More pharmaceuticals have been linked to a meningitis outbreak which has sickened 214 people killed 15.
New England Compounding Center, NECC, is the pharmaceutical company at the center of the outbreak and is cooperating with the FDA and the CDC advising doctors and surgeons to contact patients who have come in contact with drugs which may be responsible for the spread of meningitis.
“All-natural geranium extract”, only sounds healthy.
However, according to a new study, it’s anything but natural—and it might even be lethal.
Makers of workout and weight-loss products—think diet pills and sports drinks—containing DMAA (1,3-dimethylamylamine) tout it as a natural stimulant, made from geranium plants, that can boost athletic performance. But new research from Daniel Armstrong, PhD, a professor at the University of Texas at Arlington, finds that DMAA is actually a synthetic substance—one that the FDA has received 42 complaints about regarding adverse effects, such as cardiac and psychiatric disorders, as well as death.
In April 2012, the FDA sent warning letters to 10 manufacturers that products containing DMAA are now considered to be “new dietary ingredients” and must meet FD guidelines for safety.
Even if the manufacturers had submitted safety documentation, the FDA probably wouldn’t have accepted it in light of clear evidence to the contrary.
There have been two deaths of U.S. soldiers reported—as well as multiple reports of kidney and liver failure—which led to the Department of Defense banning anything containing DMAA in military bases in 2012.
The FDA has finally publicly recognized the dangers of BPA in plastics and the environment.
The ban is based on concerns voiced by the American Chemistry Council which encouraged the FDA to phase out use of BPA in these particular products.
This was designed in part to counter years of negative publicity from consumer groups.
The dangers of BPA in the environment and their effect on all humans have raised red flags for years.
Previous research in animals has associated BPA exposure to disruptions in reproductive and nervous-system development in babies, but the FDA has long maintained that such findings cannot be applied to humans. Other observational studies in humans have associated prenatal exposure to the chemical with behavior problems and childhood asthma. Just this week, the journal Pediatrics published a study linking BPA in dental fillings to problems like depression and anxiety in kids.
Some 96% of pregnant women have measurable levels of BPA, according to a 2011 study by University of California, San Francisco, researchers; in fact, data show that nearly every American has traces of BPA in their urine from exposure to food and beverage packaging.
For now, the federal government maintains that BPA does not harm humans, but it is spending $30 million on its own studies to assess the chemical’s health effects on humans.
The FDA has approved Qsymia for use today by those who are obese, with a BMI of 30 or more, or for those who have a BMI of 27 with weight related illness.
The history of weight loss pills has been fraught with law suits due to life threatening side affects and prescription abuse by physicians and patients.
The major problem with weight loss drugs is that they don’t address the underlying causes of weight gain such as the psychological component of over eating and the food itself.
There is wide ranging debate regarding the way certain processed and scientifically engineered foodstuffs react with human physiology and metabolism.
Until we confront these two major issues surrounding food it will be difficult to solve America’s obesity epidemic with a pill.
“Given the literally insatiable appetite of doctors and patients for new drugs as a quick fix for obesity, there is every reason to believe that, if approved, a combination like this, will be used by millions, over long periods of time far beyond its labeling indications. Because of a long list of safety reasons, this drug should not be approved,” the group’s Dr. Sidney Wolfe told the FDA advisory panel in 2010.
Vivus, the company that makes Qsymia, hopes it will be a safer successor to the notorious and now banned “fen-phen” diet cocktail. Fen-phen combined fenfluramine and phentermine — one of the two drugs in Qsymia — but it damaged the heart in some cases and caused a condition in some patients called pulmonary hypertension, which causes fluid to build up in the chest, bringing a feeling of breathlessness.
The FDA used spy software designed to help employers monitor workers and capture screen images from the government laptops used when they working from home.
A detailed surveillance, of the five scientists in question, included monitoring of keystrokes, personal e-mails, documents on personal thumb drives and line by line messages which were captured by the agency.
A dispute lasting years between the scientists and their bosses at the F.D.A. fueled the intense scrutiny of the information.
The scientists’ claims that faulty review procedures at the agency had led to the approval of medical imaging devices for mammograms and colonoscopies that exposed patients to dangerous levels of radiation is at the center of this investigation.
Moving to quell what one memorandum called the “collaboration” of the F.D.A.’s opponents, the surveillance operation identified 21 agency employees, Congressional officials, outside medical researchers and journalists thought to be working together to put out negative and “defamatory” information about the agency.
F.D.A. officials defended the surveillance operation, saying that the computer monitoring was limited to the five scientists suspected of leaking confidential information about the safety and design of medical devices.
It has been 13 years since the FDA has approved a new drug for weight loss.
Belviq, the Arena Pharmaceuticals drug which also goes by the generic name lorcaserin, is one of three new potential weight-loss treatments to be approved.
The drug works by activating a receptor in the brain that may help a person eat less and feel full after eating smaller amounts of food.
It is approved for use in obese adults with a body mass index or BMI of 30 or greater and in overweight adults with a BMI of 27 or greater if they have at least one weight-related condition such as high blood pressure, type 2 diabetes or high cholesterol. For example, a 5-foot-7 woman who weighed 192 pounds would have a BMI of 30.
Patients who do not lose 5 percent of their body weight within 12 weeks of taking the pill will be advised to discontinue use of the drug.
It is important that patients achieve “clinically meaningful weight loss” as cardiovascular risks including heart attack and stroke may be a consideration.
Michael M. Landa, director of the Center for Food Safety and Applied Nutrition at the F.D.A., denied the petition, saying that the term “sugar” is used only for food “that is solid, dried and crystallized.”
“HFCS is an aqueous solution sweetener derived from corn after enzymatic hydrolysis of cornstarch, followed by enzymatic conversion of glucose (dextrose) to fructose,” the letter stated. “Thus, the use of the term ‘sugar’ to describe HFCS, a product that is a syrup, would not accurately identify or describe the basic nature of the food or its characterizing properties.”
The Corn Refiners Association is afraid that consumers will avoid the product, which has received a bad reputation, under the pretext of “false information”, namely that corn syrup is natural and is the same as sugar.
The fact is that it is NOT natural , it is manufactured in a lab and can harm to people who can not properly metabolize the ingredient.
And further, to argue that HFCS is the same as sugar only calls into question the efficacy of sugar in the human diet.
There are many who would postulate that there already exists an overabundance of sugar which is causing obesity and Type 2 diabetes in epidemic proportions.
The news has been confusing in the past but the FDA is offering new rules to ensure that we get the protection we need and the protection level we pay for.
The FDA announced that it is giving sunscreen manufactures six months to comply with regulations meaning that the changes won’t be in stores this summer.
Key fixes: Sunscreens will be labeled “water resistant” (as opposed to waterproof or sweatproof); they can no longer be called “sunblocks” (as it overstates their effectiveness); and they can no longer claim to provide instant sun protection or to last more than two hours without reapplication.
On top of that, sunscreens can be labeled “broad spectrum” only if they protect equally against UVB (the main culprit of skin cancer) and UVA rays, which cause aging.
The panelists decided that the benefits of the weight loss drug outweigh the risks for severely obese patients.
The panel included specialists in obesity and diabetes, pediatric endocrinologists, cardiologists and toxicologists.
According to Arena Pharmaceuticals, which developed the drug, Lorqess “behaves as an appetite suppressant which helps patients lose weight by essentially causing them to feel less hunger sensations.”
Bisphenol A is toxic and dangerous and so pervasive that it shows up in the urine of 93% of Americans over the age of 6 years.
The ubiquitous abundance of this organic compound is found in everything from the lining of cans to water bottles and a myriad of plastic products used by consumers everyday.
Aside from obesity concerns of BPA contamination include cancers and autoimmune diseases.
“During the development of the fetus, BPA exposure alters the development of stem cells,” vom Saal, a professor at the University of Missouri, said. “Think of it as tripping a switch in the DNA. BPA turns out to be a major factor in the number of fat cells that a person will have later in life.”
Critics label BPA an “endocrine disruptor” that acts like synthetic estrogen and link it to a wide range of ailments, including cancer. But its scientific defenders — as well as regulatory agencies in the United States, Australia, the European Union, Japan, and New Zealand — say there is no evidence that the minuscule exposure that consumers receive poses a health risk.
Although FDA approved the agency now recognizes “reason for concern” for the affects on fetuses and children.
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