Overfed fruit flies develop insulin resistance; Represent new tool to study human diabetes

ScienceDaily (June 5, 2012) — Researchers find that fruit flies overloading on carbs and protein not only gain weight but have shortened life spans -- and develop insulin resistance, a hallmark of Type 2 human diabetes.

See Also:Health & MedicineDiabetesDiet and Weight LossObesityPlants & AnimalsMolecular BiologyCell BiologyAnimalsReferenceDiabetes mellitus type 2Blood sugarSouth Beach dietDiabetic diet

With Type 2 human diabetes climbing at alarming rates in the United States, researchers are seeking treatments for the disease, which has been linked to obesity and poor diet.

Now biologists at Southern Methodist University, Dallas, report they have developed a new tool that will help researchers better understand this deadly disease.

By manipulating the diets of healthy adult fruit flies, the researchers developed flies that are insulin-resistant, a hallmark of Type 2 diabetes.

Until now, researchers largely have relied on rats, mice and other animals as model systems for exploring the metabolic and genetic changes that take place in diabetics.

The fruit fly Drosophila melanogaster has been widely deployed in labs to investigate a wide range of human diseases, from Alzheimer's to cancer. But the scientific literature hasn't documented use of the adult fruit fly for studying the metabolic disruptions that are the hallmark of Type 2 diabetes. The fruit fly's advantages include its low cost and a very short lifespan, both of which enable scientists to undertake rapid screenings in their search for new genetic and drug treatments.

The insulin-resistant fruit fly was developed in the lab of SMU biologist Johannes H. Bauer, principal investigator for the study. It was accomplished by feeding fruit flies a diet high in nutrients, said Bauer, an assistant professor in SMU's Department of Biological Sciences. That process mimics one of the ways insulin resistance develops in humans -- overeating to the point of obesity.

The lab's insulin-resistant fruit flies now can serve as a highly relevant and efficient model for studying Type 2 diabetes.

"We learned that by manipulating the nutrients of fruit flies, we can make them insulin resistant," Bauer said. "With this insulin-resistant model we can now go in with pinpoint precision and study the molecular mechanisms of insulin resistance, as well as drug treatments for the condition, as well as how to treat obesity, how to block insulin resistance and how metabolic changes from a specific diet develop. The possibilities are endless."

The researchers reported their findings in the article "Development of diet-induced insulin resistance in adult Drosophila melanogaster," published in Biochimica et Biophysica Acta -- Molecular Basis of Disease.

Two overfeeding diets, carb and protein, both result in insulin resistance

Insulin, produced by the pancreas, is the hormone that tells our cells to absorb glucose, a necessary sugar molecule that provides our body, particularly the brain, with the energy to function, make repairs, move and grow.

In Type 2 diabetes, a person is insulin-resistant because his or her cells fail to respond to insulin's signal to absorb glucose. The disregulation of glucose upsets the body's delicate internal equilibrium, causing massive disruptions in normal cellular processes. These interruptions manifest in multiple disease symptoms, making Type 2 diabetes difficult to characterize, treat and cure.

To provide a good base model organism to study aspects of this complex disease, researchers in the Bauer lab wanted to determine whether flies develop diabetes-like metabolic changes when fed different diets. The researchers developed the insulin-resistant flies in two different ways: One group of fruit flies was overfed a carbohydrate-loaded diet; a second group of flies was overfed a protein-loaded diet. In both cases, the disruption had a profoundly detrimental effect on the flies' health and physiology.

SMU biologist Siti Nur Sarah Morris, lead author on the study, said the results the researchers observed were both expected and unexpected. The researchers expected the flies to gain weight, which they did. Carb-loaded flies gained excessive weight and got fat, just like humans who overeat sweets, french fries, pasta and ice cream. Protein-loaded flies also gained weight, but upon extreme overfeeding they lost weight, just like humans who follow the popular Atkins Diet, a weight loss program in which participants eat only meat, seafood and eggs.

The researchers expected the carb-loaded fruit flies to develop insulin resistance, which they did.

In a surprising result, however, the fruit flies that overate protein also developed insulin resistance, but at a quicker and more severe rate.

"Carb-loaded flies gain weight. Protein-loaded flies gain and then lose weight. So the two diets have exactly opposite effects on metabolism," Bauer said. "But too much of either one of them causes insulin resistance. That surprised us."

Overfed flies had shortened lifespans, differences in fertility

In other findings, carb-loaded flies experienced a profound decline in egg-laying, a measurement of fertility. In contrast, protein-loaded flies first experienced increased egg-laying, but the extreme diet led to decreased egg laying. Both diets led to shortened longevity, the scientists reported.

"The high-protein flies looked frail and unhealthy. They moved less, almost as if sedated," Morris said. "The fatter flies on the high-carb diet had massively decreased fertility; they flew less but still tried to move."

While both diets resulted in insulin resistance, differences were remarkable.

"The carb data imply a linear relationship between carb levels and health. The more carbs, the more weight, the more sugar storage and fat, the more insulin resistance and the less fertility," Bauer said. "But with protein, this relationship becomes parabolic, meaning all readouts go up, then come down again. The decreased storage we liken to a catabolic state that is primarily destructive for the body's optimum metabolic functioning, such as the ketosis typically seen in people eating Atkins-type diets."

Besides Morris and Bauer, other authors on the study were SMU students Claire Coogan, Khalil Chamseddin and Santharam Kolli. Other co-authors, from Pennington Biomedical Research Center, Baton Rouge, La., are Jeffrey N. Keller, director, Institute of Dementia Research & Prevention, and Sun Ok Fernandez-Kim. The research was funded by the National Institute on Aging.

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Complex world of gut microbes fine-tune body weight

ScienceDaily (June 6, 2012) — Microorganisms in the human gastrointestinal tract form an intricate, living fabric made up of some 500 to 1000 distinct bacterial species, (in addition to other microbes). Recently, researchers have begun to untangle the subtle role these diverse life forms play in maintaining health and regulating weight.

See Also:Health & MedicineObesityDiet and Weight LossGastrointestinal ProblemsPlants & AnimalsMicrobes and MoreFoodMicrobiologyStrange ScienceReferenceAppetiteMicroorganismMalnutritionBody mass index

In a new study appearing in the journal Nutrition in Clinical Practice, researcher Rosa Krajmalnik-Brown and her colleagues at the Swette Center for Environmental Biotechnology at Arizona State University's Biodesign Institute in collaboration with John DiBaise from the Division of Gastroenterology at the Mayo Clinic, review the role of gut microbes in nutrient absorption and energy regulation.

According to Krajmalnik-Brown, "Malnutrition may manifest as either obesity or undernutrition, problems of epidemic proportion worldwide. Microorganisms have been shown to play an important role in nutrient and energy extraction and energy regulation although the specific roles that individual and groups/teams of gut microbes play remain uncertain."

The study outlines the growth of varied microbial populations -- from birth onwards -- highlighting their role in extracting energy from the diet. The composition of microbial communities is shown to vary with age, body weight, and variety of food ingested; as well as in response to bariatric surgery for obesity, use of antibiotics and many other factors.

Based on current findings, the authors suggest that therapeutic modification of the gut microbiome may offer an attractive approach to future treatment of nutrition-related maladies, including obesity and a range of serious health consequences linked to under-nutrition.

Micromanagers

The microbes in the human gut belong to three broad domains, defined by their molecular phylogeny: Eukarya, Bacteria, and Achaea. Of these, bacteria reign supreme, with two dominant divisions -- known as Bacteroidetes and Firmicutes -- making up over 90 percent of the gut's microbial population. In contrast, the Achaea that exist in the gut are mostly composed of methanogens (producers of methane) and specifically by Methanobrevibacter smithii -- a hydrogen-consumer.

Within the bacterial categories however, enormous diversity exists. Each individual's community of gut microbes is unique and profoundly sensitive to environmental conditions, beginning at birth. Indeed, the mode of delivery during the birthing process has been shown to affect an infant's microbial profile.

Communities of vaginal microbes change during pregnancy in preparation for birth, delivering beneficial microbes to the newborn. At the time of delivery, the vagina is dominated by a pair of bacterial species, Lactobacillus and Prevotella. In contrast, infants delivered by caesarean section typically show microbial communities associated with the skin, including Staphylococcus, Corynebacterium, and Propionibacterium. While the full implications of these distinctions are still murky, evidence suggests they may affect an infant's subsequent development and health, particularly in terms of susceptibility to pathogens.

Diet and destiny

After birth, diet becomes a critical determinant in microbial diversity within the gut. Recent research indicates that microbial populations vary geographically in a manner consistent with regional differences in diet. Children in rural areas of Burkina Faso for example showed much more abundant concentrations of Bacteroidetes compared with their cohorts in Italy, a finding consistent with the African children's plant-rich diet.

While microbiomes appear to have adapted to local diets, changes in eating habits significantly alter composition of gut microbes. Variations in macronutrient composition can modify the structure of gut microbiota in a few days -- in some cases, a single day. Studies in mice show that changing from a low fat, plant polysaccharide diet to a Western diet high in sugar and fat rapidly and profoundly reconfigures the composition of microbes in the gut.

Another modifier of gut microbe composition is gastric bypass surgery, used in certain cases to alleviate conditions of serious obesity. In earlier work, the authors found that the post-surgical microbial composition of patients who underwent so-called Roux-en-Y gastric bypass was distinct from both obese and normal weight individuals.

"Obesity affects more than a third of adults in the U.S. and is associated with a raft of health conditions including heart disease, stroke, type 2 diabetes and certain forms of cancer," says Dr. John DiBaise. The authors further note that concentrations in the blood of lipopolysaccharides derived from gut bacteria increase in obese individuals, producing a condition known as metabolic endotoxemia. The disorder has been linked with chronic, systemic, low-level inflammation as well as insulin resistance.

Energy harvest

In the current review, the cycle of microbial energy extraction from food, involving hydrogen-producing and consuming reactions in the human intestine, is described in detail. Short chain fatty acids (SCFAs) are a critical component in this system. During the digestive process, fermentation in the gut breaks down complex organic compounds, producing SCFA and hydrogen. The hydrogen is either excreted in breath or consumed by 3 groups of microorganisms inhabiting the colon: methanogens, acetogens and sulfate reducers.

Research conducted by the authors and others has demonstrated that hydrogen-consuming methanogens appear in greater abundance in obese as opposed to normal weight individuals. Further, the Firmicutes -- a form of acetogen -- also seem to be linked with obesity. Following fermentation, SCFAs persist in the colon. Greater concentration of SCFAs, especially propionate, were observed in fecal samples from obese as opposed to normal weight children. (SCFAs also behave as signaling molecules, triggering the expression of leptin, which acts as an appetite suppressor.)

While it now seems clear that certain microbial populations help the body process otherwise indigestible carbohydrates and proteins, leading to greater energy extraction and associated weight gain, experimental results have shown some inconsistency. For example, while a number of studies have indicated a greater prevalence of Bacteroidetes in lean individuals and have linked the prevalence of Firmicutes with obesity, the authors stress that many questions remain.

Alterations in gut microbiota are also of crucial concern for the one billion people worldwide who suffer from undernutrition. Illnesses resulting from undernutrition contribute to over half of the global fatalities in children under age 5. Those who do survive undernutrition often experience a range of serious, long-term mental and physical effects. The role of gut microbial diversity among the undernourished has yet to receive the kind of concentrated research effort applied to obesity -- a disease which has reached epidemic proportions in the developed world.

Exploiting microbes affecting energy extraction may prove a useful tool for non-surgically addressing obesity as well as treating undernutrition, though more research is needed for a full understanding of regulatory mechanisms governing the delicate interplay between intestinal microbes and their human hosts.

Dr. Krajmalnik-Brown and colleagues at the Biodesign Institute and Mayo Clinic are currently in the second year of an NIH-funded study to better understand the role of the gut microbiome in the success or failure of surgical procedures performed to treat obesity including the Roux-en-Y gastric bypass, adjustable gastric band and vertical sleeve gastrectomy.

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To quit smoking, try eating more veggies and fruits

ScienceDaily (June 6, 2012) — If you're trying to quit smoking, eating more fruits and vegetables may help you quit and stay tobacco-free for longer, according to a new study published online by University at Buffalo public health researchers.

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The paper, in the journal Nicotine and Tobacco Research, is the first longitudinal study on the relationship between fruit and vegetable consumption and smoking cessation.

The authors, from UB's School of Public Health and Health Professions, surveyed 1,000 smokers aged 25 and older from around the country, using random-digit dialing telephone interviews. They followed up with the respondents fourteen months later, asking them if they had abstained from tobacco use during the previous month.

"Other studies have taken a snapshot approach, asking smokers and nonsmokers about their diets," says Gary A. Giovino, PhD, chair of the Department of Community Health and Health Behavior at UB. "We knew from our previous work that people who were abstinent from cigarettes for less than six months consumed more fruits and vegetables than those who still smoked. What we didn't know was whether recent quitters increased their fruit and vegetable consumption or if smokers who ate more fruits and vegetables were more likely to quit."

The UB study found that smokers who consumed the most fruit and vegetables were three times more likely to be tobacco-free for at least 30 days at follow-up 14 months later than those consuming the lowest amount of fruits and vegetables. These findings persisted even when adjustments were made to take into account age, gender, race/ethnicity, education, household income and health orientation.

They also found that smokers with higher fruit and vegetable consumption smoked fewer cigarettes per day, waited longer to smoke their first cigarette of the day and scored lower on a common test of nicotine dependence.

"We may have identified a new tool that can help people quit smoking," says Jeffrey P. Haibach, MPH, first author on the paper and graduate research assistant in the UB Department of Community Health and Health Behavior. "Granted, this is just an observational study, but improving one's diet may facilitate quitting."

Several explanations are possible, such as less nicotine dependence for people who consume a lot of fruits and vegetables or the fact that higher fiber consumption from fruits and vegetables make people feel fuller.

"It is also possible that fruits and vegetables give people more of a feeling of satiety or fullness so that they feel less of a need to smoke, since smokers sometimes confuse hunger with an urge to smoke," explains Haibach.

And unlike some foods which are known to enhance the taste of tobacco, such as meats, caffeinated beverages and alcohol, fruits and vegetables do not enhance the taste of tobacco.

"Foods like fruit and vegetables may actually worsen the taste of cigarettes," says Haibach.

While smoking rates in the U.S. continue to decline, Giovino notes, the rate of that decline has slowed during the past decade or so. "Nineteen percent of Americans still smoke cigarettes, but most of them want to quit," he says.

Haibach adds: "It's possible that an improved diet could be an important item to add to the list of measures to help smokers quit. We certainly need to continue efforts to encourage people to quit and help them succeed, including proven approaches like quitlines, policies such as tobacco tax increases and smoke-free laws, and effective media campaigns."

The UB researchers caution that more research is needed to determine if these findings replicate and if they do, to identify the mechanisms that explain how fruit and vegetable consumption may help smokers quit. They also see a need for research on other dietary components and smoking cessation.

Gregory G. Homish, PhD, assistant professor in the UB Department of Community Health and Health Behavior, also is a co-author.

Funding was provided by the Robert Wood Johnson Foundation and Legacy®.

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Role of fungus in digestive disorders explored

ScienceDaily (June 6, 2012) — Cedars-Sinai researchers say their examination of the fungi in the intestines suggests an important link between these microbes and inflammatory diseases such as ulcerative colitis.

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In the new study, published in the June 8 issue of Science, researchers at Cedars-Sinai's Inflammatory Bowel and Immunobiology Research Institute identified and characterized the large community of fungi inhabiting the large intestine in a model of the disease.

The digestive tract is home to a large number of micro-organisms. In fact, with an estimated 100 trillion bacteria residing in the gut, microbes outnumber human cells in the body. Some are necessary to aid in digesting food, producing necessary vitamins and suppressing the growth of harmful microbes. Others are harmful to the body, contributing to illnesses such as Crohn's disease, ulcerative colitis and obesity.

Modern DNA-sequencing technology has revolutionized the study of these microbes in the last decade, allowing the role of bacteria in disease to be understood more clearly, as is shown in the Cedars-Science research published in Science.

"It's long been recognized that fungi must also exist in the gut, but we're among the first to investigate what types, how many, and whether they're important in disease," said David Underhill, PhD, associate professor and director of the Graduate Program in Biomedical Science and Translational Medicine, who led the study. "We were truly stunned to see just how common fungi are, identifying more than 100 different types" and seeing linkages to digestive disorders.

An estimated 1.4 million Americans have Inflammatory Bowel Disease, or IBD, a chronic digestive disorder, and about 30,000 new cases are diagnosed annually. Ulcerative colitis, one of the most common types of IBD, causes inflammation and ulcers in the top layers of the lining of the large intestine. Common symptoms include abdominal pain, diarrhea, bleeding, fatigue, weight loss and loss of appetite. Ulcerative colitis patients can be at increased risk of developing colorectal cancer.

"This study takes us an important step closer to understanding how fungi contribute to disease, as well as significantly expanding our understanding of what types of fungi are living in our bodies," said Iliyan Iliev, PhD, a Cedars-Sinai research scientist and lead author on the study.

To determine fungi contribute to inflammatory disease, the study homed in on a protein called Dectin-1, produced by white blood cells and used by the immune system to detect and kill fungi. In an animal model of the disease, researchers found that the protein is important in protecting against inflammation caused by indigenous fungi. The finding has significant implications for human disease, as scientists at the Cedars-Sinai Medical Genetics Institute found a variant of the gene for Dectin-1 that is strongly associated with severe forms of ulcerative colitis.

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Ore. woman wins $900K in lawsuit over herpes claim

An Oregon jury has awarded $900,000 to a 49-year-old woman who claimed that a 69-year-old Portland man intentionally gave her a sexually transmitted disease after they met on an online dating website.

The Oregonian reports (http://is.gd/cdR7MI ) that it was the first time that a case of a person suing another for intentionally transmitting genital herpes went to trial in Oregon, according to lawyers. They say similar cases have been settled out of court.

The man testified he didn't know he was contagious. His lawyer argued that she was lying about her sexual history and may have had sex with other men who gave her the disease.

The woman from Beaverton, Ore., sued after she suffered repeated painful outbreaks of the disease. The jury award was for pain and suffering.

___

Information from: The Oregonian, http://www.oregonlive.com

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Oregon woman wins $900K; says date gave her herpes

An Oregon jury has awarded $900,000 to a woman who claimed a retired dentist infected her with genital herpes, in a rare case in which a dispute over a sexually transmitted disease went to a jury trial.

The 49-year-old woman, who filed the suit under a pseudonym, testified last week that she suffered painful outbreaks and spiraled into depression following a sexual encounter with the 69-year-old man she met through the dating website eHarmony.

"I told the jury he's dangerous, and I believe he is," said Randall Vogt, the attorney for the woman, who declined to be interviewed.

High-profile lawsuits accusing celebrities of herpes transmission have been in the news for a quarter-century, but such lawsuits remain relatively rare and typically do not go to trial. The award issued Friday is believed to be the largest of its kind in Oregon. A similar 1996 case ended in a $550,000 settlement.

Vogt said the cases are uncommon because they are difficult to prove and typically embarrassing for the claimants. Moreover, it does not make sense to pursue a civil lawsuit unless the defendant has the money to pay a potential judgment.

The retired dentist, whose name was also omitted from the lawsuit, has had herpes since 1991. He testified he did not know he was contagious because he was not experiencing an active outbreak at the time the pair had sex, which was during their fourth date.

Roughly 1 of 6 adults in the United States has genital herpes, and transmission can occur regardless of whether infected persons have visible sores, according to the Centers for Disease Control and Prevention.

The suit alleged negligence and battery. On the question of negligence, the jury found the man 75 percent responsible and the woman 25 percent. The jurors determined the dentist committed battery because he intentionally engaged in an activity that harmed his date.

"We all felt he should have told her," juror Noah Brimhall told The Oregonian newspaper. "He had the responsibility to tell her."

The dentist's attorney, Shawn Lillegren, argued that the woman was negligent because she did not demand that his client wear a condom. He also portrayed the woman as greedy in his closing argument to jurors.

"Go for a million

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Sex bug growing resistant to drugs, WHO warns

A potentially dangerous sexually transmitted disease that infects millions of people each year is growing resistant to drugs and could soon become untreatable, the World Health Organization said Wednesday.

The U.N. health agency is urging governments and doctors to step up surveillance of antibiotic-resistant gonorrhea, a bacterial infection that can cause inflammation, infertility, pregnancy complications and, in extreme cases, lead to maternal death. Babies born to mothers with gonorrhea have a 50 percent chance of developing eye infections that can result in blindness.

"This organism has basically been developing resistance against every medication we've thrown at it," said Dr. Manjula Lusti-Narasimhan, a scientist in the agency's department of sexually transmitted diseases. This includes a group of antibiotics called cephalosporins currently considered the last line of treatment.

"In a couple of years it will have become resistant to every treatment option we have available now," she told The Associated Press in an interview ahead of WHO's public announcement on its 'global action plan' to combat the disease.

Lusti-Narasimhan said the new guidance is aimed at ending complacency about gonorrhea and encouraging researchers to speed up their hunt for a new cure.

Once considered a scourge of sailors and soldiers, gonorrhea

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Gonorrhea growing resistant to drugs, WHO warns

A sexually transmitted disease that infects millions of people each year is growing resistant to drugs and could soon become untreatable, the World Health Organization said Wednesday.

The U.N. health agency is urging governments and doctors to step up surveillance of antibiotic-resistant gonorrhea, a bacterial infection that can cause inflammation, infertility, pregnancy complications and, in extreme cases, lead to maternal death. Babies born to mothers with gonorrhea have a 50 percent chance of developing eye infections that can result in blindness.

"This organism has basically been developing resistance against every medication we've thrown at it," said Dr. Manjula Lusti-Narasimhan, a scientist in the agency's department of sexually transmitted diseases. This includes a group of antibiotics called cephalosporins currently considered the last line of treatment.

"In a couple of years it will have become resistant to every treatment option we have available now," she told The Associated Press in an interview ahead of WHO's public announcement on its 'global action plan' to combat the disease.

Lusti-Narasimhan said the new guidance is aimed at ending complacency about gonorrhea and encouraging researchers to speed up their hunt for a new cure.

Once considered a scourge of sailors and soldiers, gonorrhea

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Drug-Resistant Gonorrhea Spreading

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Drug-Resistant Gonorrhea Spreading, Says World Health Organization

ABC News – 22 hrs ago

The World Health Organization is warning medical providers around the world about the potential spread of a drug-resistant form of gonorrhea, urging them to be vigilant in spotting the disease and taking steps to stop its spread.

The health agency plans to issue a "global action plan," hoping to raise awareness of the disease and encouraging research efforts to find a cure.

"This organism has basically been developing resistance against every medication we've thrown at it," Dr. Manjula Lusti-Narasimhan, a scientist in the WHO's department of sexually transmitted diseases told The Associated Press.

She added that in a couple of years, the bacterium will no longer respond to treatment with cephalosporin antibiotics, the drugs currently used to treat gonorrhea.

Cases of antibiotic-resistant gonorrhea have so far been identified in Japan, United Kingdom, Australia, France, Sweden and Norway, the AP reported, but it's likely that there are undetected cases in other countries.

The Centers for Disease Control and Prevention warned about the rising rate of drug-resistant gonorrhea in an editorial published in the New England Journal of Medicine back in February.  So far, there have been no reports of any cases of gonorrhea resistant to cephalosporins in the U.S., the agency says on its website, but it does have a surveillance system in place.

"There is much to do, and the threat of untreatable gonorrhea is emerging rapidly," the authors wrote.

In 2006, the prevalence of resistance to cephalosporins was about 0.1 percent, but by the middle of 2011, that number rose to 1.7 percent, the authors said.  CDC's first warnings about drug resistance came in 2010.

The most alarming part of the story, they said, is that cephalosporins are the only remaining drugs of choice that work. They have to be taken along with two other antibiotics.

"A major component of the threat is that there really is no backup plan if - most likely when - these more resistant organisms become more prevalent," Dr. Kenneth Fife, an infectious disease expert and professor of medicine at Indiana University Medical School, told ABC News in response to the CDC's commentary. "There are very few new drugs that have activity against the gonococcus, no clinical trials to establish the efficacy of the few drugs that might have promise."

In many cases, there are no symptoms of gonorrhea, so an infected person can spread the disease without even knowing he or she has it.

Fife added that it's unlikely that experts will be able to prevent an outbreak from happening, so it's urgent to research and develop new treatments.

If the situation progresses to the point where we are in a "post-antibiotic era," Dr. William Schaffner, chair of preventive medicine at Vanderbilt University Medical Center, said experts will be "hard-pressed to provide quick and effective therapy to patients."

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Drug-resistant gonorrhoea on the rise, warns WHO

"The World Health Organization warned on Wednesday of a spreading resistance to drugs used to treat the sexually transmitted disease gonorrhoea. The WHO has called for greater vigilance on the correct use of antibiotics and more research into alternative treatments. (AFP Photo/Philippe Huguen)" title

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Sandoz recalls some Introvale birth control pills

Reuters – 17 hrs ago (Reuters) - Novartis AG's unit Sandoz is voluntarily recalling 10 lots of its generic Introvale birth control pills after a consumer recently reported a packaging flaw.

Sandoz said in a post on its website on Tuesday that it decided on the recall after a consumer reported that white placebo tablets were mistakenly placed in the wrong row of a 13-row card.

"While the white placebo tablets can be clearly distinguished from the peach-colored active tablets, the risk of an unintended pregnancy for a patient taking the wrong tablet over several days cannot be excluded," Sandoz said, noting it is not aware of any adverse events stemming from the flaw.

The lot numbers involved in the recall are: LF00478C, LF00479C, LF00551C, LF00552C, LF00687C, LF00688C, LF00763C, LF00764C, LF00765C and LF01261C. These lots were distributed only in the United States between January 2011 and May 2012, Sandoz said.

If a patient finds a white placebo tablet in any position other than the 13th and final row, for the 13th week, she should immediately start using a non-hormonal form of contraception, according to a notice sent out on Wednesday by the U.S. Food and Drug Administration.

(Reporting By Phil Wahba; editing by Andre Grenon)

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