FDA Approves “Eyelash Fertilizer”

The Food and Drug Administration (FDA) has approved the cosmetic use of an eye disease drug, allowing it to be sold as an eyelash enhancer.
Currently called Lumigan, the drug is produced by Allergan, the same pharmaceutical company responsible for Botox.
Lumigan was originally developed to treat glaucoma; however, researchers at Allergan discovered that patients who used the drug grew thicker, longer and darker eyelashes as a result. Allergan plans to call the product “Latisse” when marketing it cosmetically and expects the repurposed drug to generate about a half a billion dollars annually, the Associated Press reports.
An Allergan-conducted review tested 278 patients over the course of 4 months, intending to confirm that the drug increased thickness, length and darkness of lashes. A review of the study by the FDA showed that participants using the drug saw significant cosmetic changes, as compared to patients who received a placebo.
Last Wednesday, the FDA posted a review of the active ingredient in Lumigan on its Web site, preceding an independent review of the drug by medical experts, who voted on Friday to approve the drug for cosmetic purposes.
The panel of eye and skin specialists voted unanimously that the drug’s benefits outweighed its risks, according to WPVI, ABC’s Philadelphia affiliate. However, the panel also voted 5–3 that Allergan should be required to continue studies on certain patient groups.
Allergan says it will sell Latisse under a “risk management plan” meant to encourage doctors to explain and monitor possible side effects. The drug can lower intraocular eye pressure (which is why it’s used as a glaucoma drug) and may cause skin darkening in some users.
However, some doctors believe these safeguards may be not be sufficient to prevent potential abuse of the drug. Dr. Marijean Miller, ophthalmologist with the Children’s National Medical Center in Washington said, “I’m worried about off-label, nonsupervised use of this medication, and I’m concerned teenagers might use it three or four times a day instead of once.”

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FDA Panel to Scrutinize Safety of Some Asthma Treatments

A Food and Drug Administration panel is going to hold hearings this week to review the safety of a particular group of asthma medications after the agency’s staff recommended the drugs be prohibited for kids 18 and younger, Reuters reported.
The drugs in question are known as long-acting beta agonists (LABAs), and there are concerns that they are linked to “asthma-related deaths and asthma attacks,” the news service said.
The medications that could be affected are Foradil, which is made by Novartis AG and marketed in the United States by Schering-Plough Corp.; Advair and Serevent, which are both made by GlaxoSmithKline; and Symbicort, which is made by AstraZeneca.
Serevent and Foradil shouldn’t be used by people of any age with asthma, FDA staff has said.
According to the Philadelphia Inquirer, who cited FDA documents, kids ages four to 11 taking LABAs “appeared to be at greatest risk for complications than those taking older treatments.”
Long-acting beta agonists are inhaled along with steroids. LABAs keep constricted airways open for at least 12 hours, according to the Mayo Clinic, and reduce the use of what are known as “rescue medications” that quickly open up airways. LABAs are useful at night, and people who took them reported waking up less, and having a better quality of life than those who only took steroids for asthma, the clinic said.

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Ireland Initiates Massive Pork Recall

Ireland has issued an international recall of all pork products because they could contain dioxins, Voice of America News reported.
Prolonged exposure to “some forms” of dioxins can cause cancer, Reuters explained.
The recall applies to all Irish pork products produced since Sept. 1, 2008; up to 25 countries, including the United States, Russia, Japan, China, France and Germany, may have received contaminated pork.
Authorities say the pigs became contaminated after they ate tainted feed. The pig feed was produced at a plant that uses oil as a fuel to dry waste food and then turn it into animal feed. In this instance, a non-food grade oil was used instead of a food grade oil.
Ten of Ireland’s 500 pig farms, as well as nine farms in Northern Ireland, have used tainted feed. Veterinary officials stated that they will not allow pork processing to resume until all producers can demonstrate that their animal feed is safe.
Meanwhile, Ireland’s pork producers are bracing for the financial consequences of the recall. According to VOA News, the Irish pig industry “is worth more than $600 million per year.” The Belfast Telegraph reports approximately 100,000 pigs will be killed because of this scare.

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Link Between Postmenopausal Hormones, Cancer Risk Strengthened

A study involving hormone replacement therapy was stopped in 2002 after researchers saw a higher risk of breast cancer and heart trouble. Since then, the use of hormones for postmenopausal women has dropped by 70 percent.
Though at the time there was confusion over the safety and efficacy of hormones, new study results suggest that taking estrogen and progestin for a couple of years could raise the risk of developing breast cancer.
“Collectively, these new findings are likely to end any doubt that the risks outweigh the benefits for most women,” the Associated Press said.
During the same period that fewer women took hormones, the incidence of breast cancer also dropped.
The findings, from the federal Women’s Health Initiative, were presented over the weekend at the San Antonio Breast Cancer Symposium and involved tracking thousands of women.
After the Women’s Health Initiative stopped part of its study in 2002, recommendations were to prescribe the lowest-possible dose of hormones and only to alleviate the most severe of symptoms associated with menopause
Most of the women who are prescribed the hormones for a short period of time won’t get cancer from it, according to AP.
Another study presented at the symposium suggests that women who develop breast cancer after taking hormone replacement therapy “have a lower risk of dying from the disease,” HealthDay reported.
“We found that women who took hormone therapy before their diagnosis were more likely to be diagnosed with estrogen receptor-positive cancer, as well as having breast cancers that were more favorable in other ways, [such as being] smaller and detected at an earlier stage,” said Sarah Marshall, a senior statistician at University of California-Irvine and one of the study’s authors, according to HealthDay.

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8 Surprising Causes of Bad Breath

Has a friend or significant other gently hinted that your breath is, um, pungent? (Many halitosis sufferers can't tell.) Brushing and flossing more diligently may do the trick, and U.S. News's Sarah Baldauf offered other suggestions earlier this year. But a few more minutes at the sink won't always help, say experts. Here are eight causes of bad breath that may surprise you:
Medications. Saliva rinses away bacteria that foul the breath, and many drugs, among them antidepressants, diuretics, and even aspirin, can dry the mouth.
Bacteria. The stink-creating kind mostly hang out on the tongue, happily churning out gases as they munch on food particles and substances broken down from saliva, and multiply at night, when the salivary glands slow down (hence morning breath). Some people harbor more species of malodorous bacteria than others do, which may be why certain individuals are especially halitosis-prone. This month, a study in the Journal of Medical Microbiology suggests that H. pylori, the same bug that is often responsible for stomach ulcers, can cause bad breath and gum disease if it finds a home in the mouth.
Respiratory tract infections. Tooth and gum infections are recognized sources of bad breath. But so are bronchitis, sinusitis, and even a cold. RTIs break down tissue, starting a flow of cells and mucus that feed bacteria that create foul odors.
Skipping breakfast. Besides the well-established advantages to body and mind of having a good breakfast, it helps quell morning breath by stimulating saliva production and scrubbing bacteria from the tongue. (But lay off the sardine-onion sandwich.)
Diet. Foods high in protein or dairy products generate large amounts of amino acids, which are fodder for bacteria. A diet low in carbs burns stored fat, creating toxic-smelling ketones. And last year, researchers linked bad breath with obesity, although the basis is unclear.
Mouth breathing. Any condition that dries the tissues of the mouth, preventing saliva from washing away bacteria, encourages bad breath. Candidates include sleep apnea, snoring, and asthma.
Ongoing illnesses. A potent breath can signal particular diseases. Kidney failure produces a fishy smell and uncontrolled diabetes generates fruity fumes, for instance.
Alcohol. Heavy alcohol consumption also can dry out the mouth.

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11 Easy Ways to Load Up on Healthy Omega-3 Fats

Omega-3 fatty acids are essential to good health, but their benefits may be missed because the American diet is chock full of omega-6 fatty acids instead. (Learn more about the pros and cons of omega-3s and 6s here.) Many foods contain both fatty acids. To ensure you get your fill of -3, you'll need to be conscientious at the grocery store. Here are 11 ways to get more omega-3 and crowd out omega-6:
Salmon. This fatty fish is exploding with omega-3 and is relatively low in omega-6. It just may be the best omega-3 bang for your buck in the seafood aisle.
Bluefin tuna. This fatty fish is packed with omega-3s and low in omega-6. Not so keen on tuna? You've got choices: mackerel, herring, and rainbow trout.
Anchovies and sardines. Though not everyone's favorite, these slimy, oily options are other good omega-3 sources. They also tend to be high in sodium, though.
Crustaceans. Fish isn't the only kind of seafood that packs an omega-3 wallop. Shrimp, mollusks, and Alaskan king crab are also excellent sources that also won't load you up with omega-6.
Oils. Throw a dash of flaxseed oil onto salad and start cooking with canola oil for a nice hit of omega-3. By subbing out other vegetable oils (like soybean, corn, and cottonseed oils), you'll also lessen your omega-6 load.
Beans. Some legumes are better than others for tipping the omega balance your way. Kidney, pinto, and mungo beans will do you right. Chickpeas are less helpful.
Nuts and seeds. Add a nutty flavor to salad, yogurt, or morning mueslix with walnuts or flaxseed. A small handful of either will up your omega-3 intake.
Spinach. Popeye was on to something. Serve up this leafy green in a salad, or sauté it and add it to pasta.
Winter squash. Keep an eye out for this seasonal vegetable—it makes an interesting side dish that boosts your omega-3 intake.
Broccoli and cauliflower. These cruciferous veggies are on your side when it comes to omega-3s.
Papaya. A tropical delight, papaya may be the only fruit in your supermarket with more omega-3 than omega-6.
For more advice on balancing essential fatty acids in your diet, read "The Right Way to Get Your Omega-3s and -6s."

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Selenium, Vitamins E and C Won't Prevent Prostate Cancer

In findings that were released early because of the public health implications, the results of two large randomized, controlled clinical trials showed the supplements failed to provide a cancer-prevention benefit, despite past findings that seemed to indicate great promise -- particularly for selenium. Both studies were expected to be published in the Jan. 7 print issue of the Journal of the American Medical Association.
"Our results showed no evidence of benefit from selenium and vitamin E on prostate cancer and other cancers," said the lead author of one of the studies, Dr. Scott Lippman, a professor of medicine in the division of cancer medicine at M.D. Anderson Cancer Center, in Houston.

Lippman's study, known as the SELECT trial, included more than 35,000 men. Black men included in the study were all over 50, and men from other races were all over 55. (Blacks have a higher risk of developing prostate cancer than do men of other races, according to the American Cancer Society.)
The men were randomly assigned to one of four groups: selenium; vitamin E; selenium and vitamin E; or a placebo.
The average follow-up time was more than five years.
The researchers found no statistically significant difference between the groups, and the trial was ended early, because there was no convincing evidence of efficacy.
The second study, done by Harvard researchers, included almost 15,000 male physicians over 50 who were randomly assigned to receive vitamin E, vitamin C, or a placebo. The average follow-up time for this trial was eight years.
Again, no statistically significant benefits were found from either vitamin C or E when it came to preventing prostate and other cancers
These studies are just the latest in a long list of recent research that's been discounting the use of individual vitamins and supplements for chemoprevention. Other recent studies have suggested that vitamins, B, C, D, E, folic acid and calcium taken alone, or in various combinations, aren't effective for cancer prevention.
"Single-agent interventions, even in combinations, may be an ineffective approach to primary prevention in average-risk populations," wrote Dr. Peter Gann, the author of an accompanying editorial in the same issue of the journal.

Andrew Shao, vice president of scientific and regulatory affairs for the Center for Responsible Nutrition in Washington, D.C., said he thought researchers need to "redefine our expectations for nutrients.
They're not magic bullets, though they do have tangible effects."
Shao said studies that look at vitamins and cancer prevention tend to treat vitamins the same way they would a targeted pharmaceutical agent. But, he said, "the whole body is affected by nutrients, while pharmaceuticals are highly specialized and targeted to specific cells."
"It would be a mistake to look at one trial that answers a very specific question and say these nutrients don't work at all," said Shao.
Lippman, however, said he doesn't recommend the use of supplements for cancer prevention. "There's no evidence to support taking these," he said.

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2 Diabetes Drugs Double Fracture Risk in Women

WEDNESDAY, Dec. 10 (HealthDay News) -- Two widely prescribed diabetes drugs, Avandia and Actos, double the risk of fractures in women but not in men, a new British analysis finds. Avandia (rosiglitazone) and Actos (pioglitazone) are used to lower blood sugar in patients with type 2 diabetes.

Recent studies have suggested that the risk for heart failure, death and heart attack were increased with Avandia, touching off a controversy that resulted in new U.S. Food and Drug Administration-mandated label warnings about the drug."Women who are taking these drugs should reconsider the options," said lead researcher Dr. Yoon Loke, a clinical senior lecturer at the University of East Anglia in Norwich. "There are quite a lot of choices for women with type 2 diabetes. I am not sure that taking a drug that causes fractures is the best choice."There are about 4 million people in the United States who take these drugs, which are called thiazolidinediones, Loke noted.The report was published in the Dec. 10 online issue of the Canadian Medical Association Journal. For the meta-analysis, Loke's team evaluated 10 trials that included 13,715 diabetics taking Avandia, Actos, or neither drug. The studies found that these drugs reduced bone density in the spine and hips of women taking these medications. Loke's group estimated this loss of bone density would double the risk of fractures in women taking either drug.

For women already at risk for fractures, the researchers estimated one fracture would occur for every 21 women, and for those at low risk for fractures, one fracture would occur in 55 women taking these drugs.However, no effect on bone density among men was seen in any of the studies the researchers analyzed.Loke speculates that women are affected because of an interaction between the drugs and estrogen, which weakens bones in women.

The difference may also result from women having smaller, thinner bones to begin with, so that even a loss of a little bone mass can increase the risk of fractures, Loke added. Loke thinks that these drugs need stronger warnings about potential side effects. "The U.S. Food and Drug Administration needs to give a much stronger warning to women.

And the warning should be that really these drugs should be avoided if at all possible," he said. Dr. Lorraine Lipscombe, from the Institute for Clinical Evaluative Sciences and the University of Toronto in Canada and author of an accompanying journal editorial, thinks this study raises more concerns about the use of these drugs. "This evidence adds to the growing concern regarding these drugs, which have also been associated with a higher risk of heart failure, and possibly heart attacks," Lipscombe said. "Because diabetes drugs are typically approved based on their effects on sugar control rather than long-term outcomes, these adverse effects have only emerged after the drugs have been on the market.

"There is still not enough evidence as to the clinical benefit of these drugs -- aside from lowering blood sugar -- therefore the use of these drugs in diabetes treatment is unclear, Lipscombe said."Because clinical trials are designed to assess the expected effects of drugs, they often don't have enough power to detect unexpected or less common effects," Lipscombe said.

"Therefore, a more standardized post-marketing surveillance process is needed to ensure that potential adverse effects are recognized as early as possible."GlaxoSmithKline, the maker of Avandia, said this study rehashes something which is already known and reflected on its label. In addition, the company stands behinds the drug as "a safe and effective treatment for type 2 diabetes for the appropriate patient.""The association with thiazolidinediones on bone fracture has been previously reported," said GlaxoSmithKline spokesman Jeff McLaughlin.

"The labeling for rosiglitazone and pioglitazone notes the observation of an increased incidence of bone fractures in women taking the medication.

"The risk of fracture should be considered in the care of patients, McLaughlin said. "In addition, GlaxoSmithKline has previously communicated this information directly to physicians via a health-care provider letter," he noted.

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