FDA Information - January 7, 2009

Study Finds More Side Effects in Heart Drug 'Crestor'

May 24, 2005 - Topics study, crestor, asia, impact and fda
A new study may lead to the cholesterol-lowering medication, Crestor, being removed from shelves, as it may have an even greater affect on the kidneys and muscles than previously thought.

The drug is made by AstraZeneca PLC, and in March, the FDA stated that Crestor's risks were no greater than its competitors

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New Diabetes Treatment to Come from Lizards

May 6, 2005 - Topics diabetes, insulin, pharmaceutical, fda and blood
A new diabetes treatment will be based on saliva from a Gila monster, AP reports. The drug, named Byetta, manufactured by Amylin Pharmaceuticals and Eli Lilly & Co., has just cleared FDA testing. Reports say it will hit the market June 1.

According to the makers, "Byetta is a synthetic version of a protein found in the saliva of the Gila monster that works similarly to the human GLP-1

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FDA Approves Drug for Type 2 Diabetics

April 29, 2005 - Topics fda, diabetes, blood, studies and prescription
The Food and Drug Administration annouced its approval of a new drug derived from the saliva of a poisonous lizard called the Gila monster.

Byetta, chemically called exenatide, is the newest option for Type 2 diabetics. The drug is the first of its kind, requires injections twice a day, and presently must be taken along with older diabetes treaments

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Verdict Still Not Out on Alternative Procedure to Liposuction

April 25, 2005 - Topics south america, plant, food, research and blood
A therapy that promises to melt fat away with the help of a syringe has not yet been proven a safe and effective alternative to liposuction, according to a new report. The report, by a committee of the American Society of Plastic Surgeons (ASPS), points to a lack of research data and standardized techniques for the treatment, known as mesotherapy. Mesotherapy breaks down pockets of fat that dwell anywhere from the jaw line to the waistline to the hips. It involves a series of injections into the problem area, with the ingredients of those injections varying from case to case. A mixture of various drugs, plant extracts and other substances may be used. One of the most common ingredients is phosphatidylcholine, or lecithin - a waxy substance found in the cells of plants and animals. Lecithin is added to food and other products as an emulsifier, which means it helps mix fats with liquid. The product may act similarly when used in mesotherapy, emulsifying body fat and allowing natural enzymes to break it down. But whether and how mesotherapy works is still unclear, according to the ASPS report. Other important questions, including the possible effects of the procedure on the liver and other organs, remain unanswered, the authors report in the journal Plastic and Reconstructive Surgery. Mesotherapy is also expensive, with charges as high as $1,500 per treated area and practitioners generally recommend three to six rounds of injections over time. Research is ongoing and has shown slight promise in its results equaling that of current liposuction procedures. The main question mark is whether or not mesotherapy has long-term success. The procedure is called mesotherapy because injections are made into the mesoderm, the layer of fat and connective tissue under the skin. The method was developed by a French physician in the 1950s for the treatment of disorders of the blood vessels and lymphatic system. More recently, it has become a popular non-surgical alternative to liposuction in Europe and South America. Advocates say mesotherapy is far safer than the surgery, which, like all invasive procedures, carries some serious risks-including infection, blood clotting and, rarely, death. A major gap with mesotherapy, however, is the lack of standardization in the formulations and dosages used, and of guidelines stating, for instance, which patients are good candidates. It's also unclear where the body fat ends up after it's purportedly melted by mesotherapy. In the U.S., the individual components used in mesotherapy must be approved by the Food and Drug Administration, but their use in the context of mesotherapy has not been shown safe and effective. And the FDA has never approved a drug specifically for the body-contouring procedure
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FDA Puts Contraceptive Sponge Back in Stores

April 22, 2005 - Topics fda, women, plant, food and safety
The Today Sponge contraceptive, pulled from the market a decade ago, will soon be back in U.S. stores after receiving FDA approval. Friday, the Food and Drug Administration approved U.S. sales of the sponge, which was a popular nonprescription birth control product among women when it was withdrawn from the market in 1995. Now the polyurethane sponges, which manufacturer Allendale Pharmaceuticals has sold in Canada and over the Internet since March 2003, will be available soon in the U.S. through a company Web site. Shortly after that, the product will be available at retail drug chains, followed by supermarkets and mass marketers such as Wal-Mart, Allendale said. Allendale bought rights to sell the Today Sponge several years ago from the prior manufacturer, Wyeth Co. of Madison. Wyeth, then called American Home Products. They stopped making the sponge rather than upgrade its Hammonton manufacturing plant after FDA found deficiencies there, even though the device's effectiveness and safety were never questioned. The Today Sponge, a soft, concave device, prevents pregnancy by covering the cervix and releasing spermicide. Roughly 250 million sponges were sold from 1983 to 1995. While it was less effective than several other methods and does not protect against sexually transmitted diseases, the sponge achieved a wide following among women who saw advantages from spontaneity to wide availability. In Canada, where the original Today Sponge was only on the market about 18 months, more than 400,000 sponges have been sold through retail outlets and Internet sites - without any advertising - since they were approved for sale there two years ago. An advertising campaign for the U.S. market is being developed. Sales are expected to jump from 10 million to 15 million sponges in the first 12 months. That's the current production limit of the company's factory in Norwich, N.Y., but the company has plans to double that
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