"A US Food and Drug Administration (FDA) advisory panel has backed a new biologic for psoriasis, though the panelists recommended strong warnings about the potential for suicide and self-injurious behavior (SIB) with the drug.
In the event of acute overdosage, SORIATANE must be withdrawn at once. Symptoms of overdose are identical to acute hypervitaminosis A (e.g., headache and vertigo). The acute oral toxicity (LD50) of acitretin in both mice and rats was greater than 4,000 mg per kg.
In one reported case of overdose, a 32-year-old male with Darier's disease took 21 x 25-mg capsules (525-mg single dose). He vomited several hours later but experienced no other ill effects.
All female patients of childbearing potential who have taken an overdose of SORIATANE must: 1) Have a pregnancy test at the time of overdose; 2) Be counseled as per the boxed CONTRAINDICATIONS AND WARNINGS AND PRECAUTIONS sections regarding birth defects and contraceptive use for at least 3 years' duration after the overdose.
Pregnancy Category X
SORIATANE is contraindicated in patients with severely impaired liver or kidney function and in patients with chronic abnormally elevated blood lipid values (see BOXED WARNINGS: Hepatotoxicity, WARNINGS: Lipids and Possible Cardiovascular Effects, and PRECAUTIONS).
An increased risk of hepatitis has been reported to result from combined use of methotrexate and etretinate. Consequently, the combination of methotrexate with SORIATANE is also contraindicated (see PRECAUTIONS: DRUG INTERACTIONS).
Since both SORIATANE and tetracyclines can cause increased intracranial pressure, their combined use is contraindicated (see WARNINGS: Pseudotumor Cerebri).
Last reviewed on RxList: 9/11/2015
Additional Soriatane Information
Soriatane - User Reviews
Soriatane User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.