Help Avoid More Thalidomide Baby Births

Thalidomide is back. With new applications being discovered for this wonder drug from 50 years ago, its use is on the rise and so is the risk of a new generation of Thalidomide Babies. Thalidomide was pulled from the market in 1961 after thousands of babies were born with no arms and/or legs and other severe thalidomide caused birth defects. The FDA approved thalidomide in 1998 for treatment of symptoms associated with leprosy and since then for various AIDS and cancer treatments. They claim to have instituted a very strict control of distribution through a program called “STEPS” which is “System for Thalidomide Education and Prescribing Safety”.

The FDA mandates compliance with “STEPS”, patented by Celgene Corporation, for anyone prescribing, distributing, or receiving thalidomide or derivatives. Some other countries are beginning to adopt STEPS or similar control programs. See the resources at the end of this article for more information on thalidomide past and present, STEPS patents, and FDA information on thalidomide. Consider the following steps to help avoid the occurrence of more Thalidomide Babies.

Step 1: Maintain an awareness of new developments regarding thalidomide uses and regulations. Sign up for news alerts such as Google News or RSS feeds of your favorite news sites.

Step 2: Keep up with the names of thalidomide based drugs. Presently, the most common are Thalomid and Revlimid but in the 1950’s thalidomide was sold under about 40 different names. New derivatives with different names will become available as more pharmaceutical companies begin producing thalidomide-based drugs.

Step 3: The STEPS program basically dictates that all parties handling thalidomide will be registered and comply with proper screening and educational procedures or in the case of the recipient, compliance with adequate birth control measures if applicable. If you have been prescribed a thalidomide drug, be sure your physician and pharmacy is registered, has provided you with all the educational materials, and properly registers you. If any of these components are missing, report the offending non-compliant to the FDA and Celgene Corporation.

Step 4: Keep your eyes and ears open. Do you have a friend, loved one, co-worker, or casual associate that is on new treatment for any of the current thalidomide uses and of childbearing age? Find out if it is a thalidomide-based drug. Acquire as much information as possible about their source (registered?) and how knowledgeable they are of the severe side affects of just one thalidomide capsule on an unborn fetus. This includes men, as it is now known that thalidomide is present in semen.

Step 5: If it appears that they bypassed the system, knowingly or unknowingly, do what is necessary to get the situation corrected. As in step 3, report any offending non-compliant individuals or organizations or get them to a registered physician. If they acquired thalidomide from another country (or live in another country without strict distribution controls) and were not provided with proper information of the potential consequences, therefore taking the situation lightly, educate them as much as possible yourself. Show them pictures of Thalidomide Babies on the net with no arms and legs. Show them the prescribing info and label info readily available on the Celgene web site. Use whatever tactics necessary to ensure their understanding that they CANNOT create or conceive a child while taking thalidomide because one more Thalidomide Baby is one too many.

Warnings:

~ This information is mainly applicable to the United States where the FDA has authority over drug approval and regulation. In countries with lesser or no controls, keep yourself and others educated to help prevent the onset of a new wave of thalidomide caused birth defects.

~ Information provided here is not intended as a substitute for professional assistance and thorough information of thalidomide and STEPS.

~ Read the label thoroughly and carefully on any prescription or over-the-counter drugs. Ask a physician or pharmacist about any information that you do not understand.

Resources:

The Thalidomide Tragedy – Will History Repeat Itself?

http://www.bukisa.com/articles/28712_the-thalidomide-tragedy-will-history-repeat-itself

Thalidomide information on the FDA site

http://www.fda.gov/Cder/news/thalinfo/default.htm

Original Patent for STEPS

http://www.google.com/patents?id=jm8DAAAAEBAJ&dq=6,045,501

Additional Patent for STEPS

http://www.google.com/patents?id=3sUHAAAAEBAJ&dq=6,315,720

Celgene Corporation Support Coordinator

http://www.celgene.com/patient-support/coordinator.aspx

FDA

http://www.fda.gov