Pomalyst Side Efffects May Include Birth Defect Risk, U.K. Doctors Warned

The makers of the cancer drug Pomalyst are warning doctors in the U.K. that the drug, known there as Imnovid, could result in birth defects that put newborns’ lives at risk.  

According to report by PharmaTimes, Celgene Corp. sent a letter to healthcare professionals in the U.K. warning that the active ingredient, pomalidomide, is structurally similar to thalidomide; a drug known to cause birth defects. The drug was approved in the U.K. in August. It has been on the U.S. market since February.

It does not appear that any similar letter has been sent physicians in the U.S. However, the drug, approved to treat multiple myeloma, was released in the U.S. with a black box warning that it is a chemical analogue of thalidomide. The FDA warned that women of a child-bearing age who could get pregnant must be tested to confirm that they are not pregnant before taking Pomalyst and requires both men and women taking the drug to comply with contraception requirements.

Because of the risk of birth defects, Pomalyst is only available in the U.S. through a Risk Evaluation and Mitigation Strategy (REMS).

Thalidomide was first released as a morning sickness drug in 1957. Four years later, it was removed from the market after it was determined that the thalidomide caused major birth defects when used during pregnancy. It was the first product that established medications could cross the placental barrier and cause harm to a fetus.

It is estimated that between 10,000 and 20,000 children were born worldwide with birth defects from thalidomide. It’s impact was limited in the United States because the FDA denied the drug approval, saying that it needed to be more thoroughly tested. However, the drug was given to doctors in the U.S. during its clinical testing phase and it is unclear how many children it affected.

Thalidomide is sold under the brand name Thalomid and is used for the treatment of multiple myeloma. In September 2012, the German company that initially marketed the drug issued an apology to those affected by thalidomide birth defects and commissioned a statue in Stolberg, Germany in honor of the drug’s victims.