condition caused by increased pressure on the brain. This condition may occur more often in patients also taking tetracycline. Patients should be aware of other serious side effects, including problems with the skin, pancreas, liver, stomach, bones, muscles, hearing, vision, lipids, allergic reactions, blood sugar, or red and white blood cells. The most common, less serious adverse events include dry skin, chapped lips, dry eyes, and dry nose that may lead to nosebleeds. Patients should be advised about these adverse events and routinely monitored by a doctor during treatment with isotretinoin.

Please refer to the isotretinoin package inserts for full prescribing and dispensing instructions.