Ignoring the recommendation of its own advisory committee, the Food and Drug Administration on Tuesday declined to approve the weight-loss drug Contrave, the third such drug the agency has kept off the market in recent months.

The agency concluded that the benefits of the drug — about 50% of patients were able to lose 5% of their body weight in clinical trials, compared with 10% of those receiving placebos — were not sufficient to outweigh the potential risks and the potential for abuse. Many patients receiving the drug had a slight increase in blood pressure and pulse rates.

The FDA notified the drug’s manufacturer, Orexigen Therapeutics Inc. of San Diego, that it would have to conduct a large clinical trial of the drug to test for possible cardiovascular complications in the elderly and the obese before the medication could be marketed, according to a statement released by the company.

Such a trial would probably take three to five years and cost as much as $200 million. Most analysts think such a trial is probably beyond the resources of Orexigen, which is focused solely on the development of anti-obesity drugs and has no other products on the market. The company’s stock fell 73% to close at $2.50 in Nasdaq trading Tuesday after the FDA announcement.

At a December meeting, the FDA advisory panel voted 13 to 7 in favor of approving Contrave, arguing that the potential cardiovascular problems could be addressed in a post-marketing study. If that had been the case, Orexigen’s marketing partner, Japan’s Takeda Pharmaceutical Co., would have shared in the cost of the study.

Contrave is a combination of two drugs already on the market: naltrexone, a drug used to combat alcohol and drug addiction, and bupropion, an antidepressant better known by its brand name Wellbutrin. Market analysts had predicted that, if approved, Contrave could have had yearly sales of $1.2 billion by 2018.

In October, the FDA rejected the proposed weight-loss drug Qnexa because of concerns about heart problems and birth defects. That same month, the agency rejected another experimental diet drug called Lorqess that appeared to cause tumor growth in animals. Also in October, the weight-loss drug Meridia was pulled from the market because of concerns that it boosted the rate of heart attacks and strokes.

Hence is seems like the FDA is exercising more vigilance in the approval of weighloss products, even though they are not considered as medicinal products. To me, that’s good news as it is time to product public safety as these products are too easily available to the public.

Technorati Tags: contrave, diet, fda, orexigen therapeutics

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I have Eczema!

As if things have not gotten more complicated already, now I’ve discovered that the itching I’ve been having for the last 2 years is Eczema.

It started off mild enough….once a month or so, there will be a slight itch that will go away after applying moisturizer for a couple of nights. Then last year, it was a little more sever, as I had gone on vacation in Italy, and the weather was too dry for me. The dry skin persisted on my hands, arms and legs, but it stopped after I applied some steroid cream from my doctor.

However, a few weeks later, the eczema flared up quite badly, such there there was sever itching. Within days, the dry skin had become leathery and red…..

I used steroid creams, despite knowing that it will thin the skin and bones…I was desperate. But it did not work….

steroid creams

I started to moisturize like crazy…….

I tried many different brands of moisturizers

I bought in bulk and stocked up!

After 6 months, spending a small fortune on creams, I stumbled on the eBook which helped me resolve my Eczema in 2 weeks!

Now I realize that Eczema is not a simple case of dry skin…the root cause lies in your immune system, your diet and understanding what you are eating, as well as how your body’s immune system works. Moisturizing your skin works on the dermis (upper skin layer), but not internally. Vitamins A and E are needed in your diet. On hindsight, I realized that I have neglected my health and diet due to my busy schedule. Since I followed the advice in the eBook, I have recoved from Eczema and have never felt healthier!

For Eczema suffers, don’t delay….visit the official website NOW!

You owe it to yourself to an itch-free life.

What Eczema looks like

Technorati Tags: best cure for eczema, best treatments for eczema, diet, eczema cure treatment, eczema cures for adults, eczema cures for children, eczema treatment cure, eczema treatments for adults, health, how to cure psoriasis naturally, natural cures for eczema in adults, new eczema treatment, new treatment for eczema, quickrelief psoriasis and eczema treatment, the best eczema treatment, the best treatment for eczema

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The U.S. Food and Drug Administration today approved the vaccine Gardasil for the prevention of anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people ages 9 through 26 years.

Gardasil is already approved for the same age population for the prevention of cervical, vulvar, and vaginal cancer and the associated precancerous lesions caused by HPV types 6, 11, 16, and 18 in females.  It is also approved for the prevention of genital warts caused by types 6 and 11 in both males and females.

“Treatment for anal cancer is challenging; the use of Gardasil as a method of prevention is important as it may result in fewer diagnoses and the subsequent surgery, radiation or chemotherapy that individuals need to endure,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.

Although anal cancer is uncommon in the general population, the incidence is increasing. HPV is associated with approximately 90 percent of anal cancer. The American Cancer Society estimates that about 5,300 people are diagnosed with anal cancer each year in the United States, with more women diagnosed than men.

Gardasil’s ability to prevent anal cancer and the associated precancerous lesions [anal intraepithelial neoplasia (AIN) grades 1, 2, and 3] caused by anal HPV-16/18 infection  was studied in a randomized, controlled trial of men who self-identified as having sex with men (MSM). This population was studied because it has the highest incidence of anal cancer. At the end of the study period, Gardasil was shown to be 78 percent effective in the prevention of HPV 16- and 18-related AIN.  Because anal cancer is the same disease in both males and females, the effectiveness data was used to support the indication in females as well. 

Gardasil will not prevent the development of anal precancerous lesions associated with HPV infections already present at the time of vaccination.  For all of the indications for use approved by the FDA, Gardasil’s full potential for benefit is obtained by those who are vaccinated prior to becoming infected with the HPV strains contained in the vaccine.

Individuals recommended for anal cancer screening by their health care provider should not discontinue screening after receiving Gardasil.  

As of May 31, 2010, more than 65 million doses of Gardasil had been distributed worldwide, since its approval in 2006 according to the manufacturer, Merck and Co. Inc, of Whitehouse Station, N.J. The most commonly reported adverse events include fainting, pain at the injection site, headache, nausea, and fever. Fainting is common after injections and vaccinations, especially in adolescents. Falls after fainting may sometimes cause serious injuries, such as head injuries. This can be prevented by keeping the vaccinated person seated for up to 15 minutes after vaccination. This observation period is also recommended to watch for severe allergic reactions, which can occur after any immunization.
 

For more information:

Gardasil Product Page

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2010/ucm237941.htm

Technorati Tags: anal cancer, gardisil, health

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The U.S. Food and Drug Administration today approved Halaven (eribulin mesylate) to treat patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease.

Breast cancer is the second leading cause of cancer related death among women, according to the National Cancer Institute. This year, an estimated 207,090 women will be diagnosed with breast cancer, while 39,840 women will die from the disease.

Halaven is a synthetic form of a chemotherapeutically active compound derived from the sea sponge Halichondria okadai. This injectable therapy is a microtubule inhibitor, believed to work by inhibiting cancer cell growth. Before receiving Halaven, patients should have received prior anthracycline- and taxane-based chemotherapy for early or late-stage breast cancer.

Halaven’s safety and effectiveness were established in a single study in 762 women with metastatic breast cancer who had received at least two prior chemotherapy regimens for late-stage disease. Patients were randomly assigned to receive treatment with either Halaven or a different single agent therapy chosen by their oncologist.

The study was designed to measure the length of time from when this treatment started until a patient’s death (overall survival). The median overall survival for patients receiving Halaven was 13.1 months compared with 10.6 months for those who received a single agent therapy.

“There are limited treatment options for women with aggressive forms of late-stage breast cancer who have already received other therapies,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. “Halaven shows a clear survival benefit and is an important new option for women.”

The most common side effects reported by women treated with Halaven include a decrease in infection-fighting white blood cells (neutropenia), anemia, a decrease in the number of white blood cells (leukopenia), hair loss (alopecia), fatigue, nausea, weakness (asthenia), nerve damage (peripheral neuropathy), and constipation.

Other FDA-approved therapies used to treat late-stage, refractory breast cancer include Xeloda (capecitabine) for patients with breast cancer resistant to paclitaxel and anthracycline-containing chemotherapy; Ixempra (ixabepilone) for patients with late-stage disease after failure of an anthracycline, taxane and Xeloda; and Ixempra plus Xeloda for patients with late-stage disease after failure of anthracycline- and taxane-based chemotherapy.

Halaven is marketed by Woodcliff Lakes, N.J. -based Eisai Inc.

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