Drug of the week series - 15.2

General
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A 30-year-old woman with newly diagnosed multiple myeloma has been taking thalidomide for two months. During a routine follow-up, she reveals that she recently discovered she is 6 weeks pregnant after forgetting to use contraception.

Questions:

  1. What is the most serious fetal risk associated with thalidomide exposure during pregnancy?

  2. What risk management strategy should always be implemented before initiating thalidomide therapy in women of childbearing potential?

MBH/PS

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1.Thalidomide is a powerful teratogen. Exposure during pregnancy can cause severe congenital malformations, especially phocomelia (severely shortened or absent limbs), along with other defects such as ear, eye, and cardiac abnormalities. Fetal death may also occur.

2.Before starting thalidomide in a woman of childbearing potential, a strict pregnancy-prevention program must be implemented

  • Pregnancy testing before treatment and regularly during therapy

  • Effective contraception before, during, and after treatment as required by the relevant risk-management program

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Thalidomide can cause foetal abnormalities leading to underdeveloped body parts of the foetus, such as missing limbs, cleft lip etc.

Taking thalidomide during pregnancy is quite harmful. A women of child bearing age should take it seriously.

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1. Severe teratogenicity is the most serious fetal risk associated with thalidomide exposure during pregnancy. It can cause phocomelia (limb reduction defects), ear and eye abnormalities, congenital heart defects, craniofacial malformations, renal and gastrointestinal defects, and may also lead to spontaneous abortion or fetal death. The highest risk occurs during weeks 3ā€“8 of gestation (organogenesis).

2. A Pregnancy Prevention Program (PPP)/REMS must always be implemented before initiating thalidomide therapy in women of childbearing potential. This includes a negative pregnancy test before treatment, use of two effective contraceptive methods (or complete abstinence), regular pregnancy testing, comprehensive patient counseling, and dispensing the drug only through the approved REMS/controlled access program.

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Thalidomide exposure during pregnancy can cause congenital malformations in the foetus and also cause defects in the eyes, ears, heart, kidneys and other organs.

Before starting this treatment, a pregnancy test should be done and highly effective contraception should be taken even after the treatment starts.

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The most serious fetal risk associated with thalidomide exposure, particularly during the first trimester is severe limb reduction defects, such as missing or shortened limbs and other major congenital malformations affecting the ears, eyes, heart, and gastrointestinal tract.

The mandatory risk management is strict contraception use and regular pregnancy testing even 24 hours before starting the thalidomide therapy.

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  1. The most serious fetal risks are severe teratogenicity, especially limb deformities and other major congenital abnormalities.
  2. Before starting thalidomide, women of childbearing potential must undergo pregnancy testing and use highly effective contraception under a strict pregnancy prevention program.
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  1. Thalidomide is one of the most potent human teratogens known. It can cause Phocomelia: severe limb malformation where hands or feet attach close to the trunk, other limb defects: amelia absence of limbs, micromelia, ear and facial anomalies, eye defects too

2.Pregnancy Prevention Programs may help creating awareness, mandatory use of contraception, patient education, pharmacists should be registered who are dispensing these drugs, these are very important

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1. Fetal risk:Thalidomide can cause severe birth defects, especially limb deformities (phocomelia), and may also lead to fetal death.

2. Risk management:Always ensure a negative pregnancy test, effective contraception, and regular pregnancy monitoring before and during thalidomide therapy.

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