Wednesday, June 14, 2006

FDA Approves Thalidomide

The ratio of benefits vs. risks of a potential new drug is a main factor in deciding to approve a new drug. However, the acceptable ratio depends on the targeted condition or disease. For instance, numerous adverse effects are often associated with cancer treating medications. Due to the high mortality associated with cancer, these side effects are deemed acceptable compared to the death rates and other serious complications of cancer.
I read an article on entitled “Thalidomide Approved for Cancer Treatment.” On May 25, 2006, the FDA approved the use of thalidomide in treating patients recently diagnosed with multiple myeloma. Thalidomide, in combination with dexamethasone, is to be used in treating multiple myeloma.
In the early sixties when thalidomide was used by pregnant women, it was discovered that thalidomide caused numerous birth defects. Specifically, it stunted the growth of fetal arms and legs and caused eye, ear, heart, and kidney defects. As a result, the use of thalidomide was banned worldwide in 1962.
Even today, with its FDA approval, thalidomide is being marketed under a “restricted distribution program.” Thalidomide labels display multiple warnings about the risk of birth defects. There is also a warning for male patients stating that it is unknown if thalidomide is present in semen. Due to the severe risks associated with thalidomide even the FDA provides information on its website about thalidomide and warns about the drug’s effects: “Do not take this drug if there is any possibility that you are, or may become, pregnant. Just one dose can cause severe birth defects.”
In addition to myeloma, thalidomide is also being examined in clinical trials as a treatment for a variety of solid tumors and blood cancers.
I found it interesting, and concerning, that a drug with such serious side effects will be used in hopes of prolonging the life of multiple myeloma patients. My concern is based on the CNN article’s suggestion that the success of the clinical trials is somewhat questionable and unknown. For the sake of those multiple myeloma patients that will take this medication in hopes of treating their condition, I hope that the efficacy of the drug outweighs the side effects.

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