Hydroxycut products are recalled

The Food and Drug Administration has issued a warning to consumers to stop using Hydroxycut dietary supplements because some have been linked to serious liver injuries, with one death reported to the agency.

Iovate Health Sciences Inc. is recalling its Hydroxycut products from the market. The popular, heavily advertised supplements promise weight loss and include such products as Max Drink Packets, Caffeine-free Rapid Release Caplets, and Max Aqua Shed. Not part of the recall are Hydroxycut Cleanse and Hoodia products. The recalled products contain several ingredients, among them herbal extracts, although the FDA said it’s not sure which ingredients or dosages could be causing the problems. Unused products should be returned to where they were purchased.

In all, one death due to liver failure was reported to the FDA, plus 23 instances of severe health problems including jaundice, elevated liver enzymes, liver damage (requiring a liver transplant), seizures and cardiovascular disorders. Liver injury symptoms include jaundice, brown urine, excessive fatigue, stomach or abdominal pain, and nausea.

Although the FDA says that bad reactions are rare, anyone using the products should stop immediately. Dr. Linda Katz, the interim chief medical officer of the agency's Center for Food Safety and Applied Nutrition, said those experiencing symptoms should check with their doctor.

-- Jeannine Stein

FDA should step up monitoring of dietary supplements, GAO says

The Government Accountability Office today released a report urging improvements in how the Food and Drug Administration monitors and governs dietary supplements.

"Although FDA has taken some actions when foods contain unsafe dietary ingredients, certain factors may allow potentially unsafe products to reach consumers," the report states.

Vitamins, minerals and herbs constituted a $24.7 billion business in the United States in 2007, the report notes. However, concerns have been raised about product reliability and the FDA's ability to monitor product safety. In recent years, the FDA has made some progress to protect the public from unsafe products. For example, the FDA mandates the reporting of serious adverse events related to supplements. But the GAO report found a long list of flaws in the FDA's approach. For example, the GAO said:

• Some companies that make herbal products are not required to identify themselves as dietary supplement companies.
• Some companies are not required to provide the FDA with information on the products they sell.
• Manufacturers are required to report only serious adverse events, not mild or moderate problems.
• The FDA has few resources for oversight.
• The FDA has insufficient ability to remove a product from the market.

The report recommends that the U.S. Department of Health and Human Services direct the FDA commissioner to seek additional regulatory authority over supplement manufacturers. Manufacturers should be required to produce a list of their products, their labels and report all adverse events. The FDA should also clarify when an ingredient is consider "new" and what evidence is needed to document the safety of new ingredients.

-- Shari Roan

Photo credit: Luis Sinco / Los Angeles Times

Folic acid and B vitamins are OK, but they're not cancer fighters

Take those folic acid, vitamin B6 and vitamin B12 supplements every day if you want, just don't expect them to lower your cancer risk.

Researchers at Brigham and Women's Hospital and Harvard Medical School analyzed data from a study of 5,442 women age 42 and older who were at high risk of cardiovascular disease and who had taken a daily combination of the three supplments or a placebo for more than seven years.

The supplements are crucial in DNA synthesis, repair and general functioning, which suggests higher levels of them could lower cancer risk. Some observational studies had supported this notion. But the research has been far from definitive, with one study even suggesting a negative effect.

So the researchers went looking through data from the Women's Antioxidant and Folic Acid Cardiovascular Study, which assessed effects of the supplements on cardiovascular disease. This time, the analysis was meant to find differences in breast cancer or invasive cancer among participants. And it turned up ... not much.

Specifically, 187 women in the supplement group developed cancer, compared to 192 in the placebo group, a difference not considered significant.

Said the researchers in their conclusion, published Nov. 5 in the Journal of the American Medical Assn.:

"Treatment with combined folic acid, vitamin B6 and vitamin B12 provided neither beneficial nor harmful effects on overall risk of total cancer, breast cancer or deaths from cancer among women at high risk for CVD."

For what it's worth, the study assessing the supplements' effects on cardiovascular disease didn't find much either.

-- Tami Dennis

Photo: Folic acid is found in leafy greens, eggs and beans -- and supplements. Many grain products are now fortified with it as well. Credit: Carlos Chavez / Los Angeles Times

Hold on a minute, Bayer...

Two new Bayer products, both containing good ol' aspirin plus a nifty supplement, beckon consumers with suggestions that they can reduce the risk of heart disease. One of them also says it can help fight osteoporosis.

Such products, and the claims about them, appear to have gone too far. The Food and Drug Administration politely pointed out today that the one-tablet combos amount to new drugs and, as such, require the agency's approval before they can be sold or marketed in such a way. That approval has not been granted.

So what the agency has granted is warning letters, posted online, alleging illegal marketing and calling the products themselves unlawful. At issue are Bayer Aspirin with Heart Advantage, which contains aspirin and phytosterols, and Bayer Women's Low Dose Aspirin + Calcium, which contains aspirin and calcium.

Says the agency's news release:

"The FDA considers these products new drugs and thus they must undergo the FDA's drug approval process," said Mike Chappell, the FDA's acting associate commissioner for regulatory affairs. "The FDA will take enforcement action against manufacturers found to be violating the law or attempting to circumvent the drug approval process."

Such warning letters are not exceptional, but they do suggest some response is needed. Beyond taking issue with the marketing, the agency also says the labels' directions for use are more than a little problematic.

The website for Bayer Aspirin with Heart Advantage says: "Phytosterols, a natural plant-based supplement also known as plant sterols, are clinically proven to lower bad cholesterol, which may help reduce the risk of heart disease." Here's its warning letter.

The website for Bayer Women's Aspirin + Calcium says: "The product addresses two major health threats facing American women today -- heart disease and osteoporosis. Bayer Women's Aspirin plus Calcium combines 81 mg of calcium -- the lowest strength available that can provide the lifesaving benefits of aspirin -- with as much calcium as in an 8 oz glass of milk (300 mg elemental calcium) to help reduce the risk of osteoporosis." Here's its warning letter.

A company spokeswoman told Bloomberg News that it stands behind the marketing -- but that it would review the FDA's letters.

For what it's worth, both Bayer pages point out, in bold type: "Aspirin is not appropriate for everyone, so be sure to talk to your doctor before you begin or modify an aspirin regimen."

The American Heart Assn. is a firm supporter of aspirin use in heart attack and stroke prevention. And here's some useful information from U.S. News & World Report on aspirin.

But the FDA wants to weigh in on the combo -- and the marketing. 

-- Tami Dennis

Vitamin E, selenium fail to prevent prostate cancer

Vitamin E and selenium supplements, either taken independently or together, do not reduce a man's chances of developing prostate cancer, and may even heighten his risks, a federally funded study has found.

A seven-year trial involving more than 35,000 subjects and conducted at 400 sites around the United States was suspended this month, after researchers began tallying the effects and found, at best, no benefit and at worst, signs of trouble. Participants were told to stop taking their supplements and assured that their health would be monitored for roughly the next three years.

Researchers found a slightly elevated risk of prostate cancer in subjects taking only Vitamin E and a small increased risk of developing diabetes in men taking only selenium. The National Institutes of Health, which funded the study, cautioned that those small effects may have been due to chance. As they comb the evidence, the researchers should learn more about the relationship.

The preliminary results of what is known as the SELECT trial are a major disappointment to those who had hoped that an inexpensive, widely available dietary supplement might prove powerful in the prevention of cancer. Previous studies had suggested that selenium and Vitamin E, taken alone or together, might decrease the risk of developing prostate cancer by 60% and 30%, respectively.

But the latest study is not the first trial of supplements' cancer-prevention properties to end in disappointment: Studies completed in the 1990s found that beta-carotene supplementation failed to prevent lung cancer, and in fact appeared to increase the odds that male smokers would develop the disease.

In other clinical trials, researchers are exploring whether lycopene, a plant-based substance, might drive down the risk of prostate cancer for men. Drugs being studied as possible prostate cancer preventives include the anabolic steroid toremifene, the enlarged-prostate treatment dutasteride, and finasteride, which is widely prescribed for enlarged prostate and hair loss.

--Melissa Healy

St. John's wort helps with depression -- especially if you're German

It works. It doesn't. It works. It doesn't. That's health research news for you. One item that gives me whiplash, is the effectiveness -- or not -- of the herb St. John's wort for relief of depression.

Here, for example, is what the National Institutes of Health says: "There is some scientific evidence that St. John's wort is useful for treating mild to moderate depression. However, two large studies, one sponsored by NCCAM [the National Center for Complementary and Alternative Medicine], showed that the herb was no more effective than placebo in treating major depression of moderate severity."

The University of Maryland Medical Center says that, "In numerous studies, St. John's wort has been effective in reducing depressive symptoms in those with mild to moderate but not severe (called major) depression."

So one site says the herb's effective in treating moderately severe major depression and the other says it's not effective for major depression but is effective for moderate and mild depression that would not be defined as major. 

Argh! Argh! At this point one starts to wonder if the most confusing thing about these studies is the definition of depression. (According to Medline, "major depression" is diagnosed when five or more symptoms of depression persist for more than two weeks -- symptoms including feeling sad, hopeless, worthless or pessimistic.)

Perhaps it helps to not get overly hung up on such definitions. In any case, our friends from the Cochrane Collaboration have just weighed in with a Systematic Review that evaluated 29 trials on the topic and concluded the following: The herb does appear effective for major depression, at least mild and moderate versions thereof -- and, in fact, is as effective as antidepressants (and slightly better than placebos, suggesting that none of these items appear to be miracle-workers, antidepressants included).

But ... for some perplexing reason, trials conducted in German-speaking countries had better results than trials conducted in other countries. What the ?! Should melancholy, herb-chugging types all quickly move to Germany?

"This difference could be due to the inclusion of patients with slightly different types of depression," the review authors write. Use of the herb is quite accepted in such countries, which might influence what kind of patient enters a trial. "But it cannot be ruled out that some smaller studies from German-speaking countries were flawed and reported overoptimistic results."

The authors end their report with two reminders -- to tell your physician if you're taking the herb since it might interact with other meds, and bear in mind that supplements can vary a lot in quality.

-- Rosie Mestel   

Photo: A worker harvests St. John's wort, with bright yellow flowers, at a farm in Canon City, Colo. Credit: Wally Skalij / Los Angeles Times

Nestle selling high-end beauty drink

The same company that brought you Butterfingers and chocolate morsels is now selling a fancy-shmancy, nutritional beauty drink. Nestle, the world's largest food and beverage company, has begun selling the product, Glowelle, at Neiman Marcus and Bergdorf Goodman.

The drink, which comes in two flavors, can be found in the cosmetics departments of the stores. According to Nestle, Glowelle is a nutritional supplement that protects and hydrates the inner and outer layers of the skin. The product contains antioxidants, vitamins, phytonutrients and botanical and fruit extracts. All the ingredients are meant to nourish the skin. Nestle is not the first company to market nutritional supplements for skin care. Cosmetics giants such as Murad and Perricone sell dietary supplements for skin health. But it will be interesting to see if this product catches on.

There are a couple of downsides.  It costs a whopping $7 per bottle or $40 for a week's supply. The blogger realself.com noted: "I'm all for drinkable anti-aging, but at $7.00/bottle, Glowelle would make that Starbucks habit seem pretty tame financially."

Moreover, is there any scientific proof that nutritional supplements, either in pill or liquid form, really make a difference in the skin's appearance? Show me one study, please, that this stuff works.

-- Shari Roan

Photo credit: Nestle USA 

Black cohosh and liver problems

Ever since the Women's Health Initiative halted a study of hormone replacement therapy in 2002 because of increased risk of breast cancer and heart disease, menopausal women have struggled with what to do about hot flashes. Many have turned to the herbal remedy, black cohosh, despite a lack of definitive evidence that it works.

There's no definitive evidence that it causes any harm, either, although there have been anecdotal reports of liver damage, hepatitis and even one report of the death of a woman as she awaited a liver transplant after taking the remedy.

Now, a committee of the U.S. Pharmacopeia, a nongovernmental organization that sets standards for food ingredients and dietary supplements, has recommended cautionary labeling for black cohosh because of the possibility of liver damage.

Its report, in the recent issue of the journal Menopause, is a change from the organization's 2002 report, which called for no such labeling. An editorial points out that, because of the great variability in the contents of largely unregulated herbal remedies, science will likely have difficulty proving or disproving the danger of black cohosh.

"We must also be willing to state without shame that there is much we don't know about black cohosh," according to the editorial.

The committee also recommends that women consult a physician before using the remedy if they've ever had liver disease, or immediately if they develop symptoms including dark urine, jaundice or abdominal pain after taking it.

-- Susan Brink