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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.

8 Alternatives to Accutane according to dermatologist - Miiskin

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

: 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.