The U.S. Food and Drug Administration has a reputation as one of the strictest regulators in the world. But in many ways, that distinction is undeserved, a leading pharmaceutical expert tells Newsmax Health. "Just listen to TV commercials about prescription drugs. Read full...
People use various ways to lose weight fast. If you are one of those people who like to turn to “fat burners” like thermogenic supplements such as OxyElite Pro to help lose weight you might end up having not only intense side effects, but also liver failure and acute hepatitis!
This month Hawaii health officials asked retailers to take OxyElite Pro off their shelves. It’s a common weight loss supplement that claims to burn fat. But the issue is that it contains dimethylamylamine (DMAA) – an illegal stimulant which also goes by the names methylhexamine and geranium extract.
Risks using this supplement include liver failure and acute hepatitis. In Hawaii, two people using it required liver transplants, and one patient died.
When used with caffeine DMAA also increases heart attack risk.
Several supplement makers were asked this summer by the FDA to remove DMAA from their formulas and most of them complied. But who knows how many are still sitting on the store shelves right now?
So, if you or a family member is currently using a product that claims to blast or burn fat, check the label immediately, and if it contains DMAA, stop using it right away.
Also on October 8, 2013, the U.S. Food and Drug Administration (FDA) posted a statement on its website advising consumers of an ongoing investigation related to a growing number of reports of acute non-viral hepatitis in Hawaii and further advised consumers not to use the dietary supplement product labeled OxyElite Pro while the investigation is still ongoing. Today the FDA is advising consumers not to use an additional product produced by USP Labs labeled VERSA-1.
FDA advises consumers not to use any dietary supplements labeled OxyElite Pro or VERSA-1 because these products contain an ingredient, aegeline, for which the manufacturer has not provided adequate evidence of safety.
In a warning letter issued to USP Labs LLC of Dallas Texas on October 11, 2013, the FDA informed the company that the dietary supplements OxyElite Pro and VERSA-1 are deemed to be adulterated, and that failure to immediately cease distribution of these products may result in enforcement action by the FDA.
The warning letter states that the products are deemed adulterated because they contain a new dietary ingredient (an ingredient not previously present in the food supply, and for which there is no history of use or other evidence of safety when used as suggested in the labeling) which lacks adequate information to provide reasonable assurance of safety.
Specifically, USP Labs failed to provide the FDA with evidence, as required by law, that aegeline, also referred to as N-[2-hydroxy-2(4-methoxyphenyl) ethyl]-3-phenyl-2-propenamide, was safe for use in its dietary supplements.
Additionally, in the warning letter, the FDA relayed findings suggesting that a causal connection may exist between the use of a product labeled as OxyElite Pro and a number of liver illnesses reported in Hawaii.
The U.S. Food and Drug Administration (FDA) continues its investigation of acute hepatitis illnesses linked to products labeled OxyElite Pro.
The U.S. Food and Drug Administration (FDA) is investigating an increasing frequency of reports of serious and life-threatening blood clots and severe narrowing of blood vessels (arteries and veins) of patients taking the leukemia chemotherapy drug Iclusig (ponatinib).
Health care professionals should consider for each patient, whether the benefits of Iclusig treatment are likely to exceed the risks of treatment.
Patients taking Iclusig should seek immediate medical attention if they experience symptoms suggesting a heart attack such as chest pain or pressure, pain in their arms, back, neck or jaw, or shortness of breath; or symptoms of a stroke such as numbness or weakness on one side of the body, trouble talking, severe headache, or dizziness.
Pioglitazone, a drug used to treat type 2 diabetes, is associated with an increased risk of bladder cancer, according to findings from a study conducted by researchers from the Lady Davis Institute at the Jewish General Hospital, published in the British Medical Journal. The study was led by Dr. Laurent Azoulay of the Centre for Clinical Epidemiology, along with Hui Yin, Kristian B. Filion, Jonathan Assayag, Agnieszka Majdan, Michael N. Pollak, and Samy Suissa.
The FDA has issued a public health advisory due to the potential accidental mixing of over-the-counter (OTC) medications with prescription opioid painkillers at Novartis Consumer Health’s Endo Pharmaceuticals plant in Lincoln, Nebraska.