The U.S. Food and Drug Administration today approved an application from Medtronic for revised labeling for two cardiac resynchronization pacemakers (CRT-P) and eight cardiac resynchronization defibrillators (CRT-D), expanding the indication for use to patients with atrioventricular (AV) block and less severe heart failure.

The U.S. Food and Drug Administration is warning consumers to immediately stop using Zi Xiu Tang Bee Pollen, marketed as a product for weight loss and body reshaping. The product contains at least one potentially harmful active pharmaceutical ingredient that is not listed on the product’s label.

The U.S. Food and Drug Administration today approved a prescription treatment that can be used by family or caregivers to treat a person known or suspected to have had an opioid overdose. Evzio (naloxone hydrochloride injection) rapidly delivers a single dose of the drug naloxone via a hand-held auto-injector that can be carried in a pocket or stored in a medicine chest.

For more than a decade, the U.S. Food and Drug Administration has been working to address the important public health problems associated with the misuse, abuse, addiction and overdose of opioid analgesics, while at the same time working to ensure continued access to effective and appropriate medications for millions of Americans currently suffering from pain. I firmly believe that these goals are compatible, and that actions to address one should not be at the expense of the other.

The U.S. Department of Health and Human Services (HHS) today released a draft report that includes a proposed strategy and recommendations for a risk-based regulatory framework for health information technology (health IT) that promotes product innovation while maintaining appropriate patient protections and avoiding regulatory duplication. The congressionally-mandated report proposes to clarify federal regulatory oversight of health IT products based on a product’s function and the potential risk to patients who use it.

Today, the U.S. Food and Drug Administration allowed marketing of an expandable, multi-sponge wound dressing to control the bleeding from certain types of wounds received in battle. For military use only, the XSTAT is a temporary dressing for wounds in areas that a tourniquet cannot be placed, such as the groin or armpit. The dressing can be used up to four hours, which could allow time for the patient to receive surgical care.

The U.S. Food and Drug Administration recently approved Oralair to treat allergic rhinitis (hay fever) with or without conjunctivitis (eye inflammation) that is induced by certain grass pollens in people ages 10 through 65 years. Oralair is the first sublingual (under the tongue) allergen extract approved in the United States. After administration of the first dose at the health care provider’s office, where the patient can be observed for potential adverse reactions, Oralair can be taken at home.

The U.S. Food and Drug Administration recently ordered Jensen’s Old Fashioned Smokehouse Inc., a processor of smoked fish products in Seattle, Wash., to stop processing, preparing, packing, holding and distributing any food at or from its facility.

Today, the U.S. Food and Drug Administration approved Topamax (topiramate) for prevention (prophylaxis) of migraine headaches in adolescents ages 12 to 17. This is the first FDA approval of a drug for migraine prevention in this age group. The medication is taken on a daily basis to reduce the frequency of migraine headaches.