Revlimid Side Effects Linked to Risk of New Cancer: FDA

Federal health officials indicate that recent clinical trials suggest that side effects of Revlimid, which is used to treat blood cancer or bone marrow disorders, may increase the risk that users develop new types of cancer.

On Friday, the FDA announced that they are currently reviewing all available information on the potential Revlimid cancer risk and will communicate any new recommendations once the evaluation is complete. At this time, the agency does not recommend that treatment with Revlimid be delayed, modified or restricted.

Revlimid (lenalidomide) is an immunomodulatory agent approved for treatment of a bone marrow disorder known as myelodysplastic syndrome and for multiple myeloma, which is a type of blood cancer. Originally approved in December 2005, Revlimid has been used by more than 60,000 people.

According to the FDA statement, the agency has become aware of results from clinical trials conducted both inside and outside of the United States that found patients treated with Revlimid may be at an increased risk of developing new malignancies when compared to individuals who did not take the drug. Although the agency recommends that patients continue taking Revlimid as prescribed by their doctors, healthcare providers have been urged to carefully weigh the benefits and risks of Revlimid side effects when prescribing the drug.

In September 2008, the FDA issued a prior safety alert about a potential association between Revlimid and the skin reactions Stevens-Johnson Syndrome (SJS) and Toic Epidermal Necrolysis (TEN). At that time, post-marketing reports had identiifed at least 14 cases of SJS or TEN with Revlimid use.

Stevens-Johnson Syndrome (SJS) is a severe medication reaction, which involves the development of a rash and blisters of the skin, mouth, eyes and genitals, where the skin literally burns from the inside out. The painful condition often requires treatment in an ICU or Burn Unit and could be fatal in severe cases. When the legions cover more than 30% of the body, the skin reaction is typically referred to as Toxic Epidermal Necrolysis (TEN).