Surgeons at UC Irvine Medical Center are the first in the country to use a device that reduces by half the need to reoperate and cut out breast cancer cells missed during an initial lumpectomy. The MarginProbe System lets the surgeon immediately assess whether cancer cells remain on the margins of excised tissue. Currently, patients have to wait days for a pathologist to determine this…
The top-selling class of blood-pressure drugs is under attack from an unusual source: a senior regulator at the Food and Drug Administration. Bucking his bosses, Thomas A. Marciniak is seeking stronger warnings about the drugs known as angiotensin receptor blockers, or ARBs, according to internal documents reviewed by The Wall Street Journal. The drugs, which are taken by millions of people and generated $7.6 billion in U.S. sales in 2012, may be linked to higher cancer rates, Dr. Marciniak argues, a view shared by some outside doctors. Top FDA officials say evidence doesn't support a link. The debate over ARBs highlights the question of whether the U.S. drug-safety agency devotes enough effort to examining the safety of long-marketed blockbusters as it focuses on new drugs. In a rare rebellion by an FDA reviewer, Dr. Marciniak has clashed with his bosses over his desire to spend time on ARB safety, instead of just on new-drug applications. Ellis Unger, chief of the drug-evaluation division that includes Dr. Marciniak, called the complaints a “diversion,” and said in an interview, “We have no reason to tell the public anything new.” ARBs on the market in the U.S. include Novartis AG's Diovan, Daiichi Sankyo Co.'s Benicar, Merck & Co.'s Cozaar, Boehringer Ingelheim GmbH's Micardis; Avapro, from Sanofi SA and Bristol-Myers Squibb Co.; and AstraZeneca PLC's Atacand. Patients take these medicines daily to avoid heart attack, stroke and heart failure. In a 2010 study published in Lancet Oncology, Ilke Sipahi and colleagues at University Hospitals in Cleveland looked at five studies involving 68,402 patients and found that people taking ARBs had an 11 percent greater risk of new cancer overall and a 25 percent greater risk of new lung cancer, compared with patients who didn't get the drugs. But within a year, the FDA gave the all-clear signal, saying its own analysis found “no increase in risk” from taking ARBs. Europe's drug regulator also dismissed the cancer concerns. Dr. Marciniak wasn't persuaded. In its analysis, the FDA combined different studies to look at more patients, multiplying its statistical power to find possible side effects from the drugs, a technique called meta-analysis. If the original studies have flaws, however, meta-analyses can simply compound the problem, researchers say. That is what happened to the FDA, says Dr. Marciniak, who warned others in the agency that taking results tabulated by companies was likely to produce unreliable results: “Garbage in, garbage out,” he wrote. Among other things, Dr. Marciniak said in an internal analysis viewed by the Journal that the FDA meta-analysis didn't count cases of “lung carcinomas” as lung cancers, which they are. Click for more from The Wall Street Journal.source : http://www.foxnews.com/health/2013/05/31/dispute-flares-within-fda-over-safety-popular-blood-pressure-drugs/
Allergy medications may help you get through the spring and summer months, but it's important to know that the drugs could affect your ability to drive, the Food and Drug Administration is reminding consumers. These medications, which contain antihistamines, can sometimes cause drowsiness and slower reaction times, the FDA said. Consumers should read the drug facts label on their medication to see whether drowsiness is a side effect. If an allergy medication causes drowsiness, people need to be cautious about deciding to drive or operate machinery, the FDA says. People should avoid using alcohol, sedatives (sleep medications) and tranquilizers when taking allergy medication because these substances may increase drowsiness. [See Will Allergies Be Worse in 2013?] Those who switch to a new antihistamine drug should not assume they can take the same dose as they did with the older drug, the FDA says. Different allergy medications may be dosed differently, and people may need to alter the dose they take. People should not take more than the recommended dose. If the correct dosage isnt providing you the relief you expect, dont simply keep taking more and more of that product, FDA pharmacist Ayana Rowley said in a statement. Instead, people should consult a health care professional, Rowley said. Allergy sufferers should be aware that some allergy medications take longer to work than others. In addition, the drowsiness you feel after taking the medication may last some time, including into the next day, the FDA said. Copyright 2013 LiveScience, a TechMediaNetwork company. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.source : http://www.foxnews.com/health/2013/05/29/allergy-meds-can-pose-driving-hazard-fda-says/
The eastern New Mexico peanut butter plant shuttered eight months ago after a salmonella outbreak is back in production, and company officials say their coveted natural and organic butters could be back on store shelves within a month. Sunland Inc. Vice President Katalin Coburn says the company last week got the go-ahead from the Food and Drug Administration to restart peanut butter operations at its factory in Portales. It is currently in a test phase of production, she said. “The restart of the plant is not as simple as turning on a switch,” Coburn said Thursday. “Hopefully we will be back in full production in the next few days.” The Food and Drug Administration shut the plant in late September after its products were linked to 41 cases in 20 states. Most of those were linked to natural peanut butter the company made for Trader Joe's. The shutdown of the country's largest organic peanut butter processor left many stores scrambling for months to find alternative natural peanut butters. The company processes Valencia peanuts, a sweet variety of peanut that is unique to the region and preferred for natural butters because it is flavorful without additives. It makes peanut butter under a number of different labels for retailers like Costco, Kroger and Trader Joe's. It also makes nut butter products under its own name. When the FDA shuttered the plant, it was the first time it used new authority granted under a 2011 food safety law to shut food operations without a court hearing. Many in the conservative farm town of Portales denounced the FDA's tactics as unfair and unnecessarily heavy-handed. Coburn said consumers and retail partners alike have been supportive throughout the shutdown. “Obviously they were as frustrated as we were with the length of time,” she said. “They were saying, `We want Valencia. We want you guys. We want organic. So hurry up.'”source : http://www.foxnews.com/health/2013/05/24/shuttered-new-mexico-plant-resumes-making-peanut-butter/
"Many researchers have been working on such a diagnostic test for a long time — for me, it has been 20 years," says lead investigator Massimo Raimondo, M.D., a gastroenterologist at Mayo Clinic in Florida. "But for the first time, we have found a very strong candidate molecular marker. "We all want a foolproof method to detect pancreatic cancer in our patients so that we can deliver appropriate therapy, as soon as possible," Dr. …
The Food and Drug Administration has approved Johnson & Johnson's drug Simponi for patients with moderate to severe ulcerative colitis, an inflammatory disease affecting the colon. Simponi is already approved to treat rheumatoid arthritis. Like RA, ulcerative colitis is an auto-immune disease in which the body's immune system attacks its own organs. In the case of ulcerative colitis, inflammation can lead to open sores or ulcers in the lining of the colon, causing stomach pain, gastrointestinal bleeding and diarrhea. The most common side effects of Simponi in clinical trials of patients with ulcerative colitis were upper respiratory infection and redness at the site in which the drug is injected. Patients treated with Simponi, known also as golimumab, are at increased risk of developing serious infections, reactivation of Hepatitis B infection, heart failure and certain nervous system disorders. The drug is marketed by J&J's Janssen Ortho Biotech unit.source : http://www.foxnews.com/health/2013/05/16/fda-approves-new-drug-to-treat-ulcerative-colitis/
The Food and Drug Administration approved label changes incorporating lower dosages for sleep medications containing zolpidem, a drug that can continue to affect patients' mental alertness even a day after its use. The regulator approved changes to the labels of Sanofi SA's Ambien, Ambien CR and Meda AB's Edluar on Tuesday. The agency said patients who take zolpidem extended-release drugs, such as Ambien CR, should not drive or take part in activities that require complete mental alertness the next day. The FDA in January asked zolpidem manufacturers, including NovaDel Pharma Inc and Swedish drugmaker Meda, to reduce recommended dosages on the drugs' labels. The regulator also said that women were more susceptible to the risk as they eliminated the drug from the blood more slowly than men. The FDA recommended doses of 5 mg for women and either 5 mg or 10 mg for men for immediate-release zolpidem products such as Sanofi's Ambien. The initial dose of extended-release products is 6.25 mg for women and either 6.25 or 12.5 mg for men, according to the FDA.source : http://www.foxnews.com/health/2013/05/14/fda-approves-labels-with-lower-doses-for-sleep-drugs-like-ambien/
Maybe you’ve heard that going supermarket shopping while hungry can cause you to spend more money. But, did you know that researchers at Cornell University found that hungry grocery shoppers are more apt to slip high-calorie foods into their cart? You can keep your food bill and your waistline in check simply by eating something before heading out to the grocery store. Grabbing a quick snack is probably easier on the weekend than it is after work when you are tired and your stomach is growling.  Choosing sugary candy and cookies from the office vending machine isn’t very diet-friendly nor will these hold you for long. Your best bet is to plan ahead and have a healthy, satisfying grab-and-go snack at the ready.  Here are some simple and tasty ideas: String cheese and grapes This refreshing sweet and salty combo could not be easier to pack. You can count on the natural sugar in the grapes to give you a nice energy boost while the protein in the cheese will digest slowly, keeping hunger in check until you sit down to dinner. Hummus and veggies Talk about smart substitutes! Let some baby carrots or sliced peppers answer the call for something crunchy, and by pairing them with hummus you have a light yet savory alternative to a bag of fatty deep-fried chips. Apple slices with peanut butter Simply cut an apple in half and core it. Then fill each cavity with a spoonful of creamy peanut butter. You get the fruity-nutty taste of a PB&J sandwich without the bread, plus a lot more tummy-filling fiber and protein.   Gorp!   This acronym stands for “good old raisins and peanuts,” but with some creative license it covers a healthy trail mix, too. Prepare a batch in minutes by mixing some dried fruit, almonds, high fiber cereal, and whole wheat pretzel sticks. Then fill zip-lock baggies with 1/2 cup portions.   Strawberries and Cream Start with a single serving of Greek yogurt and top it with juicy ripe sliced strawberries.  Greek yogurt is creamier than traditional yogurt and much higher in protein, which keeps you feeling full longer. The berries provide natural sweetness and tang and feel free to add a drizzle of sugar-free chocolate sauce over the strawberries to make this healthy snack seem more like a decadent dessert. For more tips, delicious high fiber meal plans, recipes, and proven ways to lose weight and look great, check out my new book The Miracle Carb Diet: Make Calories and Fat Disappear – with Fiber! Tanya Zuckerbrot MS, RD, is a registered dietitian in New York City and the bestselling author of The Miracle Carb Diet: Make Calories and Fat Disappear – with fiber, and The F-Factor Diet: Discover the Secret to Permanent Weight Loss.  Follow Tanya on Facebook, Twitter and LinkedIn, and visit her website Ffactor.com  source : http://www.foxnews.com/health/2013/05/14/snack-before-shop/