FDA Alerts
FDA Drug Safety Communication: Adcetris (brentuximab vedotin)
The U.S. Food and Drug Administration (FDA) is notifying the public that two additional cases of progressive multifocal leukoencephalopathy ( PML ), a rare but serious brain infection that can result in death, have been reported with the lymphoma drug Adcetris ( brentuximab vedotin ).
FDA Approves First Drug to Treat a Rare Bone Marrow Disease
The U.S. Food and Drug Administration today approved Jakafi ( ruxolitinib ), the first drug approved to specifically treat patients with the bone marrow disease myelofibrosis .
FDA approves Ferriprox
The U.S. Food and Drug Administration today approved Ferriprox ( deferiprone ) to treat patients with iron overload due to blood transfusions in patients with thalassemia , a genetic blood disorder that causes anemia, who had an inadequate response to prior chelation therapy.
FDA approves Ferriprox
The U.S. Food and Drug Administration today approved Ferriprox ( deferiprone ) to treat patients with iron overload due to blood transfusions in patients with thalassemia , a genetic blood disorder that causes anemia, who had an inadequate response to prior chelation therapy.
FDA Approves Soliris For Rare Pediatric Blood Disorder
The U.S. Food and Drug Administration today approved Soliris ( eculizumab ) to treat patients with atypical hemolytic uremic syndrome ( aHUS ), a rare and chronic blood disease that can lead to kidney (renal) failure and is also associated with increased risk of death and stroke.
FDA Drug Safety Communication: Revlimid
The U.S. Food and Drug Administration (FDA) is informing the public that we are aware of results from clinical trials conducted inside and outside the United States that found that patients treated with Revlimid ( lenalidomide ) may be at an increased risk of developing new types of cancer compared to patients who did not take the drug.
FDA is currently reviewing all available information on this potential risk and will communicate any new recommendations once it has completed its review.
At this time, FDA recommends that patients continue their Revlimid treatment as prescribed by their...
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 Approves Xarelto To Reduce Risk Of Blood Clots
On July 1, the U.S. Food and Drug Administration approved Xarelto ( rivaroxaban ) to reduce the risk of blood clots, deep vein thrombosis ( DVT ), and pulmonary embolism (PE) following knee or hip replacement surgery.
Dental Pain Reliever May Be Dangerous
The FDA continues to receive reports about a life-threatening side effect of a dental pain reliever called benzocaine .
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.