The FDA said Chantix and Zyban will carry the warnings to alert consumers to the risks of depression and suicidal thoughts when using the drugs.

The drugs also have been reported to cause changes in behavior, hostility and agitation in users, whether users had a history of psychiatric illness or not. In many cases, side effects started shortly after use began and ended when the medication was stopped. The FDA does not know what is causing the changes and said people taking these products should be monitored by their doctor.

“The risk of serious adverse events while taking these products must be weighed against the significant health benefits of quitting smoking,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “Smoking is the leading cause of preventable disease, disability and death in the United States, and we know these products are effective aids in helping people quit.”

The agency also is requiring Pfizer Inc., which makes Chantix, and GlaxoSmithKline, maker of Zyban, to conduct a study looking at how often these serious symptoms occur.

Pfizer says it updated its label in 2007 to include information of neuropsychiatric symptoms and has revised the label again to reflect Wednesday’s warning.

“The labeling update underscores the important role of health care providers in treating smokers attempting to quit and provides specific information about Chantix and instructions that physicians and patients should follow closely,” said Dr. Briggs W. Morrison, senior vice president of the primary care development group at Pfizer. “Quitting smoking is one of the best things people can do for their health, but the quitting process is both difficult and complex.”

The FDA says that since Chantix was approved in 2006, the agency has had reports of 98 suicides and 188 attempted suicides. Zyban has had reports of 14 suicides and 17 attempts.

Zyban contains the same active ingredient as the antidepressant Wellbutrin and already carried a box warning about the increased risk of suicidal thinking and behavior.

Neither Chantix nor Zyban contains nicotine, and the FDA said some symptoms could be the result of nicotine withdrawal. Still, the agency said, people using these drugs experienced some of these symptoms while they were still smoking.

In a review of side effects in patients using the nicotine patch, the agency said it didn’t find a clear link between those products and suicidal events.

Two anti-smoking drugs to carry mental-health warnings

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The woman had been living in a long-term care facility, a spokesman for the Minnesota Department of Health said on Saturday.

Her name and date of death were not released. It was the third death tied to salmonella in Minnesota.

The spokesman said he did not know if the woman had eaten peanut butter. Several products containing peanut butter have been recalled as the U.S. government investigates the outbreak of salmonella food poisoning.

On Wednesday, federal officials said the sole source of the U.S. salmonella outbreak involving contaminated peanut butter appears to be the Peanut Corp of America’s Blakely, Georgia, processing facility.

The company produces peanut butter for use in nursing homes and cafeterias, as well as a concentrated product used in many commercially produced products, including cakes, cookies, crackers, candies, cereal and ice cream.

More than 125 products including cookies, crackers, ice cream and even some pet foods have been recalled in connection with the outbreak, the U.S. Food and Drug Administration said.

As of Wednesday evening, 491 people had been reported infected by a salmonella outbreak by public health authorities in 43 of the 50 U.S. states, the Centers for Disease Control and Prevention said on its website.

Salmonella can cause abdominal cramping, diarrhea and fever and it can kill the very young and very old.

Salmonella death in Minnesota brings U.S. total to 7 | U.S. | Reuters

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The Centers for Disease Control and Prevention has linked the salmonella outbreak to products made with peanut paste and peanut butter manufactured after July 1 in a Georgia factory owned by Peanut Corp. of America. The company, which is based in Virginia, supplies peanut butter and paste to long-term-care and other institutions, food service companies and private-label manufacturers that use the products in cookies, cakes, crackers and other foods. None of the company’s peanut products are sold directly to consumers. It has paused all production in its Georgia facility.

It is unclear how the peanut products were contaminated with salmonella, which is carried by animal feces. Foods can also become contaminated by infected food handlers who do not wash their hands with soap after using the bathroom.

Several of the nation’s largest retailers and manufacturers are voluntarily recalling products that may contain the contaminated peanut butter or paste. Among the retailers are Safeway, Kroger and Meijer, and products include Famous Amos Peanut Butter Cookies, Keebler Cheese & Peanut Butter Sandwich Crackers and Little Debbie Peanut Butter Toasty crackers. A list of recalled products is being kept and updated by the government at http://www.accessdata.fda.gov/scripts/peanutbutterrecall.

The salmonella outbreak follows a string of food safety scares in recent years that has shaken consumer confidence and raised alarms about whether the federal government is adequately protecting the nation’s food supply. The Grocery Manufacturers Association, which represents food manufacturers and retailers, has asked the Obama administration to significantly increase funding for federal food safety programs in the hope that a robust inspection program will reduce contamination outbreaks and restore consumer confidence.

“Food safety and consumer safety is absolutely paramount for us,” said Mike Gloekler, a spokesman for McKee Foods, which manufactures Little Debbie products. Gloekler said the recall affected about 7,000 cases of peanut butter crackers, a small fraction of the company’s 100-product line.

Kris Charles, a spokeswoman for Kellogg, said yesterday that the FDA confirmed that salmonella was found in a package of its Austin Quality Foods Toasty Crackers with Peanut Butter. The company has recalled that and 15 other products that are made with peanut paste or butter from Peanut Corp. of America. She said about 7 million cases of Kellogg products were affected, and they represented less than 1 percent of the company’s product line.

Major-label peanut butter is not suspected to be contaminated with salmonella and is considered safe to eat, according to the U.S. Food and Drug Administration. Several major brands, including Peter Pan, Jif and Smuckers, are worried that panicky consumers will stop buying their products and have been taking pains in recent days to point out that their peanut butters are not part of the outbreak.

Salmonella bacteria can cause an infection known as salmonellosis, which often produces diarrhea, fever, and abdominal cramps 12 to 72 hours after infection. The illness usually lasts four to seven days. While most people recover without treatment, infants, elderly people and those with compromised immune systems can develop severe illness that can result in death if not promptly treated with antibiotics.

The CDC has linked salmonellosis in peanut products to the illnesses of 485 people between Sept. 8 and Jan. 2. The victims ranged in age from less than 1 year to 98 years old. About 23 percent of those with the infection were hospitalized, and six died. Federal officials say the illness count may increase because it takes two to three weeks after a person becomes ill for the sickness to be reported.

U.S. Broadens List of Peanut Products to Avoid Eating – washingtonpost.com

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Rinsing with mouthwash containing alcohol makes it easier for cancer-causing substances like nicotine to penetrate the lining of the mouth, says the report’s author, Professor Michael McCullough.

More than 3,000 people were examined for the research, giving ’sufficient evidence’ that using mouthwash is linked to the development of oral cancer.

The study, published in the Dental Journal of Australia, said some mouthwashes contain a higher alcohol content than drinks bought in pubs and bars.

It is suggested that dentists should only prescribe mouthwashes containing high levels of alcohol for short-term use.

Oral cancer is a big killer in the UK.

In 2006, it caused 1,700 deaths and almost 5,000 people are diagnosed with the disease each year.

Yinka Ebo, from Cancer Research UK, said: “Alcohol definitely causes mouth cancer.

“The idea that alcoholic mouthwashes could increase the risk of mouth cancer makes sense – but more research is needed.”

But Prof Damien Walmsley, from the British Medical Association, cautions that the evidence linking alcoholic mouthwash and oral cancer “is not conclusive”.

Anyone with concerns about using mouthwash is advised to contact their dentist.

Mouthwash Containing Alcohol May Increase The Risk Of Getting Oral Cancer, Says A Study | World News | Sky News

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The numbers, from 2007, show that cases of chlamydia as well as syphilis rose for the third year in a row, according to a report by the U.S. Centers for Disease Control and Prevention (CDC).

“The bad news from last year has continued,” said Dr. John M. Douglas Jr., director of the CDC’s Division of STD Prevention. “These infections remain at very high levels, and frankly, unacceptably high.”

Chlamydia and gonorrhea, the two most commonly reported infectious diseases in the United States, together accounted for almost 1.5 million reported cases of sexually transmitted disease (STD) in 2007.

“Chlamydia is at a new all-time record 1.1 million cases — it went up about 7 percent since 2006,” Douglas said. “Gonorrhea is about at 355,000 cases.”

STDs, although easily diagnosed and treated, frequently occur without symptoms and may go untreated. Left untreated, chlamydia and gonorrhea can result in pelvic inflammatory disease — a condition that causes as many as 50,000 U.S. women to become infertile each year, according to the report, Sexually Transmitted Disease Surveillance, 2007.

The overall rate of chlamydia infections among women was 543.6 cases per 100,000 females, almost three times the rate among men — 190 cases per 100,000 males, the report said.

The increasing number of chlamydia cases is actually a reflection of more people being screened, not a greater incidence of the disease in the population, Douglas said. “It’s kind of a mixed piece of good news. We wish those numbers were going down, but we know they have to go up before they go down,” he said.

Gonorrhea rates have been stable for about the last 10 years, Douglas said. “This is stable at quite a high level. It represents an example where we have a job half done. Gonorrhea has come down since its highpoint in the 1970s, but we just got stuck in the late 1990s, and we’ve been stuck ever since then,” he said.

Rates of gonorrhea were also higher among women — 123.5 per 100,000 women — compared with 113.7 per 100,000 men, according to the report.

But these numbers are probably just the tip of the iceberg, Douglas noted. The CDC estimates that only half of all new chlamydia and gonorrhea infections are reported, bringing the actual number of infected people to more than 3 million.

“We think there are really 2 to 2.5 million cases of chlamydia a year,” he said.

The report also found continued increases in rates of syphilis. On the verge of elimination just a decade ago, syphilis rates began increasing in 2001 and rose 15.2 percent between 2006 and 2007, Douglas said.

“We got set back in a recurrence of syphilis among men who have sex with men,” Douglas said. “There has been limited success in trying to curb that, but we have begun to see a slide in some of the better-controlled populations.”

The increases in syphilis in 2007 were predominately among women. “We have seen increases in babies, which is the ultimate innocent bystander population,” Douglas said.

What’s more, if you have syphilis, you also have a 50 percent chance of being HIV-positive, he added.

The report found continued racial disparities for STD cases. Gonorrhea was 19 times more common among blacks than whites; chlamydia was eight times more common; and syphilis was seven times more common, Douglas said.

Black women 15 to 19 years old had the highest rates of both chlamydia (9,647 per 100,000 population) and gonorrhea (2,956 per 100,000 population), according to the report.

Sexually transmitted diseases take a significant economic toll — the CDC estimates that STDs cost the U.S. health-care system an estimated $15.3 billion annually.

Douglas said greater public health campaigns are needed to reverse the trend.

“These diseases can be treated, and we need to have better awareness about how extensive these infections are and what the prevention opportunities are,” he said.

Dr. David L. Katz, director of the Yale University School of Medicine Prevention Research Center, said sexually transmitted diseases are a considerable public health burden.

“By serving up crucial details on where and in whom sexually transmitted diseases are most likely, this report helps inform disease-control programs. By highlighting the persistent prevalence of these diseases, it also issues a call to action,” he said.

More information

To learn more about sexually transmitted disease, visit the U.S. Centers for Disease Control and Prevention.

Protecting Yourself From STDsTo reduce your risk of STDs, Douglas recommends:Delaying sexual activity.Being careful about your sexual partners and using condoms.Chlamydia screening each year for sexually active young women.Getting tested regularly for gonorrhea, syphilis, chlamydia and HIV if you’re in a high-risk group.

SOURCES: John M. Douglas Jr., M.D., director, Division of STD Prevention, U.S. Centers for Disease Control and Prevention (CDC), Atlanta; David L. Katz, M.D., M.P.H., director, Prevention Research Center, Yale University School of Medicine, New Haven, Conn.; Jan. 13, 2009, CDC report, Sexually Transmitted Disease Surveillance, 2007

U.S. Chlamydia Infections Hit All-Time High – washingtonpost.com

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Doctors at Wake Forest University started their study after treating an 18-month-old girl who had developed severe respiratory distress after the salve had been put directly under her nose to relieve cold symptoms.

“The company is really clear that you don’t put it in the nose, and you never use it in kids under 2,” said lead researcher Dr. Bruce K. Rubin, professor and vice chair for research at Wake Forest’s Department of Pediatrics. “Sure enough, when we stopped all the medicine, the child got much better very quickly.”

Rubin’s experience prompted him to see if there had been other similar cases. “We encountered a few others that appeared to develop problems after using Vicks VapoRub. Parents never volunteered it, because they always thought it is just something you buy over-the-counter, and it’s not a real medicine, because you just rub it on, after all,” he said.

Rubin said Vicks VapoRub can make some adults feel better without really making them better. “For kids, because it can induce some inflammation, even a little bit, that little bit might be enough to tip over a child to having problems,” he said.

The findings were published in the January issue of the journal Chest.

To test whether Vicks VapoRub could cause respiratory distress, the researchers conducted experiments with ferrets. The animals were chosen because they have airways similar to human airways, Rubin said.

The researchers found that Vicks VapoRub increased mucus production by up to 59 percent; the ability to clear mucus was reduced by 36 percent.

David Bernens, a spokesman for Proctor & Gamble, the makers of Vicks VapoRub, doesn’t think one incident involving one child means that the product is unsafe.

“The product is safe and effective when used as directed,” he said. “To say it was the Vicks VapoRub that caused the respiratory distress — I’m not sure we have made that link yet.”

Dr. James A. L. Mathers Jr., president of the American College of Chest Physicians, said in an association news release: “Parents should consult with a physician before administering any over-the-counter medicine to infants and young children. Furthermore, the American College of Chest Physicians and several other health-care organizations have concluded that over-the-counter cough and cold medicines can be harmful for infants and young children and are, therefore, not recommended.”

In October, major manufacturers and the U.S. Food and Drug Administration announced that over-the-counter cough and cold medicines should not be used by children younger than 4 years old.

Dr. Daniel Craven, a pediatric pulmonologist at University Hospitals Rainbow Babies and Children’s Hospital in Cleveland, said parents shouldn’t use Vicks VapoRub, because it has no medicinal value and may even be dangerous.

“Previous research has failed to demonstrate any respiratory benefits of VapoRub, and conscientious pediatricians have thus usually tried to dissuade families from spending money on this and similarly ineffective therapies,” Craven said. “Although the findings are someone limited, this study raises the possibility that this product may not just be ineffective, but possibly might have adverse respiratory consequences — particularly if there is an intense exposure — as when it is applied directly under the nostrils.”

Vicks VapoRub Linked to Infant Breathing Problems – washingtonpost.com

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Federal health officials said the company’s peanut butter had not been conclusively linked to a national salmonella outbreak.

King Nut Companies said in a statement that it asked customers to stop distributing all peanut butter under its King Nut and Parnell’s Pride brands with a lot code that begins with the numeral “8.”

The peanut butter was distributed only through food service providers in Ohio, Michigan, North Dakota, Minnesota, Arizona, Idaho, New Hampshire, Massachusetts and Florida. It was not sold directly to consumers.

Preliminary laboratory testing found salmonella bacteria in a 5-pound container of King Nut brand creamy peanut butter, the Minnesota Department of Health said Friday.

The Minnesota tests had not linked it to the type of salmonella in the outbreak that has sickened almost 400 people in 42 states, but the department said additional results are expected early next week.

The federal Food and Drug Administration also is analyzing samples of peanut butter from King Nut and Peanut Corporation, spokeswoman Stephanie Kwisnek said Sunday. The agency has not conclusively linked the peanut butter to the strain of salmonella that has sickened people in the outbreak, she said.

King Nut’s president, Martin Kanan, said Sunday that the recall involved approximately 1,000 cases of peanut butter. He said he did not know the names of the company’s customers, but he planned to release more details Monday.

“We don’t know exactly where they sell to,” Kanan said. “They could sell cross-state, too.”

“We just want everybody to know that safety is our highest priority,” Kanan said. “We just wanted to recall it right away.”

King Nut, based in Solon, Ohio, said it canceled all orders with the manufacturer of its two peanut butter brands, Peanut Corporation of America, based in Lynchburg, Va.

Peanut Corporation said in a statement posted on its Web site that it is working with federal food and health officials to determine whether its products are connected to the national outbreak. PCA does not sell its products at grocery stores or directly to the public.

The Lynchburg company said the tainted container was found in the kitchen of a nursing facility, leaving it open to the possibility of cross-contamination from another source. The company did not say where the nursing facility was located or when the contaminated product was discovered.

Peanut Corporation’s owner and president, Stewart Parnell, declined to comment further on Sunday until the FDA and the U.S. Centers for Disease Control and Prevention complete their investigation.

CDC spokeswoman Bernadette Burden said Sunday that she had no new information on the case and did not know when additional test results would be available.

The CDC said Friday that 399 cases had been confirmed nationally, with about one in five of victims hospitalized. California has reported the most cases, with 55, followed by Ohio with 53. All the illnesses began between Sept. 3 and Dec. 29, but most of the people grew sick after Oct. 1.

The CDC has not confirmed any deaths associated with the outbreak.

The report of peanut butter contamination comes almost two years after ConAgra recalled its Peter Pan brand peanut butter, which was eventually linked to at least 625 salmonella cases in 47 states.

CDC officials say the bacteria in the current outbreak has been genetically fingerprinted as the Typhimurium type, which is among the most common sources of salmonella food poisoning.

Salmonella prompts peanut butter recall on Yahoo! Health

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King Nut Cos, in a statement released Saturday, said it immediately contacted its customers and asked them to remove all King Nut peanut butter and Parnell’s Pride peanut butter from the market.

The Solon, Ohio-based King Nut supplies peanut butter to food service companies that distribute the products to institutions like hospitals, schools, restaurants and nursing homes. The brands are not sold directly to consumers.

King Nut said it asked customers to stop distributing all peanut butter with lot codes beginning with the number eight and has canceled orders with the manufacturer, Peanut Corporation of America.

Officials for Peanut Corporation of America, based in Lynchburg, Virginia, could not be immediately reached for comment.

Martin Kanan, King Nut’s chief executive, said, “because we don’t manufacture peanut butter, we will do what we can to get this product out of distribution and will work with the manufacturer to inform others of this problem.”

On Friday, Minnesota health officials issued a product alert for King Nut brand creamy peanut butter after finding a jar that was contaminated with a strain of salmonella linked to an outbreak across the United States.

Since September, the outbreak of salmonella food poisoning has sickened at least 399 people in 42 states and sent at least 70 people to the hospital, according to the U.S. Centers for Disease Control and Prevention. The CDC, Agriculture Department, Food and Drug Administration and state health officials are trying to trace the source of the outbreak.

An outbreak of salmonella was linked to Peter Pan brand peanut butter in 2007. ConAgra Foods Inc closed a Georgia plant after more than 300 people became ill in that outbreak.

King Nut recalls salmonella-tainted peanut butter | Health | Reuters

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They may promise an easy fix to weight problems, but the FDA said they contain unlisted ingredients, including high doses of a powerful anti-obesity drug, as well as a suspected carcinogen.

Most of the diet pills appear to be from China and are sold mainly on the Internet.

The FDA is considering criminal charges against some of the companies. More information is available at chicagotribune.com/dietpills.

Fatloss Slimming, 2 Day Diet, 3x Slimming Power, 5x Imelda Perfect Slimming, 3 Day Diet Japan Lingzhi, 24 Hours Diet, 7 Diet Day/Night Formula, 7 Day Herbal Slim, 8 Factor Diet, 999 Fitness Essence, Extrim Plus and GMP.

Also:

Imelda Perfect Slim, Lida DaiDaihua, Miaozi Slim Capsules, Perfect Slim, Perfect Slim 5x, Phyto Shape, ProSlim Plus, Royal Slimming Formula, Slim 3 in 1, Slim Express 360, Slimtech, Somotrin, Superslim, TripleSlim, Zhen de Shou, Venom Hyperdrive 3.0

chicagotribune.com

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In a Dec. 19 health advisory, the Centers for Disease Control and Prevention (CDC) issued a warning that a flu strain in the United States is resistant to the popular drug Tamiflu, WebMD reported.

According to Reuters, three strains of flu are common in a normal flu season: H1N1, H3N2 and influenza B. The H1N1 strain prompted the advisory.

Tests showed that 49 of 50 H1N1 samples were resistant to Tamiflu, but the flu strain can be treated with other medications. A drug known as Relenza, or zanamivir, can be used to treat H1N1, as can a combination of Tamiflu and another drug known as rimantadine. However, Dr. Tim Uyeki of the CDC said zanamivir is not approved for children younger than 7.

One reason Tamiflu is popular is that it can be given to children as young as 1.

But doctors said it’s still early in the flu season, and the H1N1 strain might not be problematic for long. “There is no crystal ball here,” CDC Director Julie Gerberding said in a WebMD article. “We can’t predict if this strain will end up being the most important one this year. It could fizzle out.”

Gerberding told WebMD that the current flu vaccine protects against all three flu viruses, including the H1N1 strain. There is still time to get the flu shot because flu season generally does not peak before February.

A Whole New Flu Shot

Normally, one or two of the three flu strains targeted by annual vaccines remain part of the vaccine for several years, the Associated Press reports: “Public-health officials make educated guesses on what strains to include, taking into account the strains then circulating in the southern hemisphere.”

This year, for the first time, the process has changed and three totally new strains—two type A viruses called Brisbane 10 and Brisbane 59 that were first isolated in Australia last year and a type B virus first seen in Florida in 2006—will be circulated in the vaccine.

Furthermore, major flu vaccine manufacturers are already shipping the vaccines and plan to have all their doses to health care providers by late October in hopes of alleviating concerns that have arisen with past flu vaccine debacles.

Manufacturers hope the steps will work to create a more successful, more available flu shot. One of the Brisbane strains in this year’s vaccine showed up in the United States after the 2007–08 flu season began, too late to be included in that year’s vaccine, which ended up being only 44 percent effective, compared with 50–90 percent in typical years.

The Centers for Disease Control and Prevention worries that last year’s mismatch will discourage people from getting vaccinated this year, and plans to ramp up its flu vaccine campaign.

Background: The trouble with flu shots

In 2005, distribution and delivery problems left many doctors turning down patients who wanted vaccines until more flu shots came in.

An even more memorable event occurred in 2004, when vaccine manufacturer Chiron distributed 48 million tainted flu shots that had to be discarded, resulting in a major vaccine shortage. The incident raised “troubling questions about how close the tainted flu shots came to being used,” the San Francisco Chronicle reported that October. But more immediately, healthy adults were asked to forgo their flu shots that year, so that the vaccine could go to those most at risk, such as the very young, the elderly and those with certain medical conditions.

But even with improved delivery and potentially better-matched strains, perfecting the flu shot is a difficult matter. Scientists have to make an educated guess about which few flu strains to include in a vaccine every year, even though there are thousands of strains of influenza infecting people around the world at any given time.

Putting every single strain into the vaccine simply isn’t feasible, Slate reported in February: “very few are likely to make someone in the United States sick. Vaccinating people against a disease they’re never going to get is a risky proposition: We don’t know how the body would respond to a barrage of flu vaccinations.”

Flu Strain Spreading Through US Is Resistant to Popular Treatment

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