Thursday, March 1, 2012

News and Events - 02 Mar 2012




29.02.2012 22:34:00


Photo courtesy of Flickr user
Mr. T in DC.

Grab some chocolate, pop an aspirin and wash it all down with red wine. You're on your way to a heart-healthy life, right? Not so fast.

According to Dr. Steven Nissen, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, much of the information Americans use as a guide for heart health is little more than folklore.

"It's appalling," he said. "And it's getting worse. These days, you can conduct an Internet search for any heart condition and get a lot of information. The problem is most of it is wrong. And a lot of the common mythology is wrong, too."

In a new book, "
Heart 411," Nissen and his colleague, cardiac surgeon Dr. Marc Gillinov, approach some of the more popular rumors "the way a jury would approach a trial": Is there evidence beyond a reasonable doubt that red wine is good for your heart or that red meat is bad?

On this final day of American Heart Month, Nissen shared some of their verdicts.

Myth 1: Red Wine

"It turns out that there's no information to suggest that red wine is better than any other form of alcohol for your heart," Nissen said. "But there is information to show that moderate alcohol intake of any kind -- red wine, white wine, beer or hard spirits -- benefits patients in preventing heart disease. It does so by raising the good cholesterol, or HDL.

"The myth about red wine came from the so-called French paradox -- that the French drink a lot of red wine and they have a relatively low instance of heart disease, despite the fact that they eat a lot of fat. People began to think maybe red wine was protecting them. And there was a little bit of research in animals showing that an element of red wine known as resveratrol seemed to be protective in mice. But what the public didn't get was that they gave thousands of times more resveratrol to the mice than humans would ever get from drinking red wine, and the research just didn't hold up in additional studies.

"At the end of the day, we don't recommend taking up drinking to benefit your heart. But if you do drink a glass or two of alcohol per day, depending on your body mass, it can be a heart-healthy activity."

Myth 2: Red Meat

"Red meat is a source of saturated fat, and all other things being equal, saturated fat does tend to raise the bad cholesterol, LDL. And so it's not a good thing," Nissen said.

"However, we stress the importance of a diet we call, 'no-fad.' One of the most disturbing current trends promises that if you eat no meat and virtually no fat, you'll become 'heart attack proof.' Our conclusions from the research out there is that this is just utter nonsense -- that there are no 'heart-attack-proof' diets, that completely eliminating fat, including meat, does not have a convincing health benefit, and that in fact a balanced diet is best.

"We advocate what is called the Mediterranean diet -- one that actually has quite a bit of fat -- good fat like olive oil and canola oil, fats that contain polyunsaturated fatty acids and not a lot of trans fats. If someone promises you that a diet will melt away the plaque in your coronary, run as fast away from those diets as you can.

"Eating red meat in moderation is not a problem. It's not good for your heart, but if you don't exceed reasonable quantities -- small amounts of red meat as part of a balanced diet -- it is not something people need to avoid."

Myth 3: Chocolate

"There is a little bit of evidence -- and it's not very strong -- that dark chocolate is probably an OK food for the heart," Nissen said. "There's even a small study that seems to indicate that dark chocolate might lower blood pressure a little bit. But the effects are very small, and all chocolate tends to have a fair amount of calories and a lot of sugar.

"And so to call any chocolate a heart-healthy food is a mistake. This is another example, because it's cutesy, because it's newsy: Whenever one of these poor-quality studies comes out, they get latched upon by the media. But the truth is there are no randomized control trials of any quality on this subject.

"In our book, we talk about the difference between an observational study and a randomized control trial. Most of the alcohol and chocolate studies do not come from randomized control trials, where you would give half the people these substances for five years and half of them would avoid it altogether and you find out who does better. In fact, they come from observational studies, which are inherently flawed. And so the solidity of the evidence is much more limited when you have only observational data."

Myth 4: Work-Related Stress

"It's not a huge factor, but it does appear to play some role in a minority of heart attacks," Nissen said. "We actually have some pretty good scientific data that extreme levels of stress can cause something called
Broken Heart Syndrome, which is caused by a sudden rush of stress.

"The best data comes from some interesting observations that during the Super Bowl, when a person is rooting for his or her team and their stress and anxiety goes up, there appears to be more heart attacks. But even better data comes from places like Israel, during the first Gulf War (and the Scud missile attacks. When people were under tremendous stress, there was a big bump in the rate of heart attacks.

"All of this shows that stress under some circumstances, particularly when it's extreme, can trigger a heart attack. But it is also important to note that we are pretty well-adapted as a species to handle stress. Our ancestors had lots of it. When we were swinging from the trees in the jungle, there were predators chasing after us. And so stress is not just a function of modern life. We don't think chronic stress is good for people. It does seem to raise levels of inflammation in the body. But people should not believe that if they've got some stress in their lives, it's going to make them have a heart attack. Stress is a factor, but it's certainly not the most important factor in heart disease."

Myth 5: Sex

"It's extremely rare, but you can have a heart attack from sex," Nissen said. "There is some data -- and this is perhaps comforting to some spouses in the country -- that sex with your regular partner does not raise the heart rate and blood pressure to levels that are strongly associated with having a heart attack.

"However, sex with a non-regular partner, particularly if you're in an extramarital relationship, does seem to have an association with an increased risk of a heart attack. And I think the reasons that most people have surmised is that there is more excitement involved. There may be a fear of being caught and there's maybe some guilt. For all of those reasons, heart rate and blood pressure go up and may act as a trigger for a heart attack.

"So it's one more reason to stay faithful to your spouse. On the opposite end of the spectrum, don't count on sex as your form of exercise for the day. For most of us, the duration of activity is insufficient to meet the aerobic needs of an exercise program."

Updated March 1: Here is the second set of myths as explained by Nissen:

Myth 6: Dietary Supplements

"Almost all of our patients come in taking dietary supplements, and they believe that it will help their heart health because it says right on the bottle, 'Promotes heart health.' These are products like fish oil, coenzyme Q, and the big rage now, Vitamin D. You know, if you go into the local pharmacy, you can find row after row after row of dietary supplements -- many I haven't even heard of. And none of these claims have been evaluated by the Food and Drug Administration.

"In fact, in a great national tragedy in 1993, Congress passed a law that barred the FDA from regulating dietary supplements. And so we don't even know whether most of the dietary supplements actually contain the ingredients they claim to contain. At the moment, everybody is taking Vitamin D, and there just isn't evidence that it protects the heart. More importantly, it diverts patients away from the real therapies that they need.

"Often when we go on a book signing, we will ask the audience how many people take fish oil. And lots of hands go up. And then we ask them, 'Do you think the fish oil lowers your cholesterol?' and most of the hands go up. Fish oil actually raises levels of LDL cholesterol -- it doesn't lower it, it raises it. But the problem is those claims cannot be regulated because the FDA is virtually powerless. Sooner or later there will be a major national catastrophe.

"We also warn people that these dietary supplements can even interact with their prescription medications, causing them to become toxic or ineffective. And so there are no dietary supplements that we recommend for patients."

Myth 7: An Aspirin a Day

"Another long-standing myth is that it's a good idea to take an aspirin a day for people who are at risk for heart disease. In fact, if you're at low enough risk -- if you're an otherwise healthy 40- or 50-year-old man or woman -- it actually increases your risk of adverse consequences, including bleeding into your brain and into your stomach. That's because aspirin is an anticoagulant, it prevents clotting of the blood. And that is, of course, a benefit but it's also a risk.

"In the stomach, it has been found to irritate the lining by affecting something known as the prostaglandins, which are protective in the stomach. When those prostaglandins are altered, the stomach is more vulnerable to the effects of acid, leading to erosion of the stomach and bleeding. And the second mechanism is that because aspirin is an anti-platelet agent, it actually prevents blood clotting. And so the combination of irritation to the gastro-intestinal tract plus the anti-coagulant effect is what leads to an increased risk of gastrointestinal bleeding, which is quite significant.

"As for the brain, people of certain ages have areas of weakness in the blood vessels of the brain, and if you get a little bit of a break in those blood vessels and your blood clots normally, nothing bad may happen. But if you have an anticoagulant on board, you may have a serious cranial bleed. When you add it all up, for people who are otherwise healthy, the risks exceed the benefits of taking an aspirin a day."

Myth 8: Stress Testing

"This is an often-unnecessary test in which a patient walks on a treadmill and has their electrocardiogram monitored so that the physician can look for changes that may be a consequence of not getting enough blood flow to the heart muscle. It's a test that's very commonly done in America millions of times each year, and many people are having them done who shouldn't. In fact, we strongly discourage it in most cases unless the patient is having chest pain symptoms.

"The problem with it is that there are too many false positives and no evidence that screening people with stress testing actually improves their health. These tests often lead to an angiogram and ultimately, to unnecessary coronary interventions, like a stent. Why is this being done so much? Well I hate to be so cynical, but one of the reasons is that are certainly economic incentives for doctors to over-test. Some people have the test done simply because they tell their doctor they want to start an exercise program and their doctor will say, 'OK, well let's do a stress test on you.' People should push back against those kinds of recommendations if they don't have any of the symptoms of heart disease."

Myth 9: Calcium Testing

"This is another test commonly performed and widely advocated that we don't recommend. People are put in a special kind of CT scan and their doctor looks for calcium in the coronaries of the heart. When you see calcium, it usually means there's plaque in the coronaries, and physicians can then try to prevent heart disease. The problem is that we should be preventing people with risk factors whether or not they have calcium in their coronaries. And so essentially it doesn't give us information that we can use productively to prevent people from dying or having a heart attack.

"Even though it may have some predictive value, it also can lead to more testing and some pretty significantly bad consequences. If a minor blockage is found, the temptation is often very high to do an angiography, to do a catheterization, and sometimes, even to put in a stent. There's no evidence that if you take somebody who doesn't have symptoms and do a heart catheterization, that anything you find will actually benefit the patient. And so it's driving up health care costs. America spends more on health care than any other country by a factor of about two, and this is one of the reasons why."

Myth 10: Women Don't Feel Chest Pain During Heart Attacks

"This one is just pervasive. After a recent article in JAMA (the Journal of the American Medical Association , this has been covered by the media a lot -- that many women who have heart attacks don't have chest pain. While that may be true for some women, it's important to understand that the principal symptom of a heart attack in both men and women is chest pain. About 12 percent of women are more likely not to have chest pain during a heart attack, but that's not a huge difference.

"Women may just have a shortness of breath or dizziness or pass out, but the same is true for a small percentage of men. Men and women are more alike than dissimilar. There are some differences, but they're not as big as people may think. For heart attacks, the same advices should be given to both genders: If you have chest pain, if you have a sudden onset of severe shortness of breath, if you get dizzy, light-headed and sweaty all of a sudden, take it seriously, call 911 and get to the hospital -- whether you're a man or a woman."






2012-02-28 11:03:43
A new study finds that people who take certain commonly prescribed sleeping pills have a five-fold increased risk of death, even among those taking fewer than 18 doses a year. And these drugs are also linked to a significantly increased risk of cancer among those taking high doses, the study, published in the journal BMJ Open, shows. The study, analyzing 10,500 people who took a wide-range of sleeping pills including zolpidem, diazepam and tamazepam, found that the top third of sleeping pill users had a 5.3-fold higher death risk and also had a 35 percent higher risk of cancer. And people who were on higher doses of tamazepam were six times as likely to die in the next 30 months, the study found. “We are not certain. But it looks like sleeping pills could be as risky as smoking cigarettes. It looks much more dangerous to take these pills than to treat insomnia another way,” study leader Daniel F. Kripke, MD, told WebMD. The sleeping pills in question are known as hypnotics and include such brands as Ambien and Restoril. Hypnotic sleeping pills actually cause a person to fall asleep. This is in contrast to other sleeping aids, such as melatonin, which promote sleep through relaxation. Kripke and colleagues said other dangerous hypnotic sleeping aids include Lunesta, Sonata, Halcion, and Dalmane. Kripke, retired professor of psychiatry at the University of California, San Diego, began studying the effects sleeping pills have on the risk of death in 1975. Since then, he has co-published 18 studies finding links between the two. In the latest study, Kripke and colleagues analyzed data from a large Pennsylvania health system from between 2002 and 2007. They obtained medical records for 10,529 people who used prescribed hypnotic sleeping pills and for 23,676 matched patients who were never prescribed sleeping pills. Over an average of 2.5 years, the death rate for those who did not use sleeping pills was 1.2 percent. For those who were prescribed sleeping pills the death rate climbed to 6.1 percent. And after taking into account factors likely to influence the results - including age, sex, weight, lifestyle, ethnicity and previously diagnosed cancer - the study’s results pointed to a 3.6-fold higher death rate in those who only took 18 or fewer doses. Based on their findings, Kripke and colleagues estimate that sleeping pills are linked to between 320,000 and 507,000 US deaths each year. “We think these sleeping pills are very dangerous. We think they cause death. We think they cause cancers,” said Kripke. “It is possible but not proven that reducing the use of these pills would lower the U.S. death rate.” The associations of increased death risk was found in every age group, but were greatest among those aged 18 to 55. Supplemental material published alongside the paper showed that, although the overall numbers of deaths in each group were quite small, there were clear differences among them. For example, there were 265 deaths among 4,336 people taking zolpidem, compared with 295 deaths among the 23,671 people who had not taken sedatives or sleeping pills. Kripke pointed out that studies showing association do not necessarily prove cause and effect, however. But the findings do back up previous research showing an increased risk of death among sleeping pill users, he added. “The meager benefits of hypnotics [sleeping pills], as critically reviewed by groups without financial interest, would not justify substantial risks,” wrote Kripke. “A consensus is developing that cognitive-behavioral therapy of chronic insomnia may be more successful than hypnotics.” Sleeping pills are thought to also increase risk of depression and can impair driving skills. Kripke has passed the study findings on to the US Food and Drug Administration (FDA , the watchdog to the US pharmaceutical industry. The authors of the study said their findings, together with similar findings in previous studies, should be used by authorities to re-assess whether even modest doses of sleeping pills are safe. “Although the authors have not been able to prove that sleeping pills cause premature death, their analyses have ruled out a wide range of other possible causative factors,” wrote Dr Trish Groves, editor in chief of BMJ Open. “So these findings raise important concerns and questions about the safety of sedatives and sleeping pills.” National Health Service (NHS guidelines recommend zolpidem should only be used at the lowest possible dose and for a maximum of up to four weeks. Zaleplon should only be used at the lowest possible dose and for a maximum of up to two weeks, while temazepam should be taken for a maximum of four weeks. Most of those in Kripke’s study were taking Ambien or Restoril. Sanofi-Aventis, the maker of Ambien, noted that Kripke’s study had a number of faults. “Ambien has more than 17 years of real-world experience and is safe and effective when prescribed and taken according to its labeling,” Sanofi told WebMD in a statement. “Ambien should be prescribed in strict adherence to its labeling and patients should take their medication as prescribed. The Ambien labeling carries specific warnings against driving and against intake of alcohol together with Ambien.” And although experts note the Kripke study certainly raises concerns, they said it does not prove that sleeping pills kill. This “very provocative and interesting study raises a lot of questions,” Nancy Collop, MD, president of the American Academy of Sleep Medicine and director of the Sleep Center at Emory University School of Medicine, told WebMD. “You cannot assume, just because you find this kind of association, that hypnotics are killing people,” she said. “People who go on sleeping pills are a sicker population. I know they tried to control for that, but these people simply are not as healthy.” Michael Yurcheshen, MD, head of the sleep fellowship program and assistant professor of neurology at the University of Rochester, NY, noted that much can be missed in a study that looks back at medical records rather than at the patients themselves. “It is implausible to think that so many of these medications, spread across several different drug classes, could have the same biological effects,” Yurcheshen told WebMD. Yet, both Collop and Yurcheshen praise Kripke for raising the issue of sleeping pill dangers. “One part of the Kripke study I really did like is when they point out that part of the problem with hypnotics is they are really best for people with acute, short episodes of insomnia,” Yurcheshen said. “Very few insomnia drugs are approved for long-term daily use. And so it is fair to say that the long-term safety of these drugs has never been explored for use in that way.” Collop said she is torn on the issue of whether hypnotics are “good or bad.” She noted that it can be harmful to be dependent on hypnotic sleeping pills for a long period of time. But they can be very helpful to those who are having great difficulty in falling asleep for some specific reason. She noted that sleeping pills are mainly short-term use aids. “So the ideal patient would be someone with a very high stress level for some reason, such as the recent loss of loved one or a divorce, or for a traveler adjusting to a new time zone. This should be for a limited time period and only as needed, not on a nightly basis. In such situations these drugs are appropriate and effective,” she told WebMD. Kripke, colleagues and the experts all agree that a form of short-term psychotherapy -- cognitive behavioral therapy -- is surprisingly effective for people with chronic insomnia. Collop says it’s time to see a sleep specialist if you have tried sleeping pills and they don’t work anymore. Looking for another brand of sleeping pill will not work. Nina Barnett, spokesperson for the Royal Pharmaceutical Society told The Telegraph: “This is an important study and although it is unlikely to radically change prescribing in the immediate term, it should raise awareness and remind both patients and prescribers to the potential risks of sedative use for insomnia.” “The association between mortality and sedation is not new and this research tells us is that people who took these medicines were more likely to die than people who didn’t take them. However it does not mean that the deaths were caused by the medicine,” she added. “Patients should not stop taking any prescribed medicines straight away. If you are concerned about your medicines discuss this with your pharmacist or Doctor about other ways of getting help with sleep problems so you don’t have to use medicines.” --- On the Net:



NHS Choices
29.02.2012 21:00:00

Patients with a common type of metal hip implant should have annual health checks for as long as they have the implant, according to the UK body for regulating medical devices. The all-metal devices have been found to wear down at an accelerated rate in some patients, potentially causing damage and deterioration in the bone and tissue around the hip. There are also concerns that they could leak traces of metal into the bloodstream, which the annual medical checks will monitor.

Hours before critical coverage from the British Medical Journal and the BBC, the Medicines and Healthcare products Regulatory Agency (MHRA issued new guidelines on larger forms of ‘metal-on-metal’ (MoM hip implants. Advice on smaller metal devices or those featuring a plastic or ceramic head has not changed. Previously, guidelines suggested larger MoM implants should only be checked annually for five years after surgery. The agency now says the annual check-ups should be continued for the life of the implant. Check-ups, they say, are a precautionary measure to reduce the “small risk” of complications and the need for further surgery.

Together with the recent controversy over PIP breast implants, the news has caused some medical quarters to call for tighter regulation of medical devices, perhaps bringing the approval process into line with that of medicines, which must undergo several years of laboratory, animal and human testing before being approved for wider use.

What types of implants are involved?

There are numerous designs and materials used to make hip implants. In recent days the MHRA has issued major updates to its advice on a type of metal-on-metal (MoM hip replacement. As the name implies, MoM implants feature a joint made of two metal surfaces – a metal ‘ball’ that replaces the ball found at the top of the thigh bone (femur and a metal ‘cup’ that acts like the socket found in the pelvis.

The MHRA’s updated advice concerns the type of MoM implant in which the head of the femur is 36mm or greater. This is often referred to as a ‘large head’ implant. The agency now says that patients fitted with this type of implant should be monitored annually for the life of the implant, and that they should also have tests to measure levels of metal particles (ions in their blood. Patients with these implants who have symptoms should also have MRI or ultrasound scans, and patients without symptoms should have a scan if their blood levels of metal ions are rising. The previous guidance on this type of hip implant, issued in April 2010, advised that patients should be monitored annually for no fewer than five years.

What about other types of hip implants?

Advice on monitoring patients with other types of hip implants remains the same, and guidance has not changed on:

  • MoM hip resurfacing implants – where the socket and ball of the hip bone has a metal surface applied to it rather than being totally replaced.
  • Total MoM implants where the replacement ball is less than 36mm wide.
  • A particular range of hip replacements called DePuy ASR – these hip replacements were recalled by their manufacturer, DePuy, in 2010 because of high failure rates. The company made three types of ASR implant.
  • Implants featuring plastic or ceramic heads.

How many people are affected?

It is estimated that, in total, 49,000 people in the UK have been given metal-on-metal implants with a width of 36mm or above. This represents a minority of the patients given hip replacements, who mostly have devices featuring plastic, ceramics or smaller metal heads.

In 2010 there were 68,907 new hip replacements fitted, and approximately 1,300 of these surgeries used an MoM implant sized 36mm or above – a rate of around 2%.

What exactly is the problem with MoM implants?

All hip implants will wear down over time as the ball and cup slide against each other during walking and running. Although many people live the rest of their lives without needing their implant to be replaced, any implant may eventually need surgery to remove or replace its components. Surgery to remove or replace part of the implant is known as ‘revision’ and, of the 76,759 procedures performed in 2010, some 7,852 were revision surgeries.

However, data now suggest that large head MoM hip implants (those with a width of 36mm or greater wear down at a faster rate than other types of implants. As friction acts upon their surfaces it can cause tiny metal particles (medically referred to as ‘debris’ to break off and enter the space around the implant. Individuals are thought to react differently to the presence of these metal particles, but, in some people, they can trigger inflammation and discomfort in the area around the implant. Over time this can cause damage and deterioration in the bone and tissue surrounding the implant and joint. This, in turn, may cause the implant to become loose and cause painful symptoms, meaning that further surgery is required.

News coverage has also focused on the MHRA’s recommendation to check for the presence of metal ions in the bloodstream, potentially released either from debris or the implant itself. Ions are electrically charged molecules. Levels of ions in the bloodstream, particularly of the cobalt and chromium used in the surface of the implants, may, therefore, indicate how much wear there is to the artificial hip.

There has been no definitive link between ions from MoM implants and illness, although there has been a small number of cases in which high levels of metal ions in the bloodstream have been associated with symptoms or illnesses elsewhere in the body, including effects on the heart, nervous system and thyroid gland.

The MHRA points out that most patients with MoM implants have well functioning hips and are thought to be at low risk of developing serious problems. However, a small number of patients with these hip implants develop soft tissue reactions to the debris associated with some MoM implants.

How are medical devices regulated?

In the UK, the MHRA is the government agency responsible for ensuring that medical devices work and are safe. The MHRA audits the performance of private sector organisations (called notified bodies that assess and approve medical devices. Once a product is on the market and in use, the MHRA has a system for receiving reports of problems with these products, and will issue warnings if these problems are confirmed through their investigations. It also inspects companies that manufacture products to ensure they comply with regulations.

This system differs greatly from that for testing and approving drugs. Drugs require several years of research testing and trials before they can be approved for clinical use.

What action have regulators taken?

The MHRA has convened an expert advisory group to look at the problems associated with MoM implants. This meets regularly to assess new scientific evidence and reports from doctors and medical staff treating patients. The agency says it is continuing to monitor closely all the latest evidence about these devices and may issue further advice in the future.

In the US, the Food and Drug Administration (FDA says it is gathering additional information about adverse events in patients with MoM implants. In the meantime, it advises patients with MoM hip implants who have no symptoms to attend follow-up appointments as normal with their surgeon. Patients who develop symptoms should see their surgeon promptly for further evaluation.

What actions have critics called for?

In light of the PIP breast implant controversy and this new information on hip implants, there is currently intense scrutiny on the way medical devices are regulated in the UK and Europe, with patient groups and the media arguing that medical devices should be regulated in a similar way to medicines.

Clearing a medicine for use in the UK is a lengthy process involving several stages of laboratory and animal testing, and then carefully controlled and monitored tests in humans. Only once there is enough evidence to suggest that a medicine is reasonably safe can it enter clinical use, and even then patients will be monitored to look at the longer-term effects of the drug.

However, medical devices are not required to go through human trials before entering use, and can currently be approved on the basis of mechanical tests and animal research. While certain devices, such as hip implants, have been monitored through systems such as the National Joint Registry, in light of the recent health concerns over PIP breast implants, patient groups are calling for more testing before devices are allowed into clinical use, and closer mandatory monitoring schemes to ensure their safety once they enter the market.

Links To The Headlines

Annual blood tests for hip patients over poison fears. The Daily Telegraph, February 29 2012

Hip replacement toxic risk could affect 50,000. The Independent, February 29 2012

MHRA: Metal hip implant patients need life-long checks. BBC News, February 29 2012

Metal scare over hip replacement joints. The Guardian, February 29 2012

Toxic metal hip implants 'could affect thousands more people than PIP breast scandal. Daily Mail, February 29 2012




2012-02-29 06:16:38
The U.S. Food and Drug Administration (FDA announced on Tuesday that they would be adding memory loss and diabetes warnings to the labels of cholesterol-lowering drugs known as statins. According to Reuters reporters Bill Berkrot and Ransdell Pierson, the label changes come after the agency learned of studies in which taking statins could lead to a small increased risk of cognitive issues such as memory loss or confusion, as well as a slight spike in blood sugar levels and the risk of developing type 2 diabetes. FDA spokesperson Erica Jefferson told Reuters that the changes were "part of our ongoing surveillance." The affected products include Lipitor (atorvastatin , Lescol (fluvastatin , Mevacor (lovastatin , Altoprev (lovastatin extended-release , Livalo (pitavastatin , Pravachol (pravastatin , Crestor (rosuvastatin , and Zocor (simvastatin . Combination products include: Advicor (lovastatin/niacin extended-release , Simcor (simvastatin/niacin extended-release , and Vytorin (simvastatin/ezetimibe , the FDA said in a statement reprinted by Tuesday. When asked about the changes, Cleveland Clinic Cardiology Chairman Steven Nissen told Forbes reporter Matthew Herper that the blood sugar warning is the result of "a very small uptick in blood sugar that makes a few more people cross the threshold we call diabetes." “This small increased risk of higher blood-sugar levels needs to be taken in the context of the very strong evidence of beneficial things that are provided by statins,” added Matthew Price, director of the cardiac catheterization laboratory at Scripps Clinic in La Jolla, California, in a telephone interview with Bloomberg's Anna Edney and Michelle Fay Cortez. “This doesn’t affect my prescribing of statins where it’s clinically indicated, though I will make sure I closely follow patients at risk for diabetes.” In terms of the cognitive issues, the FDA said that reports of memory loss and/or confusion were not series, and in most cases the symptoms were reversed after the patient stopped using the statin. The agency also noted that they would be removing a requirement for regular monitoring of liver enzymes for those using the cholesterol medication, after concluding that serious liver injury was "rare and unpredictable in individual patients, and that routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing this rare side effect." They did, however, warn patients to contact their doctors if they experienced any symptoms of liver-related ailments, including weakness or fatigue, loss of appetite, dark-hued urine, yellowing of the skin or the whites of the eyes, or upper abdominal pain. “We want health-care professionals and patients to have the most-current information on the risks of statins, but also to assure them that these medications continue to provide an important health benefit of lowering cholesterol,” Mary Parks, director of FDA’s division of metabolism and endocrinology products, told Edney and Cortez. --- On the Net:



01.03.2012 6:44:40



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About 80% of all antibiotics sold in the United States are for livestock production

Tell the FDA to stop the overuse of antibiotics in industrial agriculture!

February 29, 2012

If I get sick or injured, I want to know that the antibiotics that I need to take are going to work. Unfortunately, with all the antibiotics that industrial agriculture feeds to livestock, today's antibiotics are at risk of becoming ineffective. Take action today to keep antibiotics working in the future!

According to the U.S. Food & Drug Administration (FDA , 80 percent of antibiotics in the U.S. are sold for use in livestock production. Often, antibiotics are fed to entire flocks or herds of animals to prevent illnesses they may never acquire or have little risk of contracting. The overuse of antibiotics encourages the development of antibiotic-resistant bacteria. This is a global threat to human health and must be stopped.

Bacteria, like everything else in nature, mutate naturally and do so in such a way to continue their own existence. Not all bacteria are destroyed by antibiotics, and the surviving bacteria then multiply, creating a new strain that the antibiotics cannot kill. We're seeing more and more types of antibiotic-resistant bacteria , but we can help stop this.

The FDA is seeking comments on the use of one specific type of antibiotic in livestock. The deadline for comments is Tuesday. Will you submit a comment today?

Send an email to the FDA today to stop the overuse of antibiotics:

http://action.foodandwaterwatch.org/p/dia/action/public/?action_KEY=9495



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2012-03-01 10:10:56
US District Judge Richard Leon sided with tobacco companies on Wednesday, ruling that regulations requiring large graphic health warnings on cigarette packaging and advertising violate free speech rights under the US Constitution, reports Wendy Koch for USA Today. Leon continued, writing that the requirement would “violate the First Amendment by unconstitutionally compelling speech.” The decision conflicts with a January 2010 ruling by US District Court Judge Joseph McKinley, that upheld the labels’ legality and is expected to end up at the steps of the US Supreme Court for a final decision. In 2009, Congress gave authority to the Food and Drug Administration (FDA to regulate tobacco and approved nine graphic warnings that tobacco makers could rotate on cigarette packs beginning in September. The tobacco products images would include prominent images of rotting teeth, diseased lungs and a corpse with chest staples on an autopsy table. The images, which would cover the top half of the front and back of each pack. In the 19-page ruling, Judge Leon argued that, while educating the public about the dangers of smoking, “might be compelling, an interest in simply advocating that the public not purchase a legal product is not.” Further, Leon said the government has numerous other tools at its disposal to deter smoking such as raising cigarette taxes or including simple factual information on the labels rather than gruesome images, Jeremy Pelofsky reported for Reuters. Matthew Myers of the Campaign for Tobacco-Free Kids said Leon’s ruling that the “graphic images are neither factual nor accurate” is “incomprehensible,” arguing that smoking causes fatal lung disease, cancer and heart disease. Reynolds American Inc’s R.J. Reynolds unit, Lorillard Inc, Liggett Group, Commonwealth Brands, which is owned by Britain’s Imperial Tobacco Group, and Santa Fe Natural Tobacco challenged the rule, arguing it would force them to engage in anti-smoking advocacy against their own legal products. “We believe governments, public health officials, tobacco manufacturers and others share a responsibility to provide tobacco consumers with accurate information about the various health risks associated with smoking,” said Martin Holton, general counsel for R.J. Reynolds. “However, the goal of informing the public about the risks of tobacco use can and should be accomplished consistent with the US Constitution,” Holton added in a company statement. --- On the Net:



01.03.2012 18:16:43
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: FDA Approves Four-Strain Flu Vaccine A new nasal-spray flu vaccine approved by the U.S. Food and Drug Administration protects against four...



01.03.2012 0:02:51
WAYNE, N.J, Feb. 29, 2012 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA has approved a lower dose formulation of Angeliq (drospirenone and estradiol tablets to...



29.02.2012 23:00:00
Federal health officials have added new safety alerts to statins, a class of drugs used to lower cholesterol levels. The Food and Drug Administration cited rare side effects, including memory loss, diabetes and muscle pain. Robert Siegel talks to Rob Stein about the news.



29.02.2012 16:02:13
From UPI Health News (Business (February 28, 2012 The U.S. Food and Drug Administration approved safety label changes for statins -- a class of cholesterol-lowering drugs known as statins, officials said. Statins, along with diet and exercise,...



29.02.2012 4:00:00
A recent announcement released by the Food and Drug Administration (FDA , claims that statins, drugs taken to lower cholesterol, may cause various health problems. According to IMS Health, over 20 million Americans were taking some type of statins last year...



jandrews@foodsafetynews.com (James Andrews
29.02.2012 12:59:03
Aiming to help foster safer growing practices for sprout producers, the U.S. Food and Drug Administration announced on Tuesday it would form a one-year partnership and grant $100,000 to the Illinois Institute of Technology's Institute for Food Safety and Health (IFSH to coordinate the
Sprout Safety Alliance (SSA .
The SSA, a public-private organization, will develop outreach programs and training for the sprout industry to prepare growers for upcoming sprout safety regulatory requirements. Sprout-growing operations are subject to unique safety precautions, such as testing spent irrigation water and seed disinfection. 
The organization plans to develop safety training materials for sprout growers, provide tools to allow growers to conduct self-audits of their facilities, and ensure that growers understand the inherent risks associated with sprouts, which have been linked to at least 
44 foodborne illness outbreaks in North America since 1990. The SSA will also serve as a hub for sprout industry resources by providing technical assistance to growers and networking them with buyers, retailers and regulatory agencies.
The FDA's announcement comes within months of three prominent sandwich restaurant chains choosing to remove sprouts from their menus due to a mounting number of foodborne illness outbreaks linked to the food. 
Most recently, Jimmy John's decided to stop serving sprouts after the Centers for Disease Control and Prevention announced on February 15 that the restaurant's sprouts were linked to an E. coli O26 outbreak that has sickened 14 people in six states. It was the fifth outbreak tied to Jimmy John's sprouts in four years.
Earlier this year, Jason's Deli and Erbert & Gerbert's restaurants also dropped sprouts, each citing food safety concerns. Back in October 2010, Walmart stopped selling sprouts in its stores. The warm, wet environments needed to grow sprouts are also conducive to bacterial growth, making sprouts especially susceptible to carrying pathogens.
The IFSH, part of the Illinois Institute of Technology, is an applied research institute that focuses on designing practical approaches to challenges in the food industry.




01.03.2012 19:17:00
FDA has updated questions and answers about the safe use of approved pancreatic enzyme products.



01.03.2012 9:50:04
Federal health officials are adding new alerts to statins about the rare risks of memory loss, increased blood sugar levels and muscle pain.



28.02.2012 21:41:22
The FDA said Merck failed to meet a requirement to conduct a safety study in rodents of its blockbuster diabetes drug Januvia.



29.02.2012 1:20:07
AP - Federal health officials are adding new safety warnings about risks of memory loss and elevated blood sugar to statins, the most widely prescribed group of cholesterol-lowering medications.



01.03.2012 20:43:49
U.S. regulators delayed a decision on a proposed new anticlotting drug from Bristol-Myers Squib and Pfizer by three months to June 28, after the companies provided new information to the agency.



29.02.2012 8:01:00
Federal health officials on Tuesday added new safety alerts to the prescribing information for statins, cholesterol-reducing medications that are among the most widely prescribed drugs in the world, citing rare risks of memory loss, diabetes and muscle pain.



29.02.2012 7:48:58
The FDA warned that patients taking cholesterol-fighting statins face a small increase in the risk of higher blood-sugar levels and of being diagnosed with diabetes.

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