Multi-State Recall Of Hard-Cooked Eggs

MINNETONKA, Minn. (CBSMiami) – Michael Foods of Minnesota has issued a recall of hard-cooked eggs due to a possible contamination of listeria. The eggs came in brine sold in 10 and 25 pound pails that are available in 34 states, including Florida. So far, there have been no reports of illness connected to the eggs. The eggs came under the brand names: Columbia Valley Fams, GFS, Glenview Farms, Papetti’s, Silverbrook, and Wholesome Farms. The Food and Drug Administration said the eggs were produced at Michael Foods’ plant in Nebraska and bought by food distributors and manufacturers. According to the Centers for Disease Control and Prevention, listeria primarily impacts older adults, pregnant women, newborns, and those with weakened immune systems. The illness can trigger fever, muscle aches, along with diarrhea or other gastrointestinal problems.

A.M. Vitals: Pfizer Believes Only a Small Number of Birth-Control Pill Packs Are Faulty

Birth-Control Recall: Pfizer has recalled about a million packs of birth-control pills on concerns that incorrect packaging could lead to unplanned pregnancies, but says it believes only 30 packs actually had the troublesome glitches, the WSJ reports . Pfizer has identified three production problems that could permit pills to be placed incorrectly in the packs and go undetected. It’s not clear how many pills have already been used and how many are still in medicine cabinets, the paper says. Regulating Sugar?: A commentary published in Nature calls for sugar added to foods to be regulated, using the taxes and limited availability of tobacco and alcohol as a model, WebMD reports . Commentary author Robert Lustig, of the University of California, San Francisco, says excess sugar is linked to health problems, while the Sugar Association disputes that sugar intake causes disease. The FDA says it is not reconsidering sugar’s current regulatory status as a “generally recognized as safe” product, WebMD reports. Device Pact: Medical-device firms will pay the FDA $595 million over five years under the tentative terms of a new user-fee agreement, the WSJ reports . The FDA will add more full-time employees to consider medical-device applications and will have concrete goals for approval times, the paper says. Surgery Risk Suggested: Research published in Mayo Clinic Proceedings suggests that children who undergo two or more surgeries by the age of two are more likely to develop ADHD in the future compared to children who experience one operation, possibly because of the effects of general anesthesia on the developing brain, Time’s Healthland blog reports . The study cannot prove that anesthesia causes the future problems, however, and a study author says that the benefits of surgery for infants usually outweigh any potential risk, Time says. Image: iStockphoto

FDA (Finally) Gives Amylin’s Bydureon a Thumbs-Up

Bydureon, the once-weekly injection for treating patients with type 2 diabetes, has finally won the FDA’s okay. As Dow Jones Newswires reports , it’s been a long, bumpy road to approval for the drug’s developer, Amylin Pharmaceuticals. (Alkermes is behind the extended-release technology used to deliver the drug, a longer-acting version of Amylin’s twice-daily Byetta.) Amylin started working on the drug in 1999 and first applied for FDA approval — with its then-partner Lilly — a decade later. But the agency in 2010 said it needed more information “about the drug’s prescribing label and the companies’ risk-management plan to ensure the drug’s benefits outweigh its risks,” DJN reports. Later that year, the FDA said the info the companies provided wasn’t enough to approve it, asking for a new study looking at what high doses of the drug might do to heart rhythms. That study showed no problems. As the FDA was weighing the drug, Amylin and Lilly terminated their partnership . The prescribing label for Bydureon will carry a warning about certain thyroid tumors seen in rats who were exposed to the drug, DJN says.

FDA Skeptical of Progesterone Gel For Preterm Delivery

The FDA is casting a skeptical eye on evidence backing a gel being proposed to prevent preterm birth in women with a short cervix. As Dow Jones Newswires reports , one of the agency’s outside advisory panels is due to consider that use of the gel — already approved for certain women undergoing infertility treatments — at a meeting on Friday . A study covering 458 women published last year in the journal Ultrasound in Obstetrics and Gynecology found that the gel cut the risk of early preterm delivery by 45% in women with a short cervix compared to placebo. And because the babies were born closer to their due dates, they saw fewer complications. But background info posted by the FDA on the agency’s website yesterday focused on data for the U.S. women in that study, which was conducted at 44 medical centers in 10 countries. Looking at those U.S. women only, the difference between the progesterone gel and placebo groups could have occurred by chance, the FDA said. “The information and data in this application do not support the efficacy of progesterone gel compared with placebo in reducing the risk of preterm births before 33 completed weeks of gestation among women with a short cervical length,” the FDA said in its background document. The gel is developed by Columbia Laboratories and marketed by Watson Pharmaceuticals. Columbia also posted its own document ahead of the meeting. In it, it said that “the U.S. and non-U.S. regions both favored progesterone, although the size of the treatment effect was greater in the non-U.S. regions.” The data showed a “clinically meaningful reduction in preterm birth and evidence for improvement in infant outcome,” Columbia said. In December, a review published online by the American Journal of Obstetrics and Gynecology encompassing the earlier study and others highlighted the potential of vaginal progesterone — in both gel and suppository form — to prevent preterm birth in women with a short cervix. That condition is a major risk factor for early delivery. Image: iStockphoto

Novartis Issues Recall On Excedrin, Bufferin

WASHINGTON (CBSMiami/AP) — The Food and Drug Administration is warning patients about a potential mix-up between powerful prescription pain drugs and common over-the-counter medications like Excedrin and Gas-X that were made at a Novartis manufacturing plant. The FDA said some of the over-the-counter pills may have accidentally been packaged with the powerful painkillers that were made at the same facility. The agency is not ordering a recall, but the drug maker has issued a voluntary recall that includes Bufferin, Gas-X and the caffeine caplets “No-Doz.” The recall is a result of major manufacturing issues at a Novartis facility in Nebraska, which was shutdown last month after FDA inspectors found problems . The Swiss drug maker decided to pull the products after receiving complaints of mislabeled bottles and broken and chipped pills. The bottles in question are Excedrin and No-Doz with expiration dates of December 20th 2014 or earlier and Bufferin and Gas-Ex with expiration dates of December 20th 2013 or earlier. The FDA said some of the Novartis over the counter pills may also have been packaged with powerful prescription painkillers. Endo Pharmaceuticals sells the drugs as Percocet, Endocet Opana and Zydone but the FDA isn’t recalling those painkillers because the risk of stray pills is low and so many patients rely on those medications . Experts say look at your medications closely and if you have any questions, contact your pharmacist. If you have a recalled product, don’t use it and contact the company for a refund. Novartis said there have been no adverse health events related to the problem and that it’s working on upgrades at its Nebraska plant. (TM and © Copyright 2012 CBS Radio Inc. and its relevant subsidiaries. CBS RADIO and EYE Logo TM and Copyright 2012 CBS Broadcasting Inc. Used under license. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed. The Associated Press contributed to this report.)

A.M. Vitals: FDA Will Restrict Use of Certain Antibiotics in Livestock

Antibiotics in Livestock: The FDA said it will ban the use of antibiotics called cephalosporins to prevent disease in livestock, though the drugs can still be used to treat illnesses in the animals, the WSJ reports . The agency — and other experts — are concerned that over- or misuse of the drugs can create resistant strains of food-borne bacteria that can harm humans. Cephalosporins, however, constitute only a “tiny fraction” of the antibiotics used in livestock, the paper says. Twins on the Rise: One of every 30 babies born in the U.S. is a twin — up from one in 53 in 1980 — reflecting the increased likelihood of multiple births among older moms and the use of assisted reproductive technology, the Associated Press reports . Some experts note that twin pregnancies carry greater risks for both moms and babies than singleton births, the AP says. Testing Possible HIV Vaccines: Research published online by Nature identifies several experimental vaccines that gave monkeys partial protection from a dangerous strain of the simian immonodeficiency virus, which is similar to HIV, the WSJ reports . The lead author of the study tells the paper that plans are underway to test a human-adapted version of one of the vaccines. Getting More Exercise in Daycare: A study published earlier this week in Pediatrics suggests some hurdles to physical activity for kids in pre-school and daycare, namely concerns about injuries, money worries and a focus on academics rather than play and exercise, the Los Angeles Times’ Booster Shots blog reports . Authors of the study said regulations intended to protect kids may actually hinder their activity by limiting play equipment, the LAT says. Image: iStockphoto

A.M. Vitals: FDA and CDC Say Baby Formula Not Contaminated

Infant Formula Test Results: The FDA and CDC said late Friday that tests of factory-sealed Mead Johnson infant formula pulled from some store shelves after a Missouri infant died from a rare infection showed no traces of bacterial contamination, the WSJ reports . The agencies said there was no need for a recall of the formula and that it could continue to be used following the manufacturer’s directions. They added that the bacteria, Cronobacter sakazakii, was found in an opened container of the Enfamil Newborn powder and also in water used to reconstitute the product. Testing to determine the source of the contamination will continue, the paper says. Rethinking a Treatment Regimen: Some researchers are challenging a protocol for treating anorexic patients in the hospital that involves starting out with a low-calorie feeding regimen that often produces weight loss at the beginning of the treatment period, the New York Times reports . Instead they’re pushing for more aggressive feeding; some physicians are saying caution is necessary, however, because feeding patients too many calories at first can cause physical and psychological problems. A Pain in the Neck: A study published in the Annals of Internal Medicine find that spinal manipulation by a physical therapist or chiropractor and a home-exercise regimen both outperformed medication at relieving neck pain, the WSJ reports . After 12 weeks, about 80% of patients in the non-medication groups reported at least a 50% reduction in pain levels vs. about 70% of people assigned to medications such as ibuprofen and muscle relaxants. Activity and Performance: A review of previously published research that appears in the Archives of Pediatrics and Adolescent Medicine offers some evidence that participation in sports or physical activity may be associated with better academic performance, the Los Angeles Times’ Booster Shots blog reports . Still, the authors of the review said that future research needed to objectively measure how much activity study participants were getting, and to quantify how much activity is necessary to produce a school-performance benefit. Image: iStockphoto

A.M. Vitals: Panel Wants Clearer Language on Some Birth-Control Pills

Weighing the Risks: An outside FDA advisory panel is recommending clearer language covering the potential risks of blood clots on the labels of some birth-control pills, though a majority of panel members said the benefits of the pills outweigh the risks, the WSJ reports . Studies attempting to figure out whether Bayer AG’s Yaz, Yasmin, Beyaz and Safyral as well as generic versions pose a higher risk of blood clots than other oral contraceptives have produced conflicting results. The FDA often, but not always, follows the advice of its outside committees. Report Finds No Health Harm: HHS’s Agency for Toxic Substances and Disease Registry says bombing exercises on the island of Vieques, in Puerto Rico, didn’t harm residents’ health, the New York Times reports . The review follows an earlier report, which also found no link between compounds and metals produced by years of Navy bombing and health problems of Vieques residents, the paper says. Unpleasant Discovery: An inspection at drug manufacturer Ben Venue Laboratories’ Ohio plant turned up quality and sterility lapses including a container suspected to hold urine, the WSJ reports . Ben Venue is a supplier of Johnson & Johnson’s cancer drug Doxil, and problems at the company have caused supply disruptions to that and other drugs, the paper says. New Guidelines for Latent TB: The CDC is recommending a new drug regimen for treating latent tuberculosis that shortens treatment time to three months from nine, HealthDay reports . The new guidelines apply only to people in the U.S. who carry the TB bacteria but don’t have symptoms and aren’t infectious. CDC Director Thomas Friedan calls them a “game changer,” HealthDay says. Image: iStockphoto

A.M. Vitals: Drugs Help Women With Metastatic Breast Cancer in Studies

Drugs for Late-Stage Breast Cancer: Research presented at the San Antonio Breast Cancer Symposium and published online by the New England Journal of Medicine shows that adding two drugs to standard therapy for metastatic breast cancer can halt tumor growth for several months, the WSJ reports . One study found that adding Roche’s pertuzumab to Herceptin and chemotherapy stopped tumor growth for an additional 6.1 months in patients with HER2-positive breast cancer, while a separate study of Novartis’s Afinitor found the drug stopped tumor growth for an additional 4.2 months when added to another drug, a form of hormone therapy. Experts said it’s too soon to know if the drugs will actually improve survival. Paving the Way For Health Apps: General Electric and Microsoft plan to announce a health IT venture today to create a platform for developing software applications for health-care providers that address quality and cost, the New York Times’s Bits blog reports . The new company, which aims to have about 750 employees and will be located near Microsoft headquarters in Washington state, will include existing products from the two companies including Microsoft’s Amalga and G.E.’s Qualibria software, Bits says. Unanimous Recommendation: An outside FDA advisory panel unanimously recommended the agency approve Pfizer’s drug axitinib to treat advanced kidney cancer after research showed it halted tumor growth for two months longer than an existing drug, the WSJ reports . The drug hasn’t been shown to improve survival. Norovirus Vaccine?: A small study of an experimental vaccine against norovirus, which causes diarrhea and vomiting, showed the vaccine outperformed a placebo, WebMD reports . Results from the 90-person analysis were published in the New England Journal of Medicine . Researchers say more studies are needed to answer questions such as how long the vaccine’s benefits will last and whether it will protect against multiple strains of the virus, WebMD says. Correction: An earlier version of this post didn’t make clear that pertuzumab stopped tumor growth for an additional 6.1 months and that Afinitor stopped tumor growth for an additional 4.2 months. Image: iStockphoto

A.M. Vitals: Obama Directs $50 Million to U.S. HIV Patients

Call for Funding: President Obama called for spending an extra $50 million on U.S. HIV/AIDS programs, including $15 million for HIV clinics and $35 million for state drug-assistance programs, the WSJ reports . He also called for putting about 2.1 million more people globally on antiretroviral drugs by the end of fiscal 2013, through the U.S. program known as Pepfar. He spoke at a World AIDS Day event in Washington, D.C. Development Guidelines: The FDA issued guidelines for companies and researchers working to develop an artificial pancreas to treat type 1 diabetes, Reuters reports . Advocates are generally optimistic that the guidelines will encourage innovation, Reuters says. Doesn’t Reproduce: The results of most medical studies, even those that appear in well-respected, peer-reviewed journals, can’t be reproduced by other scientists, the WSJ reports . The current issue of the journal Science is focusing on the problem, which may spring in part from the increased complexity of today’s experiments and variations in equipment or materials researchers use. Calls for Recusal: Conservatives are calling for Justice Elena Kagan to recuse herself in the upcoming Supreme Court case on the constitutionality of the health-care overhaul law because she used to be President Obama’s solicitor general, while those on the left want Justice Clarence Thomas to sit out the case because of his wife’s ties to groups that have advocated against the law, the Los Angeles Times reports . But the paper notes that Supreme Court justices “pride themselves on their impartiality and rarely recuse themselves unless they have a direct financial stake in the outcome of a case.” Image: iStockphoto