Thoughts about a Possible Common Thread Running Through Drugs that Cause Devastating Skin Disease
Posted by
Armand RossettiOctober 02, 2008 10:58 AMTags: Revlimid,
lenalidomide,
thalisomide,
cancerous,
myeloma,
dexamethasone,
sheskin,
celgene,
RevAssist,
carbamazepine,
provigil,
trileptal,
dilantin
REVLIMID (
cells. Revlimid is used in combination with Dexamethasone, a synthetic steroid with powerful anti-inflammatory effects.
Between 1957 and 1969, physicians in almost 50 countries prescribed Thalidomide to pregnant women as a sleep aid. However Thalidomide reached market without prior adequate testing to assess its safety. As a result, approximately 10,000 children were born with severe abnormalities.
In 1964, Israeli physician Jacob Sheskin used a left over bottle of Thalidomide to treat a critically ill patient suffering with leprosy. In Dr. Sheskin's attempt to help his patient to sleep, he observed that the patient began to make progress. That observation led to a successful clinical trial. In 1991, Dr. Gills Kaplan determined that Thalidomide inhibited tumor necrosis factor, and she partnered with Celgene Corporation to seek further development for Thalidomide. Later, Celgene developed Revlimid, a substantially more powerful analogue, having fewer side effects.
Revlimid gained FDA approval as a new drug application (NDA) on December 27, 2005. Later, the FDA further cleared Revlimid on June 29, 2006 for use in combination with Dexamethasone in patients with multiple myeloma who have received at least one prior therapy. While laboratory tests have suggested that Revlimid is not tetratogenic, Revlimid is categorized as such because it has structural similarities to Thalidomide. Given the uncertainty of this danger, the FDA requires restricted distribution through the RevAssistSM program, which requires that prescribers register with RevAssist, pharmacies contract with RevAssist, and that Patients enroll in RevAssist.
Despite special distribution requirements, the FDA has recently included Revlimid on a list of 20 prescription drugs under investigation for potential safety problems. In addition, the FDA has shed light on a postmarket safety review, linking serious skin reactions, including reports of Stevens Johnson syndrome (SJS) and similar skin conditions.
Revlimid, however, is not alone in this respect. The FDA has warned consumers that
(an anti-epileptic drug also known as Tegretol) can also cause SJS. The drug-related skin disease is more prevalent among patients of Asian ancestry. However, it is important to note that patients afflicted with skin diseases as a result of using carbamazepine will show signs of the disease within 90 days of first taking the drug. If skin reactions do not appear within ninety days, there is minimal risk that those diseases will appear thereafter.
The FDA has found the same to be true for
(phenytoin) Injection, and a few other similar drugs.
Just out of curiosity, I took a look at the chemical structures for the drugs under discussion:
Dilantin;
Provigil;
Trileptal;
carbamazepine;
lenalidomide; and
Thalidomide.
Does a reactive commonality exist, somewhere?