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.
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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).
michaelDecember 16, 2013 at 3:54 pm
My mother died aug 22 of this year (77 yrs old). She had a petscan before starting revlimid . she had been on other chemo drugs for the last year and the petscan showed she had only 3 , 5 mm nodes or smaller . her dr started her on revlimid and 2 weeks in she had a tumor growing on her neck ! the dr (kimmie) decided to increase the dose . 2 weeks into the second cycle she was admitted to the ER ,[Show More]My mother died aug 22 of this year (77 yrs old). She had a petscan before starting revlimid . she had been on other chemo drugs for the last year and the petscan showed she had only 3 , 5 mm nodes or smaller . her dr started her on revlimid and 2 weeks in she had a tumor growing on her neck ! the dr (kimmie) decided to increase the dose . 2 weeks into the second cycle she was admitted to the ER , entire neck swolen so bad she could not breath or swallow . a new petscan was ordered , Results ,,, massive neck tumors , spinal tumor was back and bigger , lung tumors(that she never had before revlimid) !!!!!!!!! just a few weeks before revlimid she was walking , with a walker in the yard , 2 months later she was in hospice . I miss her everyday , was her primary care giver , saw it all happen . just dont always believe drs , sometimes they get paid for doing studies .
DeWongMay 8, 2011 at 3:15 am
My mother died 3 days before this artical was posted. She had taken 2 bottles of this medication and was given a 3rd bottle for treatment of multiple myeloma. She wasn't improving and I took her back to the hospital. Cause of death was malignant lung cancer-origin unknown. It wasn't found 2 months prior to our last visit. Wish I would have read this first.
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