FDA Alerts
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 Drug Safety Communication: Bisphosphonates and Esophageal Cancer
The U.S. Food and Drug Administration (FDA) is continuing to review data from published studies to evaluate whether use of oral bisphosphonate drugs is associated with an increased risk of cancer of the esophagus (esophageal cancer).
FDA Sheds Light on Sunscreens
T he Food and Drug Administration (FDA) is taking steps to help protect consumers from skin damage caused by excessive sun exposure.
FDA Approves New Breast Cancer Test
The U.S. Food and Drug Administration (FDA) today approved a new genetic test that will help health care professionals determine if women with breast cancer are HER2-positive and, therefore, candidates for Herceptin ( trastuzumab ), a commonly used breast cancer treatment.
FDA Drug Safety Communication: 5-alpha reductase inhibitors (5-ARIs)
The U.S. Food and Drug Administration (FDA) is informing healthcare professionals that the Warnings and Precautions section of the labels for the 5-alpha reductase inhibitor (5-ARI) class of drugs has been revised to include new safety information about the increased risk of being diagnosed with a more serious form of prostate cancer (high-grade prostate cancer).
FDA approves new treatment for rare type of pancreatic cancer
On Thursday, the U.S. Food and Drug Administration (FDA) approved Afinitor ( everolimus ) to treat patients with progressive neuroendocrine tumors located in the pancreas ( PNET ) that cannot be removed by surgery or that have spread to other parts of the body (metastatic).
FDA approves Zytiga for late-stage prostate cancer
The U.S. Food and Drug Administration (FDA) today approved Zytiga ( abiraterone acetate) in combination with prednisone (a steroid) to treat patients with late-stage (metastatic) castration-resistant prostate cancer who have received prior docetaxel (chemotherapy).
FDA Approves New Treatment for Rare Form of Thyroid Cancer
The U.S. Food and Drug Administration (FDA) today approved vandetanib to treat adult patients with late-stage (metastatic) medullary thyroid cancer who are ineligible for surgery and who have disease that is growing or causing symptoms.
3-D Trend in Movies Goes Scientific
The FDA today approved the Selenia Dimensions System, the first X-ray mammography device that provides three-dimensional (3-D) images of the breast for breast cancer screening and diagnosis.
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.