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02/08/2012 12:42 PM

 
Consumer Health Information Updates     Source: Food and Drug Administration (FDA)

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FDA's MedWatch Safety Alerts: December 2011

FDA gives updated safety information on ADHD drugs and heart disease in adults, dietary supplements that could be contaminated with Salmonella, and a blood thinner that may lead to bleeding problems. Learn about these and other safety alerts at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucmXXXXXX.htm

Jan. 18 Webinar: Reporting Bad Reactions From Cosmetics

Learn how to report a bad reaction to a beauty, personal hygiene or makeup product. Click here to find out how to connect to this 30-minute webinar.

FDA Warns About Stem Cell Claims

Don't be fooled by unscrupulous people who offer hope through unapproved stem cell therapies for diseases or conditions for which few treatments exist.

FDA Targets Risks From Reused Medical Devices

The Food and Drug Administration is taking steps to ensure that reusable medical devices, especially endoscopes, are properly cleaned and disinfected to reduce the risk of infection.

FDA's MedWatch Safety Alerts: November 2011

FDA warns about a home massager that has caused a death, and gives updated safety information on ADHD drugs and heart disease in children, and TNF blocker drugs that have been linked to reports of cancer. Learn about these safety alerts and others: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm283962.htm

Know Concentration Before Giving Acetaminophen to Infants

FDA is urging consumers to examine the labels of liquid infant's acetaminophen to avoid giving the wrong dose as a less concentrated form of the popular medicine arrives in stores.

FDA Targets Gastric Band Weight-Loss Claims

Beware of ads that glamorize this surgery without giving the risks. Learn more at www.fda.gov/ForConsumers/ConsumerUpdates/ucm279301.htm

FDA Widens Look at Arsenic in Apple Juice

FDA is enhancing its surveillance of arsenic in apple juice while remaining confident in the overall safety of this juice for consumers.

FDA and Partners Working to Prevent Surgical Fires

The Food and Drug Administration (FDA) is building a coalition of public and private healthcare organizations to prevent a medical error - the surgical fire.

HCG Diet Products Are Illegal

The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) warn companies that the homeopathic HCG weight-loss products they sell are illegal and make unproven claims.

FDA's MedWatch Safety Alerts: October 2011

FDA warns consumers about a potentially contaminated nasal spray, contact lenses that may cause eye injuries, an unapproved drug sold as a testosterone booster, and more.

Nov. 30 Webinar: How FDA Regulates Imported Products

Learn how FDA handles the millions of shipments of FDA-regulated products imported into the U.S. each year. Click here to find out how to connect to this 30-minute webinar.

Why is the Great American Smokeout Important?

The Great American Smokeout on Nov. 17 is an opportunity for smokers to make a plan to quit smoking. Or even to quit smoking just on that day.

Combating Antibiotic Resistance 

Misuse and overuse of antibiotics have contributed to antibiotic resistance, a phenomenon that reduces or eliminates the effectiveness of antibiotics

How Do You Know If Your Child Has ADHD?

Not all children with ADHD are overactive. Learn the other symptoms and what to do if you suspect your child may have this disorder.

Don't Be Fooled By Health Fraud Scams

FDA has created a new website to help consumers protect themselves from fraudulent health products and schemes.

Improperly Discarded 'Sharps' Can Be Dangerous

Careless at-home disposal of needles, syringes and lancets is putting families and waste-disposal workers in danger.

Lock it Up: Medicine Safety in Your Home

Every year thousands of children are hospitalized and some die after taking medicine not meant for them. FDA pharmacist Connie Jung explains in this video how you can prevent harm by locking your medicine up.

The Straight Poop on Kids and Diarrhea

Diarrhea lasting more than 24 hours can cause your child to become dangerously dehydrated. Learn the signs of dehydration, how to prevent it, and when to call the doctor.

FDA Press Releases Source: Food and Drug Administration (FDA)

FDA and industry reach agreement in principle on medical device user fees

The FDA and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program. The recommendations would authorize the FDA to collect $595 million in user fees over five years, plus adjustments for inflation. Details of the agreement, such as the fee structure, are expected to be finalized soon.

FDA approves Gleevec for expanded use in patients with rare gastrointestinal cancer

The U.S. Food and Drug Administration today granted Gleevec (imatinib) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). Today’s action also highlights an increase in overall patient survival when the drug is taken for 36 months rather than the standard 12 months of treatment.

FDA approves Kalydeco to treat rare form of cystic fibrosis

The U.S. Food and Drug Administration today approved Kalydeco (ivacaftor) for the treatment of a rare form of cystic fibrosis (CF) in patients ages 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator (CFTR) gene.

FDA takes action against New York cheese manufacturer

The U.S. Food and Drug Administration is asking a federal court to prevent a New York cheese manufacturer from operating because of a history of unsanitary conditions and producing cheese in a facility contaminated with Listeria monocytogenes bacteria.

FDA approves new treatment for most common type of skin cancer

Today, Erivedge (vismodegib) was approved by the U.S. Food and Drug Administration to treat adult patients with basal cell carcinoma, the most common type of skin cancer. The drug is intended for use in patients with locally advanced basal cell cancer who are not candidates for surgery or radiation and for patients whose cancer has spread to other parts of the body (metastatic).

FDA approves Inlyta to treat patients with a type of advanced kidney cancer

The U.S. Food and Drug Administration today approved Inlyta (axitinib) to treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer.

Department of Justice files Consent Decree of Permanent injunction against Ranbaxy

Generic drug manufacturer agrees to remedy deviations from the current good manufacturing practice requirements and to correct data integrity problems at numerous facilities

Maine company holds cold smoked salmon product after FDA order

A Maine food processing and storage company destroyed its cold smoked salmon product under the supervision of the U.S. Food and Drug Administration after inspectors found Listeria monocytogenes within the firm’s facility and on processing equipment

FDA permits marketing of first test for risk of rare brain infection in some people treated with Tysabri

Today, the U.S. Food and Drug Administration allowed marketing of the first test to help determine the risk for a rare brain infection called progressive multifocal leukoencephalopathy (PML) in people using the drug Tysabri (natalizumab) to treat multiple sclerosis (MS) or Crohn’s disease (CD).

FDA approves Voraxaze to treat patients with toxic methotrexate levels

The U.S. Food and Drug Administration today approved Voraxaze (glucarpidase) to treat patients with toxic levels of methotrexate in their blood due to kidney failure. Methotrexate is a commonly used cancer chemotherapy drug normally eliminated from the body by the kidneys. However, patients receiving high doses of methotrexate may develop kidney failure.

FDA completes work on three drug user fee programs

The U.S. Food and Drug Administration has completed its recommendations for three user fee programs that will help speed safe and effective drugs and lower-cost generic drug and biosimilar biological products to patients, FDA Commissioner Margaret A. Hamburg, M.D. said today. The recommendations were transmitted to Congress today by Health and Human Services Secretary Kathleen Sebelius.

FDA expands use of endovascular graft to treat aortic tears

The U.S. Food and Drug Administration today expanded the approved usage for an endovascular graft manufactured by W.L. Gore and Associates Inc. to include treatment of life-threatening tears or ruptures of the aorta (thoracic aortic transection). (MB)

FDA to protect important class of antimicrobial drugs for treating human illness

The U.S. Food and Drug Administration today issued an order that prohibits certain uses of the cephalosporin class of antimicrobial drugs in cattle, swine, chickens and turkeys effective April 5, 2012.

FDA expands use of Prevnar 13 vaccine for people ages 50 and older

Prevnar 13, a pneumococcal 13-valent conjugate vaccine, was approved today by the U.S. Food and Drug Administration for people ages 50 years and older to prevent pneumonia and invasive disease caused by the bacterium, Streptococcus pneumoniae.

FDA to approve shared system REMS for TIRF products

The U.S. Food and Drug Administration today approved a single shared Risk Evaluation and Mitigation Strategy (REMS) for the transmucosal immediate-release fentanyl (TIRF) products.

FDA: Chicago-area sandwich manufacturer agrees to stop production

The U.S. Food and Drug Administration announced today that a Chicago-area company has agreed to stop making its ready-to-eat sandwiches and produce after FDA investigators repeatedly found unsanitary conditions and bacterial contamination in the facility.

FDA expands use of HIV drug Isentress to children and adolescents

Isentress (raltegravir) was approved today by the U.S. Food and Drug Administration for use with other antiretroviral drugs for the treatment of HIV-1 infection for children and adolescents ages 2-18.

FDA: Do not use ShoulderFlex Massager

The U.S. Food and Drug Administration is warning consumers again not to use the ShoulderFlex Massager, imported by King International and sold by various companies, due to serious potential health risks.

FDA collaboration to monitor rare eye condition associated with cataract surgery

The U.S. Food and Drug Administration and other government and professional organizations today unveiled a program to monitor medical devices used in cataract surgery in an effort to stem outbreaks of a rare, inflammatory condition associated with the procedure.

FDA approves mechanical cardiac assist device for children with heart failure

The U.S. Food and Drug Administration today approved a medical device that supports the weakened heart of children with heart failure to help keep them alive until a donor for a heart transplant can be found. The mechanical pulsatile cardiac assist device is called the EXCOR Pediatric System, made by a German company, Berlin Heart. The device comes in graduated sizes to fit children from newborns to teens.

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