Tag Archives: safety

Drugmakers to cooperate in safety review of diabetes drugs

Global drugmakers said on Wednesday they would cooperate with an independent review to address concerns of a potential link between widely used diabetes medicines and pancreatic cancer and other safety problems. The American Diabetes Association (ADA) this week called for a new evaluation of clinical data on drugs used to control blood sugar for patients with type 2 diabetes. They include Merck & Co's $4 billion a year Januvia franchise, Novo Nordisk's Victoza, and Byetta and Onglyza from Bristol-Myers Squibb Co and AstraZeneca Plc, among others. “People who are taking these medications, or who may consider taking them, should have the benefit of all that is currently known about their risks and advantages in order to make the best possible decisions about their treatment,” Dr. Robert Ratner, ADA's chief scientific and medical officer, said in a statement. The medicines are called incretin mimetics because they mimic hormones the body produces to stimulate release of insulin, and are from classes of drugs known as GLP-1 receptor agonists and DPP-4 inhibitors. GLP-1 drugs boost insulin production by the pancreas and slow absorption of food. DPP-4 inhibitors block an enzyme the breaks down the GLP-1 peptide in the gut, thereby increasing insulin production. The U.S. Food and Drug Administration in March said it was studying unconfirmed reports that the drugs cause inflammation of the pancreas and pre-cancerous changes to cells in the pancreas. European health regulators are also studying the issue. Around the same time, new concerns arose from a small study conducted by a leading diabetes expert, Dr. Peter Butler, from the University of California, Los Angeles. Butler examined human pancreases from patients who had died of causes unrelated to pancreatic disease and found more pancreas lesions and one cancerous tumor in those who had taken Januvia or Byetta compared with nondiabetics or diabetics who had not taken those medicines. More than 370 million people are living with diabetes worldwide, with type 2 accounting for 90 percent to 95 percent of the cases, according to the International Diabetes Federation. Without significant lifestyle changes to curb obesity and other causes of diabetes, that number could balloon to as many as 552 million by 2030, the organization projected. NO FIRM EVIDENCE OF RISK Bristol-Myers and AstraZeneca issued a joint statement expressing support for the ADA initiative. Merck said it is committed to participating in the ADA effort, and is separately conducting a 14,000-patient heart safety study of Januvia. Danish drugmaker Novo Nordisk, in an emailed comment, said its studies to assess safety signals of its $1.8 billion a year Victoza do not reveal any evidence of increased risk of pancreatitis or pancreatic cancer. “As far as the ADA proposal is concerned, this is something that I do support from a conceptual basis,” said Alan Moses, Novo's global chief medical officer, in a telephone interview. “In principle, Novo Nordisk absolutely supports working with the other companies, but the final details depend on what specifically is being proposed,” Moses said, adding “it all depends on the credibility of the data that's being evaluated.” The safety concerns are being discussed on Wednesday and Thursday at a workshop conducted by the National Institutes of Health (NIH) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). A document outlining the FDA's presentation at the workshop was handed out at the meeting. Attendees quoted it as saying the agency review of trial data on the drugs did not provide enough evidence to say whether there is a link to pancreatitis, and that long-term study would be required to determine any cancer risk. A FDA spokeswoman could not immediately confirm the contents of the document. “The FDA basically appears to just be saying 'look, there just isn't enough information here to make an informed decision',” said Mark Schoenebaum, a drug industry analyst with ISI Group who was attending to two-day NIH/NIDDK workshop. “There are no conclusions at this point in time from the meeting and I doubt very much there will be because the science quite frankly is immature about the whole area of pancreatic cancer,” said Novo's Moses, who will address the workshop on Thursday. “Everybody agrees that this is an incredibly complex area.” In an interview with Reuters earlier this week Peter Stein, Merck vice president of clinical research for diabetes, expressed full confidence in the safety of Januvia. During the workshop, Merck said it will present data on the safety profile of Januvia, known chemically as sitagliptin, including an updated analysis of data from more than 14,000 patients from 25 randomized clinical trials. Merck last month reported a surprising decline in first quarter sales of Januvia, which has been the drugmaker's fastest growing medicine since its 2006 approval. It was not clear if increased competition, safety concerns or other factors led to the 4 percent slip in quarterly sales to $884 million.source : http://www.foxnews.com/health/2013/06/13/drugmakers-to-cooperate-in-safety-review-diabetes-drugs/

Energy drinks no better than caffeine, study suggests

Despite the “special blend” of ingredients, energy drinks work no better than ordinary caffeine at helping us pay attention, a new study suggests. In the study, researchers examined participants' brain activity while they performed a task designed to require attention. Specifically, the researchers looked at how fast the brain responded to a change in letters appearing on a computer screen. Before the task, participants consumed 8 ounces of either water, water with caffeine, or water containing the energy drink 5-Hour Energy. The caffeinated drinks were adjusted so that they had the same amount of caffeine per pound of participants' body weight, and all drinks were colored blue. During the task, participants who drank the caffeinated drinks had faster brain responses, compared with those who drank plain water. But there was no difference in brain activity between those who consumed caffeinated water, and those who consumed 5-Hour Energy. More from LiveScience “A lot of people take the energy drinks because they think they have that extra boost over caffeine,” said study researcher Chelsea Benham, a student at Centre College in Danville, Ky. But the study shows “there's really no difference,” Benham said. In terms of boosting attention, a cup of coffee “would do you just as well,” if it had the same amount of caffeine as an energy drink, she said. A 2-ounce bottle of 5-Hour Energy contains about 215 milligrams of caffeine, the equivalent of about two cups of coffee. An advantage of 5-Hour Energy is that it contains a concentrated amount of caffeine — people need to consume a larger volume of coffee to get the same amount of caffeine. However, there has been concern over the safety of energy drinks in general because of their ability to deliver high doses of caffeine in such a concentrated form. Last year, the FDA said it had received reports of health problems linked with 5-Hour Energy, including heart attacks and death, although the reports do not prove that the energy drink was the cause of these problems. Some health experts have been concerned about the combination of compounds in energy drinks, and are calling for more research to determine what amount is safe to consume. Energy drinks can contain chemicals such as guarana, taurine, L-carnitine, ginseng and yohimbine. In the new study, researchers also did not find a difference in participants' physical reaction times (on a test that involved clicking a computer mouse when a particular letter appeared on a screen), regardless of whether they consumed a caffeinated or non- caffeinated drink. Benham said this may have been because the test took only 20 minutes. Over a longer period, she said she suspects there would be a difference. The study was presented at the annual meeting of the Association for Psychological Science in Washington, D.C., on May 26. Benham conducted the work with her adviser, KatieAnn Skogsberg, an assistant professor of psychology and behavioral neuroscience at Centre College. 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/2013/06/05/energy-drinks-no-better-than-caffeine-study-suggests/

Quit-smoking treatments safe, effective, review says

Popular smoking cessation treatments - such as nicotine replacements and antidepressants - improve people's chances of kicking the habit without much risk, according to a review of past research. “It seems very clear that medications can help. They're not the magic bullet but you do improve your chances of quitting - generally - if you try them. And as far as we can tell, they're safe to use,” said Kate Cahill, who led the study. Several reviews have looked at the effectiveness of smoking cessation treatments, but the researchers wanted to put those results into a single large review to help people who want to use medical treatments to stop smoking, Cahill, a senior researcher for the Cochrane Tobacco Addiction Group at the University of Oxford, UK, said. About one fifth of the U.S. and UK populations are current smokers, according to the researchers. Previous studies have found between 70 percent and 75 percent want to quit, but only about 3 percent accomplish that every year. For the new study, the researchers pulled data from 12 reviews published by the Cochrane Collaboration, an international research organization that evaluates medical evidence. Those analyses, which were conducted between 2008 and 2012, included data from 267 studies of more than 101,000 smokers. The studies typically compared smokers trying to quit without the help of a smoking cessation treatment to smokers using nicotine replacement therapies, such as nicotine gum and patches, or prescription drugs. The medications include varenicline (marketed by Pfizer as Chantix or Champix) and bupropion (marketed by GlaxoSmithKline as Zyban or Wellbutrin, but available as a generic). The researchers found that the nicotine replacement therapies and the antidepressant bupropion led about eighteen people to successfully give up smoking for every 10 people who quit without treatments. Varenicline performed even better and led to about 28 people quitting for every 10 who did so without medication. What's more, Cahill and her colleagues found that lesser-known smoking cessation treatments were also effective. Those include the antidepressant nortriptyline and cytisine, a plant-derived supplement available in Eastern Europe. All of the treatments also appeared to be reasonably safe, according to the researchers who published their results on Thursday in The Cochrane Library. Previous reports have found that about 1 in every 1,000 people taking bupropion has a seizure, but the researchers found a lower rate of 1 in 1,500. Also, despite conflicting reports over the safety of varenicline, the researchers didn't find evidence that the drug increased the risk of neuropsychiatric or heart problems. Judith Prochaska, who researches tobacco treatment but was not involved in the new study, said not all smokers will use smoking cessation tools but it's important for them to know they're available. Nicotine replacement therapy is available over the counter in the U.S. and varenicline and bupropion are available with a prescription for about $4 per day - less than a pack of cigarettes, said Prochaska, associate professor of medicine at the Stanford Prevention Research Center in California. “They have been shown to pretty much double the likelihood that somebody will quit,” she added. Cahill cautioned, however, that smoking cessation tools won't work for everyone, but “they certainly help some people.”source : http://www.foxnews.com/health/2013/05/31/quit-smoking-treatments-safe-effective-review-says/

Foster Farms recalls grilled chicken breast strips for containing allergens

SAN FRANCISCO – & California-based chicken producer Foster Farms is recalling about 6,165 pounds of its ready-to-eat grilled chicken breast strips because the strips contain wheat and soy -- known allergens -- which are not listed on the labels of its packages, federal agriculture officials said. The mislabeled packages were discovered when a customer complained, the U.S. Department of Agriculture's Food Safety and Inspection Service said in announcing the recall Tuesday. The problem occurred when labels for another chicken product that does not contain wheat or soy were inadvertently used, food safety inspectors and officials at Foster Farms said. There have been no reports of adverse reactions from the sale of the mislabeled products, officials said. The chicken breast strips being recalled were sold in 4.5-pound cases containing 12, 6-ounce trays of “Foster Farms Grilled Chicken Breast Strips Boneless & Skinless With Rib Meat 97% Fat Free,” with an identifying case code of “000606.” The recalled product bears the establishment number “P-20923” inside the USDA mark of inspection and a use-by date of “JUN 22 2013” printed on each tray. They were produced April 23 and were distributed to retailers in Arizona, California, Hawaii, Nevada, Oregon, Utah and Washington. Based in Porterville, Foster Farms is a family-owned company that has been operating since 1939, according to the company's website. In a statement, Fosters Farms spokeswoman Lorna Bush said “food safety is, and always has been, our top priority.”source : http://www.foxnews.com/health/2013/05/22/foster-farms-recalls-grilled-chicken-breast-strips-for-containing-allergens/