1. What happened to brand-name Accutane? The product most commonly known as Accutane (Roaccutane), was pulled off the market by Roche and its subsidiary Hoffman-La Roche in 2009.
2. Why is Accutane no longer available? While the brand name product is no longer available, generic versions of its active ingredient, Isotretinoin, are still available under strict physician and pharmacy restrictions.
3. What are Accutane’s dangerous side effects? Accutane has been linked to serious birth defects, mental health issues such as depression, pyschosis, and suicidal thoughts. See more at the FDA warning label for Accutane.
The Basics (For those who never took CHEM 101):
- Accutane is intended for the treatment of severe acne. Due to its long list of side effects and thousands of lawsuit cases, some manufacturers of these products have stopped selling it.
- According to the FDA, “If the drug is improperly used, it can cause severe side effects, including birth defects. Serious mental health problems have also been reported with isotretinoin use.”
- LabDoor supports the FDA’s efforts to heavily educate those trying to buy Accutane online. Please consult a doctor before considering any medications, especially those, like Accutane, that have publicly been linked to severe side effects.
Intermediate Information (For our favorite amateur researchers):
- Isotretinoin has been marketed under the names such as Accutane, Amnesteem, Claravis, and Storet.
- The FDA’s iPLEDGE program was created to ensure that women who were considering use of Isotretinoin are not pregnant or intending to become pregnant. Accutane’s risk of severe birth defects cause the FDA to allow only patients enrolled in the iPLEDGE program and under the supervision of a doctor to start a Isotretinoin prescription.
Advanced Science (For those MD/Ph.D. geniuses):
- The IUPAC name for the key compound in Accutane is 13-cis-retinoic acid, which sounds familiar to most chemists due to its similarities to retinol, Vitamin A (C20H28O2 vs. C20H30O).
- Institute of Medicine set the Tolerable Upper Intake Level of Vitamin A at 3mg/day for adults. Initial dosages for Accutane is set at levels as high as 20-200mg. This is one potential reason why Accutane side effects can be similar to those of Vitamin A overdose.
- Header Image: Tracie Andrews (Flickr)
- Isotretinoin (marketed as Accutane) Capsule Information – FDA
- Roche Discontinues and Plans to Delist Accutane in the U.S. – Roche USA
- iPLEDGE Program – FDA
- Tolerable Upper Intake Levels – Institute of Medicine
- Claravis Package Insert