FDA News & Alerts
FDA Reports Outbreak Related to Raw Milk
Latest outbreak of campylobacteriosis in Midwest is linked to unpasteurized product. The U.S. Food and Drug Administration, along with several state agencies, is alerting consumers to an outbreak of campylobacteriosis associated with drinking raw milk. At least 12 confirmed illnesses have been recently reported in Michigan. Symptoms of campylobacteriosis include diarrhea, abdominal pain and fever. The... »
Xifaxan Approved by FDA for Patients with Liver Disease
The U.S. Food and Drug Administration (FDA) today approved the use of Xifaxan for reduction in the risk of the recurrence of overt hepatic encephalopathy (HE) in patients with advanced liver disease. This is a new use for Xifaxan (rifaximin), a drug that has been approved for the treatment of traveler’s diarrhea. Hepatic encephalopathy is... »
Zocor May Increase Muscle Injury Risk
The U.S. Food and Drug Administration today warned patients and healthcare providers about the potential for increased risk of muscle injury from the cholesterol-lowering medication Zocor (simvastatin) 80 mg. Although muscle injury (called myopathy) is a known side effect with all statins, today’s warning highlights the greater risk of developing muscle injury, including rhabdomyolysis, for... »
Rituxan Approved to Treat Chronic Lymphocytic Leukemia
The U.S. Food and Drug Administration (FDA) has approved Rituxan (rituximab) to treat certain patients with chronic lymphocytic leukemia (CLL), a slowly progressing blood and bone marrow cancer. Rituxan, an anti-cancer drug, is intended for patients with CLL who are beginning chemotherapy for the first time and for those who have not responded to other... »
Onglyza, a New Type 2 Diabetes Drug Approved by FDA
The U.S. Food and Drug Administration (FDA) today approved Onglyza (saxagliptin), a once-daily tablet to treat Type 2 diabetes in adults. The medication is intended to be used with diet and exercise to control high blood sugar levels. The hormone insulin keeps blood sugar (glucose) levels within a narrow range in people who don’t have... »
Colchicine for Acute Gout, Familial Mediterranean Fever Approved by FDA
The U.S. Food and Drug Administration (FDA) has approved Mutual Pharmaceutical Company's drug, Colcrys, to treat acute flairs in patients with gout, a recurrent and painful form of arthritis, and patients with familial Mediterranean fever (FMF), an inherited inflammatory disorder. The medication’s active ingredient is colchicine, a complex compound derived from the dried seeds... »
FDA Approves Caldolor – Injectable Form of Ibuprofen
The U.S. Food and Drug Administration today approved Caldolor, the first injectable dosage form of the common pain medication ibuprofen, to treat pain and fever. »
Samsca Approved by FDA to Treat Hyponatremia
The U.S. Food and Drug Administration has approved Samsca tablets (tolvaptan) to treat hyponatremia, an abnormally low concentration of sodium in the blood. “With the approval of Samsca, physicians will have an additional tool to treat hyponatremia,” said Norman Stockbridge, M.D., director of the Division of Cardiovascular and Renal Products in the FDA’s Center for... »
FDA Approves Use of Temporary Pump to Assist Heart’s Right Side
The U.S. Food and Drug Administration(FDA) today approved a Humanitarian Device Exemption (HDE) for the first heart pump that provides certain critically ill patients with temporary support for the right side of the heart. The approval is a first for certain critically ill patients. »
Experimental Malaria Vaccines to be Tested in FDA and PATH-MVI Collaboration
The U.S. Food and Drug Administration has announced a collaboration with the PATH Malaria Vaccine Initiative (PATH-MVI) to develop laboratory tests to better predict the level of safety and effectiveness of experimental malaria vaccines before they are used in human clinical trials. »