USPlabs LLC recalls OxyElite Pro dietary supplements; products linked to liver illnesses
FDA announced that USPlabs LLC, of Dallas, Texas, is recalling certain OxyElite Pro dietary supplement products that the company markets. The company took this action after receiving a letter from the FDA stating that the products have been linked to liver illnesses and that there is a reasonable probability that the products are adulterated. The letter also notified USPlabs that if the company did not initiate a voluntary recall, the FDA could by law order the company to immediately stop distributing the dietary supplements and immediately notify other parties to stop distributing the dietary supplements. More information
FDA asks manufacturer of the leukemia drug Iclusig (ponatinib) to suspend marketing and sales
FDA is providing instructions to health care professionals whose patients have been taking Iclusig (ponatinib) and are benefiting from the drug, on how to continue those patients on the drug. We are working closely with Iclusig’s manufacturer, ARIAD Pharmaceuticals (ARIAD), to avoid interruptions in treatment. At this time, Iclusig treatment may be continued for appropriate patients under an emergency Investigational New Drug (IND) application. More information. This information is a follow up to the FDA Drug Safety Communication: FDA asks manufacturer of the leukemia drug Iclusig (ponatinib) to suspend marketing and sales issued on October 31, 2013
FDA takes two important actions on drug shortages
FDA is taking two actions to further enhance the agency’s ongoing efforts to prevent and resolve drug shortages, a significant public health threat that can delay, and in some cases even deny, critical care for patients. Following the President’s 2011 Executive Order on reducing drug shortages, the number of new shortages in 2012 was 117, down from 251 in 2011. The announcements build on this work. First, the FDA is releasing a strategic plan called for in the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 to improve the agency’s response to imminent or existing shortages, and for longer term approaches for addressing the underlying causes of drug shortages. The plan also highlights opportunities for drug manufacturers and others to prevent drug shortages by promoting and sustaining quality manufacturing. More information
Comunicaciones de la FDA sobre la seguridad de los medicamentos en español
Descargo de responsabilidad: La FDA reconoce la necesidad de proporcionar información sobre seguridad importante en idiomas distintos al inglés. Hacemos lo mejor posible para proporcionar versiones en español precisas y oportunas de nuestras Comunicaciones de Seguridad de Medicamentos. Sin embargo, en caso que existiera discrepancias entre las versiones en ingles y en español, la información contenida en la versión en inglés es la que se considera como versión oficial. Si tiene alguna pregunta, por favor contáctese con Division of Drug Information en druginfo@fda.hhs.gov. Comunicaciones de la FDA
MedWatch: The FDA Safety Information and Adverse Event Reporting Program
For more important safety information on human drug and devices or to report a serious problem, please visit MedWatch.
FDA recognizes the significant public health consequences that can result from drug shortages and takes tremendous efforts within its legal authority to address and prevent drug shortages. These shortages occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. When issues are discovered by the company or the public and reported to FDA or are found by FDA upon inspection, FDA works closely with the firm to address risks involved to prevent harm to patients. FDA also considers the impact a shortage would have on patient care and access and works with the firm to restore supplies while also ensuring safety for patients. More information
Drug Shortages Voluntarily Reported by Manufacturers During the Past 2 Weeks:
Tiopronin (Thiola)
Drug Shortages Resolved During the Past 2 Weeks:
Dexrazoxane Injection
Fluticasone Propionate and Salmetrerol (Advair HFA)
Gazyva for chroniclymphocyticleukemia approved
FDA approved Gazyva (obinutuzumab) for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia (CLL). Gazyva works by helping certain cells in the immune system attack cancer cells. Gazyva is intended to be used with chlorambucil, another drug used to treat patients with CLL.
Gazyva is the first drug with breakthrough therapy designation to receive FDA approval. More information
Aptiom approved to treat seizures in adults
FDA approved Aptiom (eslicarbazepine acetate) as an add-on medication to treat seizures associated with epilepsy. Epilepsy is a brain disorder caused by abnormal or excessive activity in the brain’s nerve cells. Approximately 200,000 new cases of seizures and epilepsy occur in the United States each year. Aptiom is approved for the treatment of partial seizures, the most common type of seizure seen in people with epilepsy. Seizures can cause a wide range of symptoms, including repetitive limb movements, unusual behavior and generalized convulsions with loss of consciousness. Seizures can have serious consequences, including injury and death. More information
For information on drug approvals or to view prescribing information and patient information, please visit Drugs@FDA or DailyMed.
Unique Device Identification System
FDA is issuing a final rule to establish a system to adequately identify devices through distribution and use. This rule requires the label of medical devices to include a unique device identifier (UDI), except where the rule provides for an exception or alternative placement. The labeler must submit product information concerning devices to FDA’s Global Unique Device Identification Database (GUDID), unless subject to an exception or alternative. More information
Janssen Pharmaceuticals, Inc. to plead guilty and pay over $1.6 billion to resolve allegations of misbranding and filing false claims for its schizophrenia drug Risperdal
On behalf of the U.S. Food and Drug Administration, the U.S. Department of Justice today announced a guilty plea agreement with Janssen Pharmaceuticals, Inc., (JPI) of Titusville, N.J., and a $400 million criminal fine for introducing a misbranded drug, Risperdal (risperidone), into interstate commerce. A Johnson & Johnson Company, JPI must also pay $1.25 billion under a separate civil settlement concerning the same drug. The combined criminal plea and civil settlement agreement related to Risperdal totals more than $1.67 billion. More information
Working to improve the communication of important drug safety information about generic drugs, by: Janet Woodcock, M.D., Director of Center for Drug Evaluation and Research
FDA is taking a step today that is intended to improve the communication of important drug safety information about generic drugs to both prescribers and patients.All drug manufacturers are required to keep close tabs on their drugs once they go to market, reviewing all reports of adverse events involving their drug and reporting these findings to FDA.
But currently, only brand name manufacturers are able to independently update and promptly distribute revised drug safety information, also called labeling, and they can distribute that information before FDA has reviewed or approved the change. These updates, which are submitted in changes being effected supplements, ensure that this important safety information gets to the public as quickly as possible.
Personalized Medicine: The Future is Now, by Margaret A. Hamburg, M.D., Commissioner of FDA
The difference between science and science fiction is a line that seems ever harder to distinguish, thanks in part to a host of astonishing advances in medical science that are helping to create a new age of promise and possibility for patients.
Today cancer drugs are increasingly twinned with a diagnostic device that can determine whether a patient will respond to the drug based on their tumor’s genetic characteristics; medical imaging can be used to identify the best implantable device to treat a specific patient with clogged coronary arteries; and progress in regenerative medicine and stem cell therapy using a patient’s own cells could lead to the replacement or regeneration of their missing or damaged tissues. Given these trends, the future of medicine is rapidly approaching the promising level of care and cure once imagined by Hollywood in futuristic dramas like Star Trek.
Personalized Medicine :FDA’s Unique Role and Responsibilities in Personalized Medicine
The term “personalized medicine” is often described as providing “the right patient with the right drug at the right dose at the right time.” More broadly, “personalized medicine” may be thought of as the tailoring of medical treatment to the individual characteristics, needs, and preferences of a patient during all stages of care, including prevention, diagnosis, treatment, and follow-up.Consistent with FDA’s core mission, the agency is working in collaboration with researchers, manufacturers of drugs, medical devices and biologics, health care professionals and others to better understand and adapt to the promise of personalized medicine. FDA’s ongoing efforts to make personalized medicine possible touch on various facets of product development and use including:
FDA advisory committee meetings are free and open to the public. No prior registration is required to attend. Interested persons may present data, information, or views, orally at the meeting, or in writing, on issues pending before the committee.
Other types of meetings listed may require prior registration and fees.
Please visit FDA’s Advisory Committee page to obtain advisory committee meeting agendas, briefing materials, and meeting rosters prior to the meetings. You may also visit this page after meetings to obtain transcripts, presentations, and voting results. For additional information on other agency meetings please visit Meetings, Conferences, & Workshops.
FDA Targets Trans Fat in Processed Foods
More than decade ago, a sea change began in the American diet, with consumers starting to avoid foods with trans fat and companies responding byreducing the amount of trans fat in their products.This evolution began when FDA first proposed in 1999 that manufacturers be required to declare the amount of trans fat on Nutrition Facts labels because of public health concerns. That requirement became effective in 2006. More information or to read press announcement.
Teens and Steroids: A Dangerous Combo
The abuse of anabolic steroids can cause both temporary and permanent injury to anyone using them. Teenagers, whose bodies are still developing, are at heightened risk. An alarming number of them are trying steroids in hopes of improving their athletic prowess or their appearance. Ali Mohamadi, M.D., a medical officer in the Food and Drug Administration’s Division of Metabolism and Endocrinology Products, warns teens and parents about the dangers of steroid use. More information
Hearing Loss Signals Need for Diagnosis
Straining to hear? Do people say you’re talking loudly? Thinking about ordering a hearing aid or sound amplifier from a magazine or late-night TV advertiser?
Doing so could delay the diagnosis of a treatable or serious ear condition and lead to further hearing loss or other complications. “The problem might be as simple as a wax impaction blocking the ear canal, which is easily treated, or at the other end of the spectrum, it could be something as serious as a tumor pressing on the hearing nerve,” says Eric Mann, M.D., Ph.D., clinical deputy director for the Division of Ophthalmic, and Ear, Nose, and Throat Devices at FDA. More information
More Consumer Updates
For previously published Consumer Update articles that are timely and easy-to-read and cover all FDA activities and regulated products. More information
Artículos en Español
Estos artículos para los consumidores incluyen información sobre la Administración de Medicamentos y Alimentos (FDA, Food and Drug Administration) y consejos para llevar una vida saludable. Artículos en Español
Getting Importers’ Pulse About Food Safety Plans, from Michael R. Taylor, Deputy Commissioner for Foods and Veterinary Medicine
My team and I took to the road again recently to reach out to the people who will be most affected by the food safety rules that FDA has proposed this year.
We traveled to Long Beach, Calif. – one of the world’s busiest ports – on Oct. 22 and 23 for a public meeting on the two rules that FDA proposed in July to help prevent contaminated foods from ever reaching U.S. ports. These rules – Foreign Supplier Verification Programs and Accreditation of Third-Party Auditors – would make importers more accountable for food safety and would strengthen our ability to monitor foreign food producers.
Center for Food Safety and Applied Nutrition
The Center for Food Safety and Applied Nutrition, known as CFSAN, carries out the mission of FDA. The Center provides services to consumers, domestic and foreign industry and other outside groups regarding field programs; agency administrative tasks; scientific analysis and support; and policy, planning and handling of critical issues related to food and cosmetics. More information
Food Facts for You
The Center for Food Safety and Applied Nutrition, known as CFSAN, issues food facts for consumers to keep you and your family safe. More information
Pain Medicines for Pets: Know the Risks
Your 9-year-old German Shepherd is limping, and you think that arthritis may be setting in. A trip to the veterinarian proves that you’re right—it’s osteoarthritis, a degeneration of the cartilage and bone that affects joints. The veterinarian prescribes a non-steroidal anti-inflammatory drug (NSAID).NSAIDs are a class of drugs extensively used in both human and veterinary medicine for their anti-fever, anti-inflammatory and pain-relieving properties, and they are the most commonly prescribed pain relievers for animals. Inflammation—the body’s response to irritation or injury—is characterized by redness, warmth, swelling, and pain. NSAIDs work by blocking the production of chemicals produced by the body that play a role in inflammation. More information
Animal Health Literacy
Animal Health Literacy means timely information for the benefit of all animals and their humans. With continuous communication and outreach, the Center for Veterinary Medicine (CVM) strives to enhance the public trust, promote safe and effective use of the animal health products we regulate, and share our scientific endeavors. CVM provides reliable, science-based information to promote animal and human health. More information
CVM Pet Facts
The Center for Veterinary Medicine (CVM) issues medical and feeding fact sheets to keep your pets healthy and safe. More information
Have a question about what the Center for Drug Evaluation and Research (CDER) does? Ask Janet Woodcock, M.D., Director, CDER, FDA
FDA will select some of your questions to answer each month. Due to the volume of e-mails we receive, we won’t be able to answer each question in this format. We may edit your questions for brevity or clarity. More information
healthfinder.gov
Welcome to healthfinder.gov, a government Web site where you will find information and tools to help you and those you care about stay healthy. More information
Tobacco Products Resources for You
Federal resources to help you quit using tobacco products and to help you learn more about youth tobacco prevention, effective treatment for nicotine addiction, and tobacco research and statistics. More information
An interactive tool for educating patients, patient advocates, and consumers on how their medications – both prescription and over-the-counter – and medical devices move from the realm of idea to the realm of the marketplace. More information
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The U.S. Court of Appeals for the 9th Circuit affirmed a $68.5 million judgment Monday for SCV Water for the cleanup of local groundwater contamination in its case against the Whittaker Corporation.
Castaic Union School District is thrilled to announce that Lara Frandzel has been selected to participate in the Teacher Innovator Institute at the Smithsonian’s National Air and Space Museum in Washington, D.C
The city of Santa Clarita’s exciting Concerts in the Park series, presented by Logix Federal Credit Union, makes its highly anticipated return this summer for friends, families and neighbors to gather under the evening sky and enjoy free, live musical performances on Saturdays from July 6 to Aug. 24, at Central Park, located at 27150 Bouquet Canyon Road.
The U.S. Court of Appeals for the 9th Circuit affirmed a $68.5 million judgment Monday for SCV Water for the cleanup of local groundwater contamination in its case against the Whittaker Corporation.
Angelo Aleman smacked a pair of home runs as College of the Canyons concluded its three-game series vs. Antelope Valley College with a 10-5 home victory at Mike Gillespie Field on Friday.
Castaic Union School District is thrilled to announce that Lara Frandzel has been selected to participate in the Teacher Innovator Institute at the Smithsonian’s National Air and Space Museum in Washington, D.C
The city of Santa Clarita’s exciting Concerts in the Park series, presented by Logix Federal Credit Union, makes its highly anticipated return this summer for friends, families and neighbors to gather under the evening sky and enjoy free, live musical performances on Saturdays from July 6 to Aug. 24, at Central Park, located at 27150 Bouquet Canyon Road.
The Master's University men's volleyball team left no doubt about it as they swept the OUAZ Spirit 25-22, 25-14, 25-22 in the season finale Saturday in The MacArthur Center.
Join the Greater Los Angeles County Vector Control District online for an engaging conversation with experts in the field as they discuss the latest advancements and future trends in vector control Monday, April 15, from 6 p.m to 7:30 p.m.
In recognition of Mental Health Awareness Month in May, Child & Family Center is presenting a series of four seminars for parents and caregivers of children and teens.
The Los Angeles County Department of Public Health has been notified by the California Department of Public Health of one case of measles in a non-Los Angeles County resident who traveled throughout Los Angeles County from Saturday, March 30 to Sunday, April 1.
California Department of Transportation, along with Valencia-based C.A. Rasmussen, continues to make progress on the Wallis Annenberg Wildlife Crossing.
The Santa Clarita Shakespeare Festival is expanding its 2024 Summer Season to include a weekend of performances at the MAIN in July by members of this summer’s youth Shakespeare Camp.
With the federal and state deadlines for filing and paying taxes approaching in three days, Los Angeles County is also renewing its focus on taxes, with a special focus on enhancing its property tax correction and reimbursement processes.
The Los Angeles County Development Authority will be accepting registrants for its Senior and Family Public Housing Site-Based Waiting Lists, including Orchard Arms Senior Apartments in Valencia, from April 15, 8 a.m. through April 30, 11:59 p.m., or until a sufficient number of registrations have been received, whichever occurs first.
Live jazz music, entertainment by talented William S. Hart Union High School District Students, music by Lance Allyn, be treated to happy hour, plus six seated courses - each one created by a different chef from your favorite local restaurants and paired with fabulous wines, local and statewide.
Local realtor, Racquel Wilder, is hosting a free community paper shredding event Sunday, April 21, from 12 p.m. to 3 p.m., in the parking lot of Congregation Beth Shalom.
A special meeting of the William S. Hart Union High School District’s Governing Board will be held 4:30 p.m. Wednesday, April 17. It will be followed by the regular meeting of the Hart Board at 7 p.m.
The Santa Clarita Planning Commission will hold its regular meeting Tuesday, April 16, at 6 p.m. in City Council Chambers at City Hall,
23920 Valencia Blvd. 1st Floor, Santa Clarita, CA 91355.
Hundreds of residents joined the Santa Clarita City Council and dignitaries on Saturday, Aprl 6, for the grand opening of the city’s newest amenity, Skyline Ranch Park. Marking the 38th park in the community, the 10.5-acre park offers activities for everyone.
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USPlabs LLC recalls OxyElite Pro dietary supplements; products linked to liver illnesses
FDA asks manufacturer of the leukemia drug Iclusig (ponatinib) to suspend marketing and sales
FDA takes two important actions on drug shortages
Comunicaciones de la FDA sobre la seguridad de los medicamentos en español
FDA recognizes the significant public health consequences that can result from drug shortages and takes tremendous efforts within its legal authority to address and prevent drug shortages. These shortages occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. When issues are discovered by the company or the public and reported to FDA or are found by FDA upon inspection, FDA works closely with the firm to address risks involved to prevent harm to patients. FDA also considers the impact a shortage would have on patient care and access and works with the firm to restore supplies while also ensuring safety for patients. 
Gazyva for chronic lymphocytic leukemia approved
FDA Investigates Multistate Outbreak of E. coli O157 Illnesses Possibly Linked to Pre-packaged Salad Products
Janssen Pharmaceuticals, Inc. to plead guilty and pay over $1.6 billion to resolve allegations of misbranding and filing false claims for its schizophrenia drug Risperdal
Working to improve the communication of important drug safety information about generic drugs, by: Janet Woodcock, M.D., Director of Center for Drug Evaluation and Research
Personalized Medicine: The Future is Now, by Margaret A. Hamburg, M.D., Commissioner of FDA
Personalized Medicine :FDA’s Unique Role and Responsibilities in Personalized Medicine
FDA advisory committee meetings are free and open to the public. No prior registration is required to attend. Interested persons may present data, information, or views, orally at the meeting, or in writing, on issues pending before the committee.
Please visit FDA’s 
FDA Targets Trans Fat in Processed Foods
Teens and Steroids: A Dangerous Combo
Hearing Loss Signals Need for Diagnosis
Getting Importers’ Pulse About Food Safety Plans, from Michael R. Taylor, Deputy Commissioner for Foods and Veterinary Medicine
Center for Food Safety and Applied Nutrition
Pain Medicines for Pets: Know the Risks
Animal Health Literacy
Have a question about what the Center for Drug Evaluation and Research (CDER) does? Ask Janet Woodcock, M.D., Director, CDER, FDA
FDA Basics
healthfinder.gov
REAL NAMES ONLY: All posters must use their real individual or business name. This applies equally to Twitter account holders who use a nickname.
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