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: In the U.S., patients must enroll in the iPLEDGE program , which requires monthly office visits, regular blood tests (to monitor liver function and cholesterol), and strict pregnancy prevention protocols.

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The primary reason for its strict regulation is , meaning it can cause severe, life-altering birth defects if taken during pregnancy. : In the U

Accutane (isotretinoin) is in the United States, the UK, Canada, Australia, or many other regulated healthcare systems . It is a highly potent prescription medication that requires strict medical supervision due to serious potential side effects and legal requirements for risk management programs. Why Accutane is Not OTC It is a highly potent prescription medication that

: Beyond birth defects, Accutane can cause significant changes in liver enzymes, dry skin and eyes, mood changes (including depression), and muscle/joint pain.