The US Food and Drug Administration (FDA) on December 15 approved Cyanokit (containing the drug hydroxocobalamin, intravenous tubing and a sterile spike for reconstituting the drug product with saline) for the treatment of known or suspected cyanide poisoning.  The approval, which is based on evidence of the drug's effectiveness when tested in animals, improves the nation's ability to respond to emergencies, including a potential attack by terrorists.

"Cyanide is a potent poison and one of the substances that could be used in a chemical attack," said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research.  "Today's approval is yet another measure to counter the threat of terrorism, which is a critical component of FDA's public health mission."

The U. S. Food and Drug Administration (FDA) reminds consumers to pay special attention to the handling of eggs and preparation of foods that contain eggs during this holiday season.  Some holiday favorites, such as cookie dough, homemade eggnog, and some types of stuffing, may contain eggs that are raw or undercooked.  Eggs sometimes contain a bacteria called Salmonella enteriditis (SE), which can cause illness if eggs are not handled and cooked properly.  An FDA national survey of consumer food safety practices, the 2006 FDA/FSIS Food Safety Survey, found that cookie dough is one of the major sources of raw egg in the American diet, and that only three percent of respondents always use a food thermometer when they cook baked egg dishes such as stuffing.

The U.S. Food and Drug Administration (FDA) on December 15 approved Celebrex (celecoxib) for a new use - the relief of the signs and symptoms of Juvenile Rheumatoid Arthritis (JRA) in patients two years of age and older.  Today's approval follows the November 29 meeting of FDA's Arthritis Advisory Committee, in which the committee voted 15 to 1 in favor of approval of this product. This is not good news.

JRA is an autoimmune disease that affects approximately 30,000 to 60,000 children in the United States.  The disease is associated with joint swelling, pain, decreased range of motion and abnormalities of growth and development.  In some cases, systemic complications may occur including uveitis, a chronic inflammation of the eye.  In severe, uncontrolled cases, permanent disability may occur due to progressive joint damage.

The US Food and Drug Administration (FDA) today proposed to amend the labeling regulations on over-the-counter (OTC) Internal Analgesic, Antipyretic, and Antirheumatic (IAAA) drug products to include important safety information regarding the potential for stomach bleeding and liver damage and when to consult a doctor. OTC IAAA drug products, commonly known as acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, naproxen and ketoprofen, are used to treat pain, fever, headaches, and muscle aches. 

To help ensure safe use of OTC products, and to provide consumers with the labeling necessary for them to make more informed medical decisions, FDA is proposing the following label changes:

The US Food and Drug Administration (FDA) has proposed significant regulatory changes to make experimental drugs more widely and easily available to seriously ill patients with no other treatment options and to clarify the circumstances and the costs for which a manufacturer can charge for an experimental drug.  in a clinical trial only to facilitate development of drugs that promise significant advantages over existing therapies, and might not otherwise be developed because of their high cost;

Under the proposed rule, expanded access for experimental drugs would be available to individual patients, small patient groups, and larger populations under a treatment plan when there is no satisfactory alternative therapy to diagnose, monitor or treat the disease or condition.