President Barack Obama said Thursday he was comfortable with his administration’s decision to allow over-the-counter purchases of a morning-after pill for anyone 15 and older. (May 2)
The government is moving the morning-after pill over the counter but only those 15 and older can buy it — an attempt to find middle ground just days before a court-imposed deadline to lift all age restrictions on the emergency contraceptive. (April 30)
On Wednesday, June 27, 2012 The U.S. Food and Drug Administration today approved Belviq (lorcaserin hydrochloride), as an addition to a reduced-calorie diet and exercise, for chronic weight management.
The drug is approved for use in adults with a body mass index (BMI) of 30 or greater (obese), or adults with a BMI of 27 or greater (overweight) and who have at least one weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia).
BMI, which measures body fat based on an individual’s weight and height, is used to define the obesity and overweight categories. According to the Centers for Disease Control and Prevention, more than one-third of adults in the United States are obese.
“Obesity threatens the overall well being of patients and is a major public health concern,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The approval of this drug, used responsibly in combination with a healthy diet and lifestyle, provides a treatment option for Americans who are obese or are overweight and have at least one weight-related comorbid condition.”
Belviq works by activating the serotonin 2C receptor in the brain. Activation of this receptor may help a person eat less and feel full after eating smaller amounts of food.
The safety and efficacy of Belviq were evaluated in three randomized, placebo-controlled trials that included nearly 8,000 obese and overweight patients, with and without type 2 diabetes, treated for 52 to 104 weeks. All participants received lifestyle modification that consisted of a reduced calorie diet and exercise counseling. Compared with placebo, treatment with Belviq for up to one year was associated with average weight loss ranging from 3 percent to 3.7 percent.
About 47 percent of patients without type 2 diabetes lost at least 5 percent of their body weight compared with about 23 percent of patients treated with placebo. In people with type 2 diabetes, about 38 percent of patients treated with Belviq and 16 percent treated with placebo lost at least 5 percent of their body weight. Belviq treatment was associated with favorable changes in glycemic control in those with type 2 diabetes. The approved labeling for Belviq recommends that the drug be discontinued in patients who fail to lose 5 percent of their body weight after 12 weeks of treatment, as these patients are unlikely to achieve clinically meaningful weight loss with continued treatment.
Belviq should not be used during pregnancy. Treatment with Belviq may cause serious side effects, including serotonin syndrome, particularly when taken with certain medicines that increase serotonin levels or activate serotonin receptors. These include, but are not limited to, drugs commonly used to treat depression and migraine. Belviq may also cause disturbances in attention or memory.
In 1997, the weight-loss drugs fenfluramine and dexfenfluramine were withdrawn from the market after evidence emerged that they caused heart valve damage. This effect is assumed to be related to activation of the serotonin 2B receptor on heart tissue. When used at the approved dose of 10 milligrams twice a day, Belviq does not appear to activate the serotonin 2B receptor.
Heart valve function was assessed by echocardiography in nearly 8,000 patients in the Belviq development program. There was no statistically significant difference in the development of FDA-defined valve abnormalities between Belviq and placebo-treated patients. Because preliminary data suggest that the number of serotonin 2B receptors may be increased in patients with congestive heart failure, Belviq should be used with caution in patients with this condition. Belviq has not been studied in patients with serious valvular heart disease.
The drug’s manufacturer will be required to conduct six postmarketing studies, including a long-term cardiovascular outcomes trial to assess the effect of Belviq on the risk for major adverse cardiac events such as heart attack and stroke.
The most common side effects of Belviq in non-diabetic patients are headache, dizziness, fatigue, nausea, dry mouth, and constipation, and in diabetic patients are low blood sugar (hypoglycemia), headache, back pain, cough, and fatigue.
Belviq is manufactured by Arena Pharmaceuticals GmbH of Zofingen, Switzerland, and distributed by Eisai Inc. of Woodcliff Lake, N.J.
For more information:
About The U.S. Food and Drug Administration: The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. For more information visit http://www.fda.gov
Photo credit to: U.S. Food and Drug Administration
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.