FDA Alerts
Revlimid and Risk of New Cancers
The U.S. Food and Drug Administration (FDA) is informing the public of an increased risk of second primary malignancies (new types of cancer) in patients with newly-diagnosed multiple myeloma who received Revlimid ( lenalidomide ).
Cephalon, Inc. Issues Voluntary Nationwide Recall of Treanda
Cephalon , Inc. is voluntarily recalling Treanda ® ( bendamustine HCL ) for Injection 25mg / 8mL ; lot TB30111 , expiration date 12/2012. This product lot is being recalled due to the presence of particulate matter found in a single vial, which has been identified as glass fragments.
FDA Drug Safety Communication: TNF blockers
The U.S. Food and Drug Administration (FDA) is informing the public that it continues to receive reports of a rare cancer of white blood cells (known as h epatosplenic T-Cell lymphoma or HSTCL ), primarily in adolescents and young adults being treated for Crohn’s disease and ulcerative colitis with medicines known as tumor necrosis factor ( TNF ) blockers, as well as with azathioprine , and/or mercaptopurine .
Crohn's disease and ulcerative colitis cause inflammation of the digestive system. Common symptoms are pain in the abdomen, cramps, and diarrhea. Bleeding from the rectum, wei...
FDA Warning: Breast Implants Linked to Rare Cancer
The U.S. Food and Drug Administration today announced a possible association between saline and silicone gel-filled breast implants and anaplastic large cell lymphoma ( ALCL ), a very rare type of cancer.