FDA To Investigate Safety Of Inhalable Caffeine

February 20th, 2012

ABC News

By: Mark Greenblatt

The Food and Drug Administration will launch a safety investigation of a new product that allows consumers to inhale caffeine through a lipstick-sized portable device, rather than drinking it.

AeroShot delivers 100 milligrams of caffeine per use, and comes in bright colored packages that describe it as “pure energy,” and “breathable energy anytime, anyplace.”

The manufacturer, Breathable Foods Inc., put it on the market in New York, Massachusetts, and in France late last month.

“You could easily overdose or succumb to toxicity associated with the caffeine ingestion,” Dr. Bruce Goldberger told ABC News. “You could mix it with alcohol in a social setting and also I’m troubled by its availability, potentially at home where young children can get a hold of it.”

Sen. Charles Schumer of New York said he shares those concerns.

“A new product like AeroShot raises questions that need to be answered before allowing consumers, especially teens and kids, to use and abuse it,” he said. “The AeroShot caffeine-inhaler is being marketed as a party enhancer; it can facilitate excessive drinking and its effects have never been examined by independent regulators to determine their impact on the human body and in combination with alcohol, especially for adolescents.”

The inventor of AeroShot, Harvard biomedical professor David Edwards, says his product is as safe as a cup of coffee, which provides roughly the equivalent dose of caffeine.

“I think that we are absolutely welcoming a dialogue with the FDA,” he said. “As I say, this is a new way of delivering food in your mouth, and we’re confident that as they look at the product that they will confirm what we hold, that the product is both safe and follows FDA regulations.”

Edwards was able to bring Aeroshot to the market without an FDA review being required because it is sold as a dietary supplement. ABC News asked Edwards if he or his company had done any studies of the health effects of AeroShot on children or teenagers.

“The answer is no, we did not do tests on children,” he said, explaining that children and teenagers are not part of his target market. “We need to be really clear what a company responsibly does to test the safety of their product, and we’ve followed those safety regulations.”

Edwards says his product delivers a lower dose of caffeine than many energy drinks or caffeine pills currently on the market, and says it comes in a controlled, smaller dose of caffeine.

Edwards says demand for the product is eclipsing anything he could have ever anticipated, and increasing.

ABC News found the product on store shelves throughout New York and around college campuses. We visited three delis near Columbia University — two sold us their shelf stock, while the third store was already sold out.

“I would try it during something like finals week,” said Thalia Dergham, a Columbia University student. Dergham said, though, that she would likely not be a regular consumer of the product outside of high stress times.

Other students were not so willing.

“It looks intense,” said Kristin Simmons, a Columbia University art history and visual arts major. “It looks like one of those monster Red Bull drinks.”

After announcing its review, the FDA is now likely to examine the health effects of inhaling the caffeine on at-risk populations, along with looking into the potential health effects of use when combined with alcohol.

“FDA will review information brought to the agency’s attention about this product,” the agency said in a statement. “As with any complaint or concern we receive about FDA-regulated products, we will consider whether a violation of the Federal Food, Drug, and Cosmetic Act has occurred and, if so, whether regulatory action is warranted in light of FDA’s enforcement priorities and resources.”

The product’s manufacturer has come under fire for a round of advertisements that seem to show its use by younger men and women who are out at nightclubs, where alcohol may be present.

ABC News asked the inventor of the product about those ads. Edwards said the product itself is safe and fundamentally sound, but there is ongoing discussion within his company about how to market it and where to sell it.

“Speaking as an innovator, you’re not developing a product thinking of targeting people that it’s going to hurt. And so on the contrary, the motivation of this product was to actually create a healthier and more accessible way of having caffeine, when you need it, as opposed to overdoing yourself often when you don’t need it.”

For The Full Report Go To ABC News

Fructose Is Found To Increase Cardiovascular And Diabetes Risk In Adolescents

February 16, 2012

Natural News

By John Phillip

Researchers at the Medical College of Georgia at Georgia Health Sciences University have published evidence that cardiovascular disease and diabetes risk is present in the blood fractions of adolescents who consume a lot of fructose, a scenario that worsens in the face of excess belly fat. Published in theJournal of Nutrition, scientists determined that high dietary fructose consumption results in lower levels of cardiovascular protectors such as HDL cholesterol and adiponectin, due in part to how the body metabolizes the fruit-based mega-sweetener at the cellular level. Excess body fat accumulated around the mid-section, a rapidly growing problem in adolescents, compounds the problem when compared to those with less visceral fat deposits. A wealth of scientifically validated research studies now highlight the importance of eliminating fructose in all its forms from the diets of both adults and children alike to dramatically reduce risk of diabetes and heart disease.

The study detailed an analysis of 559 adolescents, aged 14 to 18 and detailed cardiovascular risk factors including high blood pressure, fasting glucose, insulin resistance and blood inflammatory factors. Excess fat around the midsection was found to exacerbate the identified risk factors, as compared to those with generalized fat right beneath the skin known as subcutaneous fat, where an association was not evident.

Click here for the full report from Natural News

Fructose Is Found To Increase Cardiovascular And Diabetes Risk In Adolescents

February 15, 2012

Natural News

By John Philip

“You would think that school would stop selling soda to the students after reports like this. But nope, they get too much money from Coke.” –KTRN

Researchers at the Medical College of Georgia at Georgia Health Sciences University have published evidence that cardiovascular disease and diabetes risk is present in the blood fractions of adolescents who consume a lot of fructose, a scenario that worsens in the face of excess belly fat. Published in the Journal of Nutrition, scientists determined that high dietary fructose consumption results in lower levels of cardiovascular protectors such as HDL cholesterol and adiponectin, due in part to how the body metabolizes the fruit-based mega-sweetener at the cellular level. Excess body fat accumulated around the mid-section, a rapidly growing problem in adolescents, compounds the problem when compared to those with less visceral fat deposits. A wealth of scientifically validated research studies now highlight the importance of eliminating fructose in all its forms from the diets of both adults and children alike to dramatically reduce risk of diabetes and heart disease.

The study detailed an analysis of 559 adolescents, aged 14 to 18 and detailed cardiovascular risk factors including high blood pressure, fasting glucose, insulin resistance and blood inflammatory factors. Excess fat around the midsection was found to exacerbate the identified risk factors, as compared to those with generalized fat right beneath the skin known as subcutaneous fat, where an association was not evident.

Click here for the full report.

Finland Suspends H1N1 Vaccine, Suspects Narcolepsy

August 27th, 2010

The Epoch Times

By: Stephanie Lam and Chowa Choo

The Finnish National Institute for Health (THL) proposed suspending vaccinations for H1N1 swine flu, due to suspected links to increased narcolepsy in children and adolescents, the body announced this week.

Six cases of narcolepsy, a chronic disorder causing excessive daytime sleepiness and extreme fatigue, have been reported after patients had been receiving the Pandemrix vaccine.

Six cases of narcolepsy is consistent with annual averages, reports THL, but all of these patients were affected after being vaccinated, and there are nine additional cases that have not yet been confirmed.

The precautionary measure will take effect until the actual cause of the current health issue can be established. Preliminary results of the investigation will take several months to be known, says the THL.

“A number of different reasons may be behind the observed rise in the incidence of narcolepsy: A(H1N1) infection, vaccination, a compound effect of infection and vaccination, or some other factor entirely. Infections in general are known to cause narcolepsy,” said a THL press release.

In Sweden, the Medical Products Agency started a similar investigation on Aug. 19 for the same reason. Sweden has bought 18 million doses of the vaccine, sufficient for everyone in the country to have two injections. In Europe, about 30 million people have been vaccinated, and worldwide at least 90 million.

Last winter, 29 million children in the United States were given a seasonal influenza shot that incorporates the swine flu vaccine, but according to Tom Skinner, press officer of Centers for Disease Control and Prevention, narcolepsy associated with the vaccine has not been reported.

According to Marjo Renko, chairwoman of Finland’s national group of experts on vaccines, a substance was identified as possibly cause narcolepsy, but later denied it.

“There is no proof that the increase in narcolepsy would be linked with the vaccines. We do not suspect anything. This is mere speculation,” she said, according to Helsingin Sanomat.

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Obese Patients Need Larger Needles

February 8th, 2010

Reuters

In a new study, the researchers report that using a standard 1-inch needle to immunize obese adolescents against hepatitis B virus produced a much weaker effect than using a longer needle.

“As obesity rises in the US, we need to be aware that the standard of care may have to change to protect obese youth,” study co-author Dr. Amy Middleman of Baylor College of Medicine in Houston told Reuters Health.

Over three years her team vaccinated 22 young women and two young men in the shoulder, randomly assigning them to be injected with either a 1-inch or a 1.5-inch needle.

Once injected, vaccines trigger production of small molecules called antibodies, which kick-start our immune system if we are ever attacked by the virus again.

The two groups turned out to have different antibody counts depending on the needle used. In those injected with the short one, the number was almost halved.

Although everyone in the study had enough antibodies to be considered protected against hepatitis B, a lower count generally means a less robust response.

“It gives us more evidence of the importance of choosing the right needle length,” said Middleman, “because we just don’t know what the impact could be in other vaccines.”

The results are no surprise, said Dr. Gregory Poland, who studies vaccines at the Mayo Clinic in Rochester, Minnesota. For years, doctors have known that vaccines tend not to work as well in heavy people. Whether the obese have weaker immune systems, or fat keeps shorter needles from reaching muscles, where the vaccines can affect immune cells, was unclear.

The introduction of the hepatitis B vaccine in the 1980s offered some clues. Soon after doctors began using the vaccine, they realized that it was failing to protect some female nurses.

At the time, the shot was given in the buttock, Poland told Reuters Health, and was thwarted by the padding there.

Instead of entering the muscle as it was supposed to, the vaccine apparently was broken down in the fat tissue, where it had little chance to affect immune cells. So doctors began giving the shot in the less-padded shoulder.

With the obesity epidemic now adding extra insulation to the shoulder, “our needles are going to have to be longer,” Poland said.

And those long needles aren’t as unpleasant as they sound. In fact, Poland said, “they turn out to be less painful and have fewer side effects.”

The Centers for Disease Control and Prevention recommends longer needles in obese patients, but it is unclear how many doctors follow these guidelines, or even know about them.

Women are more affected by needle length than men, because their fat distribution is different. But even obese women shouldn’t be overly concerned until more research has been done, Middleman cautioned.

“Should you go back and get all your immunizations repeated?” she said, “No, I don’t think so.”

Click here for the full report

Psychiatric Meds in Children Leading to Rapid Weight Gain

October 27, 2009

U.S News

By Nathan Seppa, Science News

Many young children and adolescents taking drugs for severe psychiatric problems gain substantial weight and, in some cases, show increased levels of LDL cholesterol and triglycerides in their blood, researchers report in the Oct. 28 Journal of the American Medical Association.

Although the data from this study need to be replicated over a longer time frame, the findings nonetheless raise worrisome questions about anti-psychotic drugs that often benefit children who have schizophrenia, autism, tics, severe bipolar disorder or aggressive behavior.

“We are between a rock and a hard place here,” says study coauthor Christoph Correll, a psychiatrist at the Zucker Hillside Hospital in Glen Oaks, N.Y. These mental disorders are severe and can lead to suicide or to educational problems and emotional scars, he says. On the other hand, weight gain during youth predisposes an individual to chronic health problems later in life, he says.

Weight gain has been noticed before in children and adolescents taking commonly prescribed drugs for severe psychiatric problems. But studies seeking to link that weight gain to the medications were often muddied because patients had taken one of the drugs beforehand at some point—and may have already put on weight from it or reset their body metabolism to adjust to the drug somehow.

In the new study, Correll and his colleagues monitored 272 children, ages 4 to 19, between 2001 and 2007. Of these, 257 were getting psychotropics for severe problems for the first time, and 15 others refused the drugs but agreed to be seen by a doctor. The drugs were olanzapine (Zyprexa), quetiapine (Seroquel), risperidone (Risperdal) or aripiprazole (Abilify). Restricting the study to first-timers eliminated problems encountered in earlier studies.

After a median follow-up period of nearly 11 weeks, these patients had gained 10 to 19 pounds on average, depending on the drug. Kids on Zyprexa gained the most, on average, while those taking Abilify gained the least. The 15 patients who had refused drug treatment gained less than one pound on average during the monitoring period.

The pace of weight gain seems to level off over time, Correll says, but further study will be needed to clarify that trend.

“This is a really good study of relatively short-term effects,” says Christopher Varley, a child psychiatrist at the University of Washington School of Medicine and Seattle Children’s Hospital. But longer-term data are needed, he says, “because you never really treat a kid with one of these conditions for only 12 weeks—it’s more like six to nine months or a year or two.”

Correll’s team intends to monitor as many of the patients as possible over a longer time period.

Child psychiatrist Linmarie Sikich of the University of North Carolina at Chapel Hill School of Medicine says that she and her colleagues have seen many patients lose weight after coming off these drugs. So far, researchers don’t have enough data to clarify why some patients lose the weight and others don’t, she says.

The biological mechanism underlying the weight gain also remains obscure, Varley says. But some effects are evident, such as carbohydrate cravings. “The appetite of these youngsters dramatically goes up,” he says. At the same time, the drugs have a mild sedative effect. “They’re not out running around, expending calories.”

Sikich says some evidence suggests that the drugs may block the body’s satiety signal.

Meanwhile, patients in this study taking Zyprexa showed increased LDL cholesterol and triglycerides, types of fat in the blood. Patients getting Seroquel also had higher triglycerides. The other drugs showed little change in these metabolic markers.

“This does leave a difficult decision, but I think we’re getting increasing guidance,” Sikich says. Clinicians would prefer to prescribe the drugs with the mildest side effects, she notes.

While all four drugs are cleared for adults, the U.S. Food and Drug Administration has specifically approved only Abilify and Risperdal for pediatric use thus far. Earlier this year, a panel of experts recommended that the FDA approve all four drugs for certain severe psychiatric problems in children. The regulatory body has yet to rule on that.

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Court Doccuments Reveal Psych Drugs Misused on Children

October 28, 2009

Natural News

By David Gutierrez

Internal documents acquired as part of a series of lawsuits show that pharmaceutical giant AstraZeneca planned as early as 2001 to market its antipsychotic drug Seroquel for uses not approved by the FDA.

Under U.S. law, drug makers are prohibited for marketing their drug for any use not approved by the FDA. Doctors are still permitted to prescribe drugs, however, for any use they wish.

Seroquel (generic name quetiapine) was approved for the treatment of psychotic disorders in adults in 1997. In 2001, the FDA extended this approval to cover schizophrenia. In 2004, it was approved for use of bipolar mania, and in 2006 it was approved for bipolar disorder.

Yet AstraZeneca is now the defendant in thousands of lawsuits claiming, among other allegations, that the company actively marketed the drug for use in children and adolescents, and also sought to market it as a treatment for dementia in the elderly.

In some of the retrieved documents, AstraZeneca employees and employees of a consulting firm hired by the company reference plans to “broaden Seroquel use on- and off-label,” specifically mentioning adolescents and people suffering from Alzheimer’s or Parkinson’s disease. Areas where the company could promote this use are listed, including sales calls and meetings with medical professionals or patient advocacy groups.

In a 2001 public relations plan, the company says that it seeks to “encourage and support [Seroquel] use outside schizophrenia into a broad range of other patient populations including bipolar disorder and the elderly.” The document calls for “aggressive market penetration” of the drug in the demographics of adolescents, the elderly and bipolar patients.

This came five years before the drug’s approval as a treatment for bipolar disorder. To date, the drug has never been approved for use in children, adolescents or patients with dementia or Parkinson’s disease.

AstraZeneca has applied for FDA approval to use Seroquel as a treatment for adolescent schizophrenia and acute bipolar mania in children and adolescents. No antipsychotic drugs have yet been approved for use in children, as there is nearly no evidence on their safety or effectiveness in that population.

The Seroquel lawsuits are only one of a number of recent scandals in which pharmaceutical giants have been accused of illegally promoting off-label drug use. Eli Lilly recently agreed to pay a $1.42 billion settlement to end charges that it promoted its antipsychotic Zyprexa (olanzapine) off-label.

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