Consumers should not use Miracle II Neutralizer and Miracle II Neutralizer Gel Drug products, which are not approved and are contaminated with bacteria that can cause severe infections, the U.S. Food and Drug Administration warned Tuesday.
The products, made by Tedco Inc. of West Monroe, La., pose the greatest risk to children, the elderly, and people with weakened immune systems, the FDA said.
Miracle II Neutralizer is sold as an eye-care product, but should never be used in the eyes because it is not sterile, the FDA said. The product is also marketed for other uses, including treatment of AIDS, cancer, Crohn's disease, dermatitis, diaper rash, diabetes, ear ache, hemorrhoids, hives, gout, psoriasis, and skin cancer.
Miracle II Neutralizer Gel is marketed for many of the same uses. Neither product has FDA approval for any of those uses.
"We will not tolerate the marketing of products that use deceptive and untruthful claims to lure consumers into potentially dangerous situations," Margaret O'K. Glavin, the FDA's associate commissioner for regulatory affairs, said in a prepared statement.
"We consider it a significant public health hazard when consumers are deliberately deceived into using potentially dangerous products that promise health benefits but deliver only the risk of harm," she said.
Early Detection, Treatment Emphasized for Peripheral Artery Disease
New guidelines that promote the early detection and treatment of peripheral arterial disease (PAD) were released Tuesday by the American Heart Association and the American College of Cardiology.
PAD, which affects about 12 million Americans, includes diseases of the arteries that supply blood to the arteries outside the heart. These include arteries that supply the legs, feet, kidneys and intestines.
The new guidelines include:
Recommended questions and observations that can uncover hidden signs of PAD. Clinical clues that a patient may have renal artery stenosis, a narrowing of the arteries that supply blood to the kidneys and a possible cause of poorly controlled high blood pressure or kidney failure. Recommendations on when an aneurysm -- a weakening and bulging of an arterial wall -- should be treated with surgery or catheterization-based therapy or when "watchful waiting" is the best course. A critical analysis of the strengths and weaknesses of vascular imaging tests and other diagnostic methods. An emphasis on treatment choices, including the role of exercise, diet, smoking cessation, and medications, along with an objective review of the benefits and drawbacks of surgical and catheter-based treatments. "These guidelines provide a concise diagnostic and treatment guidebook for patients suffering from PAD and for physicians, physicians assistants, nurse practitioners, and nurses who are now offering care to treat them," Dr. Alan T. Hirsch, chairman of the guidelines writing committee, said in a prepared statement.
Molecule Could Offer Down Syndrome Treatment Target
A molecule that may offer a target for treatment of mental impairment in people with Down Syndrome has been identified by scientists at the Institute of Psychiatry at King's College London, England.
They found that people with Down Syndrome have higher levels of the molecule myo-inositol in their brains than healthy people, and that higher levels of the molecule are associated with lower levels of intellectual ability, BBC News reported.
The study authors said they also suspect that high levels of the molecule may predispose people with Down Syndrome to early-onset Alzheimer's disease. It's already known that myo-inositol promotes formation of amyloid plaques associated with Alzheimer's disease.
The findings appear in the journal Archives of General Psychiatry.
FDA Official Criticizes Agency Over Suspension
A drug safety officer with the U.S. Food and Drug Administration said Monday that her career and reputation were harmed when she was suspended from reviewing a dog heartworm drug because the drug's maker complained about her.
The action against Dr. Nancy Hampshire was taken after the FDA received a complaint from Wyeth that she had a relationship with an Internet veterinary pharmacy that offered products competing with the drug, ProHeart 6, The New York Times reported.
Hampshire was eventually cleared of any wrongdoing. But, the Times reported, she's angry that FDA officials didn't inform her of the accusations and didn't offer her the chance to explain herself before suspending her, a move that she said damaged her career.
"Everybody jumped to the conclusion that I was guilty before they knew the answers, and no public apology was ever made," Hampshire told the newspaper.
In 2003, she raised concerns about ProHeart 6, which was later linked with the deaths of about 500 dogs and sickness in 5,000 other dogs. Wyeth withdrew ProHeart 6 from the market in 2004, after being pressured to do so by the FDA.
As for the FDA's action against Hampshire, an agency spokesperson said the FDA acted properly and considers the matter concluded, the Times reported.
U.S. Nursing Home Quality Stagnant: Report
Nursing home quality in the United States has stagnated, says a ratings report released Tuesday by HealthGrades, a health-care ratings organization.
The report on 15,375 Medicare/Medicaid-certified nursing homes found that deficiencies causing actual harm to nursing home residents declined from 7 percent to 6.5 percent from 2003 to 2004, while patient abuse remained stable at 17 percent of complaints.
Overall, the number of deficiencies per nursing home declined 2 percent from 2003 to 2004.
"We're not seeing the declines in actual harm to the nation's 1.6 million nursing home residents that we should," Dr. Samantha Collier, vice president of medical affairs for HealthGrades, said in a prepared statement.
"But we did discover some interesting facts that will help people make a smarter decision, including the finding that the top 10 nursing homes in each state tend to have nearly half as many beds as the worst 10 in each state -- something that everyone should think about when choosing a nursing home," Collier added.
School Bake Sales Linked to Student Obesity
They're a cherished tradition, but school bake sales may contribute to childhood weight problems, according to new University of Minnesota research.
The study of 3,088 eighth-grade students at 16 schools found that there were more overweight students at schools that ran bake sales and allowed teachers to use candy, donuts and other unhealthy treats to reward students, the Associated Press reported.
The study doesn't actually prove that such food practices contribute to student obesity, but there appears to be a connection, said study lead author Martha Kubik.
"I think we all have to step back and look at what we're doing to contribute to practices that might not support children developing healthy dietary behavior," Kubik told the AP.
The study findings were published Monday in the journal Archives of Pediatrics and Adolescent Medicine.
Health Tip: Double Vision Has Many Causes
Double vision occurs when a person sees two images of the same object, sometimes as completely separate items and sometimes as an overlapping image. This can be caused by a multitude of conditions, such as diabetes, cataracts, brain tumors and dry eyes.
The University of Iowa warns that many types of double vision can't be prevented, but safety precautions can be taken. Some of these include wearing safety goggles and headgear for sports and high-risk occupations. Those with the condition should also always wear seatbelts while driving. Diabetics should keep their sugars under control to decrease the risk of developing double vision.
Patients with double vision can usually do eye exercises or consider surgical straightening of the eye to treat the condition.
Health Tip: Want Those Pearly Whites Brighter?
Everyone wants a brighter smile, but with all the new teeth whitening products on the market, it's hard to know your options.
The American Dental Association (ADA) says some approaches to teeth whitening include in-office bleaching, at-home bleaching and whitening toothpastes.
Your dentist may suggest in-office bleaching, which may require more than one visit taking 30 minutes to an hour. During this procedure, the dentist will apply a bleaching agent to the teeth, and a special light may be used to enhance the action of the agent.
Bleaching solutions that you can use at home include peroxide that bleaches your tooth enamel. These kits usually come in gel form, but usage regimens vary.
Toothpastes are also effective for removing surface stains, but whitening toothpastes have special chemical agents that provide additional stain removal. These products do not alter the intrinsic color of teeth.
Regardless of the procedure you use, it is recommended you speak with your dentist beforehand, and be sure to look for products with the ADA Seal of Acceptance.
Food Fact: Rejoice, cocoa nuts!
Choose the right chocolate treat, and you can have all the flavor you savor with next-to-no fat. Three tablespoons of cocoa powder (the equivalent of 1 oz. of chocolate in flavor intensity) has only 1.5 grams of fat. By comparison, a 1-oz. square of premium unsweetened chocolate has 16 grams of fat. In addition, cocoa's main fat, stearic acid, may be heart-healthy. Our bodies convert it to a monounsaturated fat. Limit any chocolate that adds "hydrogenated oils," which add cholesterol-raising fats to the mix.
Fitness Tip of the day: Muscled out?
Inactive adults over age 30 lose about 3 - 5% of muscle tissue every 10 years; here's what you can do. Go to the weight room. Strength training prevents the reduction in muscle tissue that causes the body metabolism to slow and makes the bones more vulnerable to conditions like osteoporosis.
FAQ of the day: Does variety in exercise matter?
Miavita Scientific Advisor Steve Blair of the Cooper Institute for Aerobic Research says: I advise exercisers to engage in at least one aerobic activity and do some resistance exercise for musculoskeletal fitness, along with stretching to maintain joint flexibility. If there's one routine you like to do again and again in each category, that's OK. If you like to do different aerobic and musculoskeletal exercises at different times, all the better. What really counts is to find the exercise program you like enough to stick with over time. Keep it up, and you'll reap the incredible benefits that come from a fit, active way of life.