viernes, 31 de agosto de 2012

Press Announcements > FDA approves new treatment for a type of late stage prostate cancer

FDA NEWS RELEASE

For Immediate Release: Aug. 31, 2012
Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA approves new treatment for a type of late stage prostate cancer
The U.S. Food and Drug Administration today approved Xtandi (enzalutamide) to treat men with late-stage (metastatic) castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone.
Approved for prostate cancer patients previously treated with docetaxel, another anti-cancer treatment, Xtandi was reviewed under the FDA’s priority review program. The program provides for an expedited six-month review for drugs that may offer major advances in treatment or that provide a treatment when no adequate therapy exists. Xtandi received FDA approval three months ahead of the product’s prescription drug user fee goal date of Nov. 22, 2012.
“The need for additional treatment options for advanced prostate cancer continues to be important for patients,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research. “Xtandi is the latest treatment for this disease to demonstrate its ability to extend a patient’s life.”
Prostate cancer forms in a gland in the male reproductive system found below the bladder and in front of the rectum. The male sex hormone testosterone stimulates the prostate tumors to grow. According to the National Cancer Institute, an estimated 241,740 men will be diagnosed with prostate cancer and 28,170 will die from the disease in 2012.
The safety and effectiveness of Xtandi was evaluated in a study of 1,199 patients with metastatic castration-resistant prostate cancer who had received prior treatment with docetaxel. The study was designed to measure overall survival (the length of time before death) in men receiving Xtandi compared with men receiving a placebo (sugar pill). The median overall survival for patients receiving Xtandi was 18.4 months, compared with 13.6 months for the patients who received placebo.
The most common side effects observed in study participants taking Xtandi were weakness or fatigue, back pain, diarrhea, joint pain, hot flush, tissue swelling, musculoskeletal pain, headache, upper respiratory infections, dizziness, spinal cord compression and cauda equina syndrome, muscular weakness, difficulty sleeping, lower respiratory infections, blood in urine, tingling sensation, anxiety, and high blood pressure.
Seizures occurred in approximately 1 percent of those receiving Xtandi. Patients in the study who had a seizure stopped Xtandi therapy. The clinical study excluded patients with a history of seizure, an underlying brain injury with loss of consciousness, a temporary decrease in blood to the brain within the past 12 months, a stroke, brain metastases, an abnormal connection of the arteries and veins in the brain, or patients taking medications that may lower the seizure threshold. The safety of Xtandi is unknown in patients with these conditions.
Xtandi will be co-marketed by Astellas Pharma U.S., Inc. of Northbrook, IL and Medivation, Inc. of San Francisco, CA.
For more information:
FDA: Office of Hematology and Oncology Products
FDA: Approved Drugs: Questions and Answers
FDA: Drug Innovation

CDC: West Nile Virus - Education: Training and Materials

Materials | Training

this page offers WNV health education materials for use by health and public health professionals. there is also a self-study training course on mosquitoes of public health importance.

Health Education Materials/Resources

	Information and Guidance for Clinicians
	Educational Materials for Individuals and Communities
	Professional Training Materials

WNV Educational Materials for Individuals and Communities

Materials are in public domain and can be reproduced. To obtain physical copies when available, please contact us.

Brochures and Other Print Materials

West Nile Virus a risk you can do something about.

(225 KB/2 pages)
Spanish version

(371 KB/2 pages)
order online
Designed for distribution to the general public, this brochure briefly covers West Nile virus-related illnesses and focuses on strategies for avoiding mosquito bites. Bold yellow and black design. 4-color, two-sides.

Repellent Use Educational Materials for Lower-Literacy Spanish–Speaking Audiences (2006)
Fotonovela-style outreach materials targeted to migrant agricultural workers or other Spanish-speaking audiences, includes poster, 8 ½ by 11 and pocket-sized materials. Only in Spanish. Limited paper versions available.

“How Do I Choose an Insect Repellent?” (2007)

(173 KB/1 page)
Handout/small poster to help people weed through the options for repellent use against mosquitoes and ticks. Ideal for patient waiting rooms, public health departments, etc. Only available online. 11X17 size

PDF (574KB/1page)

West Nile Virus and Transplant Recipients.

(2 MB/2 pages)
order online
People who have received a solid organ transplant may be at up to 40 times greater risk for developing severe WNV disease if bitten by an infected mosquito. this brochure informs organ transplant recipients of this risk and ways to protect themselves. Ideal for health care providers who see these patients, any group doing outreach to this population and transplant recipients themselves. Limited paper versions available.

Public Service Announcements

“Keep It Close”

30 sec TV and 30 and 15 second radio spots focus on repellent use to reduce disease risk, Produced 2006. 2002 PSA “Tell Mosquitoes to Buzz Off” also available ; requires RealOne Player to view online. Beta (video) and CDs (audio) available.

“Fight the Bite” Toolkit

Toolkit for state and local health departments and other partners to raise awareness about WNV and prevention.
this kit was produced in 2005/2006 and contains strategies for education and outreach, templates for brochures, media and community outreach, a template for conducting a focus group, “Fight the Bite” logos in Spanish and English and other materials. A health department of mosquito control program can have a WNV program in a box with these materials, customizable for local use. Materials online/limited CDs available.

Slide Presentations

All WNV Conf Presentations by year, 2001 - 2006
Presentation topics include: surveillance, lessons learned and future research directions, diagnostics and virology, and welcome and call to order presentation

Training

Self-Study Courses
	Mosquitoes of Public Health Importance and their Control Self-study course 3013-G, Vector-Borne Disease Control
	Cover - page 13(1.04 MB, 16 pages) Pages 14-21(571 KB, 8 pages) Pages 22-44(1.62 MB, 23 pages) Pages 45-57(856 KB, 13 pages) Pages 58-74(1.27 MB, 17 pages) Pages 75-85(661 KB, 11 pages)

CDC: West Nile Virus - QA: Symptoms

CDC: West Nile Virus - QA: Symptoms

mosquito bite?

Reduce your stress and learn how to avoid them in the future:

Symptoms of West Nile Virus

Q. What are the symptoms of West Nile virus (WNV) infection?
A. Infection with WNV can be asymptomtic (no symptoms), or can lead to West Nile fever or severe West Nile disease.

It is estimated that about 20% of people who become infected with WNV will develop West Nile fever. Symptoms include fever, headache, tiredness, and body aches, occasionally with a skin rash (on the trunk of the body) and swollen lymph glands. While the illness can be as short as a few days, even healthy people have reported being sick for several weeks.

The symptoms of severe disease (also called neuroinvasive disease, such as West Nile encephalitis or meningitis or West Nile poliomyelitis) include headache, high fever, neck stiffness, stupor, disorientation, coma, tremors, convulsions, muscle weakness, and paralysis. It is estimated that approximately 1 in 150 persons infected with the West Nile virus will develop a more severe form of disease. Serious illness can occur in people of any age, however people over age 50 and some immunocompromised persons (for example, transplant patients) are at the highest risk for getting severely ill when infected with WNV.

Most people (about 4 out of 5) who are infected with West Nile virus will not develop any type of illness (an asymptomatic infection), however you cannot know ahead of time if you'll get sick or not when infected.

Q. What is the incubation period in humans (i.e., time from infection to onset of disease symptoms) for West Nile disease?
A. Usually 2 to 15 days.

Q. How long do symptoms last?
A. Symptoms of West Nile fever will generally last a few days, although even some healthy people report having the illness last for several weeks. The symptoms of severe disease (encephalitis or meningitis) may last several weeks, although neurological effects may be permanent.

Q. What is meant by West Nile encephalitis, West Nile meningitis, West Nile poliomyelitis, �neuroinvasive disease� and West Nile fever?
A. The most severe type of disease due to a person being infected with West Nile virus is sometimes called �neuroinvasive disease,� because it affects a person's nervous system. Specific types of neuroinvasive disease include: West Nile encephalitis, West Nile meningitis, West Nile meningoencephalitis and West Nile poliomyelitis. Encephalitis refers to an inflammation of the brain, meningitis is an inflammation of the membrane around the brain and the spinal cord, meningoencephalitis refers to inflammation of the brain and the membrane surrounding it, and poliomyelitis refers to an inflammation of the spinal cord.

West Nile Fever is another type of illness that can occur in people who become infected with the virus. It is characterized by fever, headache, tiredness, aches and sometimes rash. Although the illness can be as short as a few days, even healthy people have been sick for several weeks.

Q. If I have West Nile Fever, can it turn into West Nile encephalitis?
A. When someone is infected with West Nile virus (WNV) they will typically have one of three outcomes: No symptoms (most likely), West Nile fever (WNF in about 20% of people) or severe West Nile disease, such as meningitis or encephalitis (less than 1% of those who get infected). If you develop a high fever with severe headache, consult your health care provider.

West Nile fever is characterized by symptoms such as fever, body aches, headache and sometimes swollen lymph glands and rash. West Nile fever generally lasts only a few days, though in some cases symptoms have been reported to last longer, even up to several weeks. West Nile fever does not appear to cause any permanent health effects. There is no specific treatment for WNV infection. People with West Nile fever recover on their own, though symptoms can be relieved through various treatments (such as medication for headache and body aches, etc.).

Some people may develop a brief, WNF-like illness (early symptoms) before they develop more severe disease, though the percentage of patients in whom this occurs is not known.

Occasionally, an infected person may develop more severe disease such as “West Nile encephalitis,” “West Nile meningitis” or “West Nile meningoencephalitis.” Encephalitis refers to an inflammation of the brain, meningitis is an inflammation of the membrane around the brain and the spinal cord, and meningoencephalitis refers to inflammation of the brain and the membrane surrounding it. Although there is no treatment for WNV infection itself, the person with severe disease often needs to be hospitalized. Care may involve nursing IV fluids, respiratory support, and prevention of secondary infections.

CDC West Nile Virus Homepage

CDC West Nile Virus Homepage

Did You Know?

August 31, 2012

Nearly 1,600 cases and 65 deaths from West Nile virus have been reported in the United States this year, the highest year on record since 1999.
West Nile virus can lead to severe health complications, including meningitis, encephalitis, paralysis, and even death.
CDC has a number of health education materials public health professionals can use to inform the public about how to protect themselves from West Nile virus.

Since 1999, more than 30,000 people in the United States have been reported as getting sick with West Nile virus. Infected mosquitoes spread West Nile virus (WNV) that can cause serious, life altering disease.

2012 West Nile virus update: as of August 28

As of August 28, 2012, 48 states have reported West Nile virus infections in people, birds, or mosquitoes. A total of 1,590 cases of West Nile virus disease in people, including 65 deaths*, have been reported to CDC. Of these, 889 (56%) were classified as neuroinvasive disease (such as meningitis or encephalitis) and 701 (44%) were classified as non-neuroinvasive disease.

The 1,590 cases reported thus far in 2012 is the highest number of West Nile virus disease cases reported to CDC through the last week in August since West Nile virus was first detected in the United States in 1999. Over 70 percent of the cases have been reported from six states (Texas, South Dakota, Mississippi, Oklahoma, Louisiana, and Michigan) and over 45 percent of all cases have been reported from Texas.

*One death that was incorrectly entered was removed on 8/30/2012.

West Nile virus
Data and Maps
2012

Map of West Nile Virus Activity by State

Table of WNV human infections

WNV activity reported to ArboNET, by state

WNV activity reported to ArboNET, by county

WNV neuroinvasive disease incidence reported to ArboNET, by state

WNV neuroinvasive disease incidence reported to ArboNET, by county

National & state maps provided by USGS (including county-level data)

1999-2011 Archives

Approved Drugs > Everolimus for Tuberous Sclerosis Complex (TSC)

Everolimus for Tuberous Sclerosis Complex (TSC)

On August 29, 2012, the U. S. Food and Drug Administration granted accelerated approval for everolimus tablets for oral suspension (Afinitor Disperz, Novartis Pharmaceuticals Corp.) for the treatment of pediatric and adult patients with tuberous sclerosis complex (TSC) who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. With this new dosage form, the currently approved indication for treatment of SEGA has been expanded to allow treatment of children less than 3 years of age. The application also provides, a higher starting dose, revisions to dose modifications, and additional safety and efficacy data in the SEGA population.
Afinitor Disperz is the first pediatric formulation to be approved by FDA for the treatment of a tumor occurring primarily during childhood. This new dosage form (tablets for oral suspension) is more rapidly dissolved using smaller volumes of water than the tablet dosage form used in clinical trials and provides for smaller dose increments allowing greater dosing flexibility. This formulation also provides another option for adult patients with SEGA.
On October 29, 2010, everolimus (Afinitor Tablets) received its initial accelerated approval for the treatment of patients with SEGA associated with TSC who require therapeutic intervention and are not candidates for curative surgical resection. The approval was based on demonstration of a ≥50% reduction in SEGA tumor volume in 9 of 28 patients aged 3-34 years (median age 11 years) enrolled in a single arm trial. The starting dose utilized in this clinical trial was 3 mg/m2, with therapeutic drug monitoring to achieve and maintain therapeutic trough everolimus concentrations.
Today’s approval also provides the results of a randomized, double-blind, placebo controlled trial in pediatric and adult patients with SEGA, which examined a higher starting dose (4.5 mg/m2/day) and enrolled patients less than 3 years of age. In the randomized trial, 78 patients were randomized to receive everolimus and 39 to receive placebo. The median age of enrolled patients was 9.5 years (range: 0.8 to 26 years). The primary outcome measure was “SEGA Response Rate,” as determined by an independent central radiology review panel 6 months after the last patient was randomized. SEGA response was defined as a ≥50% reduction in the sum of the volumes of SEGA target lesions relative to baseline, in the absence of worsening of non-target SEGA lesions, a new SEGA lesion ≥ 1 cm, or new or worsening hydrocephalus.
SEGA responses were observed in 27 of 78 patients (35%, 95% CI: 24, 46) in the everolimus arm and none of the 39 patients (95% CI: 0, 9) in the placebo arm (p < 0.0001). With a median follow-up duration of 8.4 months for the overall study population, all responses were ongoing and the median response duration was 5.3 months (range: 2.1 to 8.4 months) in Afinitor-treated patients.
In the randomized trial, the most common adverse reactions in patients receiving everolimus (incidence ≥ 20%) were stomatitis, respiratory tract infection, pyrexia, vomiting, rash, and anxiety, aggression or other behavioral disturbances. The most common (≥ 2%) grade 3-4 adverse reactions were stomatitis, pyrexia, pneumonia, gastroenteritis, aggression, agitation, and amenorrhea.
Serious adverse events were reported for 19 (24%) patients in the everolimus group and 5 (13%) patients in the placebo group during the double blind period of the randomized study. The most common serious adverse event (reported in ≥ 3 patients and occurring more frequently in the everolimus group) was pyrexia. Serious adverse events due to infections were more common in patients < 3 years of age; a total of 6 of 13 patients < 3 years who received everolimus had at least one serious adverse event due to infection, compared to 2 of 7 patients < 3 years who received placebo. No deaths occurred in either treatment group.
The recommended starting dose of Afinitor Tablets and Afinitor Disperz for adult and pediatric patients with SEGA is now 4.5 mg/m2/day, with subsequent dosing based on therapeutic drug monitoring to achieve and maintain everolimus trough levels of 5 to 15 ng/mL. Product labeling has also been revised to include more specific dosing guidance in patients requiring concomitant medications and frequency of therapeutic drug monitoring.
The long term effects of Afinitor Tablets and Afinitor Disperz on growth and pubertal development are unknown. Confirmatory studies are underway to further evaluate the long term safety and effectiveness of everolimus in adult and pediatric patients with SEGA.
Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions and contraindications is available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203985s000lbl.pdf

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA's MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).

Rheumatoid Arthritis

Also called: RA

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Rheumatoid arthritis (RA) is a form of arthritis that causes pain, swelling, stiffness and loss of function in your joints. It can affect any joint but is common in the wrist and fingers. More women than men get rheumatoid arthritis. It often starts between ages 25 and 55. You might have the disease for only a short time, or symptoms might come and go. The severe form can last a lifetime.
Rheumatoid arthritis is different from osteoarthritis, the common arthritis that often comes with older age. RA can affect body parts besides joints, such as your eyes, mouth and lungs. RA is an autoimmune disease, which means the arthritis results from your immune system attacking your body's own tissues.
No one knows what causes rheumatoid arthritis. Genes, environment and hormones might contribute. Treatments include medicine, lifestyle changes and surgery. These can slow or stop joint damage and reduce pain and swelling.

NIH: National Institute of Arthritis and Musculoskeletal and Skin Diseases