ACCUTANE (isotretinoin capsules) Rx only CAUSES BIRTH
Signs and symptoms of depression as described in the brochure (“Recognizing Psychiatric Disorders in. Adolescents and Young Adults”)
ACCUTANE (isotretinoin capsules) Rx only CAUSES BIRTH
pregnant because Accutane can cause severe birth defects (see Boxed Accutane may cause depression
Accutane (isotretinoin) Capsules Label
Jun 20 2002 Must have had 2 negative urine or serum pregnancy tests with a ... WARNINGS: Psychiatric Disorders: Accutane may cause depression
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Feb 15 2002 WARNINGS: Psychiatric Disorders: Accutane may cause depression
Medication Guide
FDA MedWatch at 1-800-FDA-1088 and. · the iPLEDGE pregnancy registr at 1-866-495-0654. 2. Serious mental health problems. Accutane may cause: · depression.
NDA 18-662/S-056 Page 11 ACCUTANE (isotretinoin capsules) Rx
Accutane may cause depression psychosis and
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May 2 2002 WARNINGS: Psychiatric Disorders: Accutane may cause depression
1. Indications for Accutane 2 2. Contraindications for Accutane 2 3
mild acne may be candidates for oral antibiotics or Accutane. Accutane may cause depression psychosis and rarely suicidal ideation
NDA 18-662 S-058 Page 4 ACCUTANE (isotretinoin capsules) Rx
Accutane may cause depression psychosis and
o ABSORICA LD is 0.4 to 0.8 mg/kg/day given in two divided doses
ABSORICA LD™ (isotretinoin) capsules for oral use ABSORICA/ABSORICA LD may cause depression
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