FDA Alerts
FDA Drug Safety Communication: Rosiglitazone-containing Medicines
The U.S. Food and Drug Administration (FDA) is informing the public of new restrictions to the prescribing and use of rosiglitazone-containing medicines.
FDA warns about counterfeit ExtenZe dietary supplements
The U.S. Food and Drug Administration is warning consumers about a potentially harmful product represented as “ExtenZe ,” a dietary supplement for male sexual enhancement. The counterfeit product looks similar to the actual product, but contains hidden ingredients that can cause serious harm to consumers.
FDA approves new treatment for Type 2 diabetes
The U.S. Food and Drug Administration today approved Tradjenta ( linagliptin ) tablets, used with diet and exercise, to improve blood glucose control in adults with Type 2 diabetes.
Defibtech Lifeline and ReviveR Automated External Defibrillators (AEDs): Recall
AUDIENCE: Emergency Medicine, Risk Manager
ISSUE: Devices subject to this recall include Model DDU-100 series with software version 2.004 or earlier, sold under the brand names Lifeline and ReviveR . AEDs using software version 2.004 or earlier may cause the device to cancel shock during the charging process. Failure to provide appropriate therapy may result in failure to resuscitate the patient.
BACKGROUND: AEDs are used on victims of sudden cardiac arrest when the patient is unconscious, unresponsive and not breathing.
RECOMMENDATION: Defibtech will provide customers with a fr...
Public Notification: “Slim Xtreme Herbal Slimming Capsule” Contains Undeclared Drug Ingredient
The Food and Drug Administration (FDA) is advising consumers not to purchase or use “Slim Xtreme Herbal Slimming Capsule,” a product for weight loss sold on various websites and distributed by Globe All Wellness. The company falsely claims on the label that the product is “100% natural.”
FDA laboratory analysis confirmed that “Slim Xtreme Herbal Slimming Capsule” contains sibutramine . Sibutramine is a controlled substance that was withdrawn from the U.S. market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substa...
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 issues first new rules under Food Safety Modernization Act
The U.S. Food and Drug Administration (FDA) today announced two new regulations that will help ensure the safety and security of foods in the United States.
New Diabetes Drug
As diabetes becomes a bigger and bigger problem, it is welcome news when new treatments for the disease become available. The FDA has approved a new drug to help patients with type 2 diabetes control their blood sugar.
Heartburn Drug Clogs the Pipes
The FDA is warning health care professionals that Teva - a drug used to treat gut problems like heartburn - can clog syringes and feeding tubes, which can end up harming patients.