Thalidomide and Pregnancy
From Pharmacy Drug Guide
The connection between thaliomide and pregnancy includes a proven history of adverse effects on pregnant women and their children.[1] Thalidomide, sold under the brand name Thalomid, is a prescription drug manufactured for Celgene Corporation in Summit, New Jersey.[2] Thalidomide is supplied in an oral capsule of varying strengths.[3]
Thalidomide was developed in Germany and used internationally from the 1950s until 1961 when the drug was removed from the market after many women who took the drug during pregnancy either experienced fetal death or gave birth to infants with severe birth defects.[1] While never approved in the US, the drug was taken by women who received prescriptions in other countries.[4] Many women were also given thalidomide by their physicians during clinical trials to determine the drug's effectiveness against morning sickness.[5] Thalidomide has other side effects, including the potential for deep vein thrombosis and other pulmonary difficulties.[2]
 Flickr: Karin Dalziel | |
| Brand name | Thalomid[3] |
|---|---|
| Used for | Cancers of blood-forming cells, especially multiple myeloma;[6]also used to treat Kaposi's Sarcoma and has been associated with AIDS treatment[7] |
| Pregnancy Risk Factor | Pregnancy Category X[1] |
| Label instructions | Patients, doctors, and pharmacists working with thalidomide must take part in the S.T.E.P.S. safety program[2] |
| Warnings | Thalidomide has a proven history of causing severe birth defects.[1] |
| Disclaimer | The information provided by PharmacyDrugGuide.com is not a substitute for professional medical advice, diagnosis, or treatment. Do not take any action based on the information on this page without consulting a physician. |
|
| |
Contents |
Thalidomide and Pregnancy
Thalidomide is a drug with teratogenic properties, meaning that it causes developmental abnormalities.[6] [8] Women who took thalidomide while pregnant gave birth to infants with a range of birth defects, including limb anomalies and shortened arms similar to seal flippers, a condition called phocomelia.[9] Even a single capsule of thalidomide can threaten the health of the fetus.[2]
Women who are or may become pregnant must not take thalidomide at all. They must demonstrate negative pregnancy tests immediately before they begin taking the drug and throughout their use of it. Since the drug can be found in semen, the drug warning includes the partners of women who are or may become pregnant. Therefore, all male partners taking thalidomide must use a latex condom during intercourse, even if they have had a successful vasectomy.[2]
Thalidomide Special Marketing
Because of its history of birth defects, thalidomide is carefully marketed. All parties to its use must undergo special training with both oral and written instruction. The manufacturer Celgene has initiated the S.T.E.P.S. program to educate patients and health care professionals about the dangers of misusing thalidomide.[10]
The FDA notes that drugs sold from foreign sources are not FDA approved and regulated, and warns against purchasing these medications that have bypassed important safeguards.[3]
The S.T.E.P.S. Program
Celgene's edcational S.T.E.P.S. program regarding thalidomide, or System for Thalidomide Prescribing and Safety, requires specific and mandatory actions for all patients, whether male or female, as well as for health care professionals. These actions include counseling, registration, and other instructions both for initial thalidomide prescription and for refills.[10]
Thalidomide and Breastfeeding
Women who breastfeed their infants must not take thalidomide. Sufficient studies of thalidomide taken during breastfeeding have not been performed. It is not known if thalidomide is excreted into breast milk or if it harms the breastfeeding baby.[10]
The Pulse: Thalidomide Makes Its Comeback
Also See: Drug Recalls, Accutane and Pregnancy, Marijuana and Pregnancy, Tylenol and Pregnancy, Melatonin and Pregnancy, Plan B Side Effects, Ella Emergency Contraception
|
|
|
|
References
- ↑ 1.0 1.1 1.2 1.3 http://dermatology.cdlib.org/93/reviews/thalidomide/hsu.html
- ↑ 2.0 2.1 2.2 2.3 2.4 http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2eda833b-1357-4ed4-a093-194524fcb061
- ↑ 3.0 3.1 3.2 http://www.fda.gov/downloads/Drugs/DrugSafety/UCM222363.pdf
- ↑ http://www.marchofdimes.com/pregnancy/alcohol_thalidomide.html
- ↑ http://www.birthdefects.org/research/bendectin_1.php
- ↑ 6.0 6.1 http://www.cancer.gov/cancertopics/druginfo/fda-thalidomide
- ↑ http://www.cancer.gov/newscenter/pressreleases/2000/thalidomideks
- ↑ http://www.merriam-webster.com/dictionary/teratogenic
- ↑ http://www.nytimes.com/2010/03/16/science/16limb.html?pagewanted=all
- ↑ 10.0 10.1 10.2 http://www.thalomid.com/steps_program.aspx
