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ROCHESTER, Minn. — As winter begins, temperatures drop and hours of daylight fade, it’s not uncommon for people to begin feeling sluggish, moody or stuck in a funk. Those symptoms are typical of someone experiencing seasonal affective disorder, or SAD, a type of depression that typically occurs during the winter. As many as 1 in 5 Americans have SAD, and 75 percent are women, according to the American Psychiatric Association.
Symptoms include sleeping too much, overeating, loss of energy, social withdrawal and difficulty concentrating. People in northern climates are more likely to experience SAD. While many people experience some elements of SAD, Mayo Clinic psychiatrist Mark Frye, M.D., says you should seek professional help if your symptoms begin to affect your ability to perform at work or take a toll on your personal relationships. Seeking help is particularly important if you begin to feel hopeless or have thoughts of self-harm, he says.
Dr. Frye offers these tips to keep your mood and motivation steady throughout the winter:
*Get outside. There is no substitute for natural light. If you work during the day, try to go for a walk during a break or lunch.
*Light therapy boxes can help boost your mood when you’re unable to get outdoors.
*Get regular exercise: at least three times a week for 30 minutes.
*Stay social. Interact with family and friends regularly.
What causes SAD? Sunlight enters the brain through the eyes, stimulating the production of a neurotransmitter, serotonin, that supports nerve cell functioning, including mood. Less light results in lower serotonin levels. Darkness stimulates the production of melatonin, which promotes sleep. It’s the combination of less serotonin and increased amounts of melatonin that causes SAD.
“There are many people who experience winter blues. However, there are those who are experiencing more serious symptoms,” says William Waggle, M.D., a Mayo Clinic Health System psychiatrist who sees patients in Wisconsin. “The good news is that in most cases, we are able to find a treatment plan to help the patient through the winter months.”
About Mayo Clinic:
Mayo Clinic is a nonprofit worldwide leader in medical care, research and education for people from all walks of life. For more information, visitwww.mayoclinic.com and www.mayoclinic.org/news.
Source: Mayo Clinic
Photo credit to: FreeDigitalPhotos.net
FDA Advisory Committee Supports Approval of Gilead’s Truvada® for Reducing the Risk of Acquiring HIV
On Thursday, May 10, 2012 Gilead Sciences, Inc. (Nasdaq:GILD) announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted to support approval of once-daily oral Truvada® (emtricitabine and tenofovir disoproxil fumarate) to reduce the risk of HIV-1 infection among uninfected adults, an HIV prevention strategy called pre-exposure prophylaxis or PrEP. If the FDA decides to approve Truvada for PrEP, it would be the first agent indicated for uninfected individuals to reduce their risk of acquiring HIV.
In response to questions posed to the committee, members voted 19 to 3 in favor of approval for Truvada for PrEP in men who have sex with men; 19 to 2 (with 1 abstaining) in support of use in HIV-uninfected partners in serodiscordant couples; and 12 to 8 (with 2 abstaining) in other individuals at risk for acquiring HIV through sexual activity.
The recommendations of the Advisory Committee are not binding, but will be considered by the FDA as the agency completes its six-month priority review of Gilead’s supplemental New Drug Application (sNDA) of Truvada for PrEP. Gilead submitted the sNDA on December 15, 2011 and the FDA has established a target review date under the Prescription Drug User Fee Act (PDUFA) of June 15, 2012.
The committee’s positive recommendation followed presentations today of efficacy and safety data from several clinical studies of Truvada for PrEP, including two large placebo-controlled Phase 3 trials sponsored by the U.S. National Institutes of Health and the University of Washington, respectively. Several other clinical studies support the use of Truvada for HIV risk reduction.
Truvada was approved by the FDA in 2004 for the treatment of HIV-1 infection and is currently the most-prescribed antiretroviral treatment in the United States. Truvada is not indicated for HIV prevention.
Important Safety Information about Truvada:
WARNINGS: Lactic Acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including Viread®, a component of Truvada, in combination with other antiretrovirals.
Truvada is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of Truvada have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued Truvada. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Truvada. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
New onset or worsening of renal impairment may also occur, including acute renal failure and Fanconi Syndrome. Creatinine clearance should be calculated prior to administering Truvada. Truvada should not be used in patients with severe renal disease (CrCl < 30 mL/min), and routine monitoring of CrCl and serum phosphorous in patients at risk for renal impairment is recommended. Avoid administering concurrently with or with recent use of nephrotoxic drugs.
Truvada should not be co-administered with any other antiretroviral agents for HIV that contain emtricitabine or tenofovir disoproxil fumarate, nor should it be co-administered with products containing lamivudine. Do not administer with Hepsera. Decreases in bone mineral density, fat redistribution and immune reconstitution syndrome may also occur. Common side effects reported during clinical studies with Truvada (in combination with efavirenz) include diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams and rash. Caution should be exercised when co-administering Truvada with didanosine, atazanavir and lopinavir/ritonavir due the potential for toxicity. U.S. full prescribing information for Truvada is available at www.Truvada.com.
About Gilead Sciences:
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Asia Pacific.
Photo credit to: AP Photo/Gilead Sciences.
Sources: BUSINESS WIRE & Gilead Sciences.
Editor’s Note: This is a great news for those people who are taken multiples pills, now they only need to take one. The only bad thing is the each pill cost about $36 and if you need for 30 days = $1080.00×12 months = $12,960.00. Talk to your insurance and your doctor to get generic and we hope in the coming months the cost will be lowered because the Government will expend less money on ill people who can not afford it and to reduce the risk of infection.