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THALOMID (thalidomide) - gov fda accessdata www - accessdata fda

THALOMID (thalidomide) - gov fda accessdata www - accessdata fda 2025

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The document is a revised package insert for THALOMID (thalidomide) capsules, detailing the severe risks associated with its use during pregnancy, including life-threatening birth defects. It outlines the strict distribution program (S.T.E.P.S.) required for prescribing and dispensing the drug, emphasizing that it should only be used by registered prescribers and pharmacists. The insert includes comprehensive information on contraindications, necessary precautions for women of childbearing potential, dosing guidelines, potential side effects, and requirements for patient consent and monitoring.

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What is the warning of Thalomid?

Note: Thalomid (thalidomide) has a black box warning for embryo-fetal toxicity and venous thromboembolism. Thalomid can cause severe birth defects or embryo-fetal death if taken during pregnancy. Thalomid should never be used by women who are pregnant or who could become pregnant while taking the drug.

How much does Thalomid cost?

Oral Capsule QuantityPer unitPrice 10 $197.21 $1,972.07 280 $178.45 $49,967.27

Who should not take thalomid?

Thalidomide must not be taken by women who are pregnant or who could become pregnant while taking this medication. Even a single dose of thalidomide taken during pregnancy can cause severe birth defects (physical problems present in the baby at birth) or death of the unborn baby.

Was thalidomide ever approved by FDA?

The 1962 drug amendments bill passed that year to change drug regulation (here). In 1998, the FDA approved thalidomide as a prescription drug for the treatment of myeloma and leprosy, with severe use warning labels for the drug here and here .

THALOMID (thalidomide) - gov fda accessdata www - accessdata fda 2025

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