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.

Did You Know?

AT&T Data Breach Impacts Millions of Customers

More than 73 million customers of AT&T may have had their names, addresses, phone numbers, Social Security numbers and other information released on the dark web due to a massive AT&T data breach. Lawsuits are being pursued to obtain financial compensation.

Learn More

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.

Image Credit: |

0 Comments

Share Your Comments

I authorize the above comments be posted on this page*

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

Leadership Development Committee for Suboxone Dental Injury Lawyers Established in Federal MDL
Leadership Development Committee for Suboxone Dental Injury Lawyers Established in Federal MDL (Posted yesterday)

The U.S. District Judge presiding over all Suboxone lawsuits has created a mentorship program to use the litigation to provide some attorneys an opportunity to gain experience in handling complex federal multidistrict litigations.

Gilead Settlement Resolves 2,625 HIV Drug Lawsuits Pending in Federal Courts for $40M
Gilead Settlement Resolves 2,625 HIV Drug Lawsuits Pending in Federal Courts for $40M (Posted 3 days ago)

Gilead says it will pay $40 million to resolve HIV drug lawsuits over Truvada, Atripla, Viread, Stribild and Complera pending in the federal court system, involving claims that the the company sat on safer formulations of the drugs for years to increase profits.