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

THALOMID (thalidomide) - gov fda accessdata www - accessdata fda 2026

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The document is a revised package insert for THALOMID (thalidomide) capsules, detailing the severe risks associated with its use, particularly the potential for life-threatening birth defects if taken during pregnancy. It outlines strict guidelines under the S.T.E.P.S. program to prevent fetal exposure, including mandatory contraception for women of childbearing potential and specific prescribing protocols for registered healthcare providers. The insert also discusses the drug's pharmacology, indications for use in treating erythema nodosum leprosum (ENL), contraindications, warnings about adverse effects, and necessary precautions.

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Click ‘Get Form’ to open it in the editor.
Begin by reviewing the introductory section, which outlines the critical warnings regarding thalidomide's potential for severe birth defects. Ensure you understand these risks before proceeding.
Fill out the patient information section accurately, including your name and contact details. This is essential for compliance with the S.T.E.P.S. program.
In the consent section, carefully read each statement regarding pregnancy prevention and sign where indicated. This confirms your understanding of the necessary precautions.
Complete any required fields related to contraception methods being used, ensuring that you select at least one highly effective method and one additional method as specified.
Submit your completed form through our platform for processing. Make sure to save a copy for your records.

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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.

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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 2026

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