Researchers are expecting that combined drug therapies will help reduce heart disease-associated mortality. The ONTARGET trial looked at an angiotensin receptor blocker and ACE inhibitor (telmisartan and ramipril), traditionally anti-hypertensive drugs, in the treatment of cardiovascular disease in the absence of heart failure. The ONTARGET study findings were published in the April 10, 2008 issue of the New England Journal of Medicine.
The beverage Diet Coke Plus may have to be renamed and claims about vitamin and mineral content retracted due to FDA regulations about labeling. The Coca-Cola Company is being officially reprimanded by the Federal agency.
According to HealthDay, a healthier living news agency, Coca-Cola Co. has received a letter from the Food and Drug Administration admonishing them for fortifying a carbonated beverage, which is considered a snack item. Snack items are generally less healthy and fortifying them may lead consumers to believe they are healthy, when in fact no negative attributes have been removed.
The vitamins and minerals in Diet Coke Plus include magnesium and B-12, which benefit the immune system. The agency claims that this is not enough to warrant the company’s claims for the product.
The FDA has asked that the claim “plus” be removed from the label, but the company has stated that they have followed all regulations. A reply and appeal to the FDA is pending.
Read the FDA warning letter issued on Dec 10, 2008.
Normally the Food and Drug Administration doesn’t handle herbal supplements, but laboratory tests have shown the presence of unlisted ingredients or increased dosage in twenty-eight weight loss drugs sold as herbal or dietary supplements, thus avoiding FDA approval.
The FDA is warning that the undeclared ingredients are potentially dangerous. The agency is seeking a recall on the products and a crackdown on illegal sales.
The weight loss products are: Fatloss Slimming, 2 Day Diet, 3x Slimming Power, Japan Lingzhi 24 Hour Diet, 5x Imelda Perfect Slimming, 3 Day Diet, 7 Day Herbal Slim, 8 Factor Diet, 7 Diet Day/Night Formula, 999 Fitness Essence, Extrim Plus, GMP, 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, Somotrim, Superslim, TripleSlim, Zhen de Shou, and Venom Hyperdrive 3.0. Most of these products are manufactured in China.
Twenty-seven of the products were found to contain sibutramine, a Schedule IV controlled substance used in prescription obesity drugs that can result in high blood pressure, seizures, palpitations and heart beat irregularities, heart attack, or stroke. Some of the products contain 3x the recommended dose in prescription medications.
Phytoshape contained rimonabant, which has not been approved for use in the United States due to concerns about increased depression and suicide risks and other adverse neurological effects. It is known as Acomplia in Europe and sales were suspended in October. Rimonabant was linked with 5 deaths in June 2008 of the 720 adverse reactions over the previous 2 years.
Phenytoin, an anti-seizure medication, was found in trace amounts in 3x slimming power and Extrim Plus.
Phenolphthalein was found in eight of the products; it is a suspected carcinogen. It is also suspected of being genotoxic, meaning that it damages DNA. It was used in laxatives until 1999.
If you have used these products and experienced side effects, report them to the FDA’s MedWatch Adverse Event Reporting Program at http://www.fda.gov/medwatch/
For more information on these products and ingredients visit http://www.fda.gov/bbs/topics/NEWS/2008/NEW01933.html
Stevia, a sweetener from the leaf extract of the herb Stevia rebaudiana, has been an herbal supplement in the United States and artificial sweetener in Asia for decades, and a sweetener in South America for centuries.
Native to Paraguay, the Food and Drug Administration deemed stevia unsafe as a food additive in 1991, but recent research paints a different picture.
Both the Coca-Cola company and PepsiCo Inc are readying juice beverages sweetened with stevia for market, but might or might not wait for FDA approval. As long as stevia is indicated as an unapproved herbal supplement, it can legally be used.
There is speculation that Coca-Cola may go forward with their new Odwalla line prior to FDA approval, which according to scientists is almost certain.
The no-observed-adverse-effect level (NOAEL) for the taste-improving compound found in stevia (rebaudioside A), and left in new preparations to remove the licorice aftertaste of steviol, is 50,000 ppm in tested rats – implicating safety in humans.
There is also Truvia, a tabletop version of stevia from Cargill as an artificial sweetener.
The benefit of stevia is its lack of calories and that it doesn’t produce increased blood glucose levels, making it a perfect sweetener for diabetics. When these products hit the shelves is just a matter of time, whether this will be before or after FDA approval may affect public perception of both the companies and the agency.
A study published this week in the Journal of the American Medical Association reports on findings that brand name drugs are not more effective than generics for treating cardiovascular disease.
Because of financial concerns, many patients and doctors have been substituting brand name heart disease medications with their generic, and much cheaper, versions. A research group at Harvard Medical School in Boston compared studies that looked at the differences between generic and brand name meds between 1984 and August 2008.
Though the majority of expert editorials published during that time scoffed at the interchangeability of the drugs, research studies painted a different picture. For nine different classes of cardiovascular drugs, including beta-blockers, ACE inhibitors, and statins, there was 100% equivalence between generics and brand name drugs. Diuretics and calcium-channel blockers were an exception with 91 percent and 71 percent equivalence, respectively.
In 24 years, researchers have also not reported toxicity differences for generic and name brand warfarin.
Kesselheim et al note, “One explanation for this discordance between the data and editorial opinion is that commentaries may be more likely to highlight physicians' concerns based on anecdotal experience or other nonclinical trial settings. Another possible explanation is that the conclusions may be skewed by financial relationships of editorialists with brand-name pharmaceutical companies, which are not always disclosed. Approximately half of the trials in our sample (23/47, 49 percent), and nearly all of the editorials and commentaries, did not identify sources of funding.”
When seeking treatment for cardiovascular disease, including hypertension, expensive and well-advertised brand name medications do not offer a benefit over the less expensive generic formulations. In many cases, the generic is an identical chemical, though pharmaceutical companies attempt to patent everything from route of administration and pill coating to uses and dosage to prevent competitive generics from coming to market. This does not appear to have been successful for this particular type of drug, those for cardiovascular disease.
