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Thalidomide: Research advances in cancer and other conditions
Special procedures required to prevent pregnancy
If you and your doctor decide thalidomide is the right treatment for you, you will need to agree to the terms of a restricted distribution program required by the FDA to prevent birth defects. As part of this program, you will:
- Receive a packet of patient education materials
- Sign a consent form
- Use two forms of contraception and undergo frequent pregnancy testing if you're a woman
- Use a condom if you're a man
If you suspect you're pregnant, stop taking thalidomide and contact your doctor immediately. Remember: No method of birth control is completely reliable except for avoiding sexual intercourse.
Side effects other than birth defects
People taking thalidomide might also experience other side effects, such as:
- Peripheral neuropathy
- Blood clots
- Drowsiness
- Seizures
- Rash
- Dizziness
Take your medication exactly as prescribed by your doctor. Check with your doctor before taking any other prescription or over-the-counter medications.
Creating a safer thalidomide
Drugs that work like thalidomide but have fewer side effects may one day be available. Researchers are working on thalidomide analogs — drugs chemically similar to thalidomide. Lenalidomide (Revlimid) is one such analog. This drug is approved for myelodysplastic syndrome (with 5q- syndrome) and advanced multiple myeloma.
Talk to your doctor if you have concerns about thalidomide. Understanding thalidomide's history, its risks and its potential benefits can help you decide if it's right for you.
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- Rosenbach M, et al. Dermatologic therapeutics: thalidomide. A practical guide. Dermatologic Therapy. 2007;20:175.
- Thalomid (prescribing information). Summit, N.J.: Celgene Corp.; 2007. http://www.thalomid.com/pdf/Thalomid_Pl.pdf. Accessed Oct. 30, 2008.
- Patient information sheet thalidomide (marketed as Thalomid). U.S. Food and Drug Administration Center for Drug Evaluation and Research. http://www.fda.gov/cder/drug/InfoSheets/patient/thalidomidePIS.htm. Accessed Oct. 30, 2008.
- Woodcock J. Supervisory review of NDA 20-785. U.S. Food and Drug Administration Center for Drug Evaluation and Research. http://www.fda.gov/cder/news/thalinfo/20785medr.htm. Accessed Oct. 30, 2008.
- Label and approval history. Drugs@FDA. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#apphist. Accessed Oct. 30, 2008.
- Melchert M, et al. The thalidomide saga. The International Journal of Biochemistry & Cell Biology. 2007;39:1489.
- Revlimid (prescribing information). Summit, N.J.: Celgene Corp.; 2006. http://www.fda.gov/cder/foi/label/2006/021880s001.pdf. Accessed Oct. 31, 2008.
