Health Articles

Washington (CNN) -- An entire class of statin drugs will get new labels that alert the public to safety concerns, the Food and Drug Administration announced Tuesday.

Statins, which treat cholesterol, now will come with labels that include a warning that the drugs, taken by almost 32 million Americans, can cause memory loss and confusion. The FDA says reports in general have not been serious, and the symptoms subsided when patients stopped taking the medications.

The new labeling will also warn doctors and patients that statins can cause hyperglycemia, an increase in blood sugar levels and increase the risk of Type 2 diabetes.

The FDA will no longer recommend routine and periodic monitoring of liver enzymes of patients taking statins. Instead, it said liver enzyme tests should be performed before a patient starts taking statins, and then only when clinically indicated. That's because according to the FDA, serious injury to the liver is rare, and routine monitoring doesn't detect or prevent it. The new label will tell patients who experience fatigue, loss of appetite, dark urine, upper stomach pain or jaundice to notify their doctor immediately.

There also will be a label change specific to lovastatin (Mevacor). Certain medicines interact with this particular statin, increasing the risk of myopathy, or muscle damage. The agency says some drugs should never be taken with Mevacor including protease inhibitors, a class of HIV drugs and certain drugs used to treat bacterial and fungal infections.

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A new study suggests that the 6% to 10% of Americans who use prescription sleep medications such as zolpidem (Ambien), temazepam (Restoril), eszopiclone (Lunesta) and zaleplon (Sonata) are more likely to develop cancer, and far more likely to die prematurely, than those who take no sleep aids.

The increased rates kick in at really low levels too, the study says. For those prescribed as few as one to 18 sleeping pills in a year, deaths during the period of the new study were more than three and a half times greater than for those who got no such prescriptions, the study says. And for patients who took home the largest number of prescriptions for sleep aids--for more than 132 pills per year--the risk of death was five times greater than among those who appeared to take no sleep aids, according to the study.

Studies such as this one do not establish whether sleep drugs are a cause of the increased cancers and deaths or whether, perhaps, those who are at greater risk of dying or developing cancer are simply more likely to seek a prescription for sleep problems. To establish such cause-and-effect relationships, clinical trials, which would compare subjects taking sleep medications against those taking a sham drug, would be necessary, said study coauthor Dr. Daniel F. Kripke, a professor of psychiatry emeritus at UC San Diego now affiliated with the Scripps Clinic in La Jolla.

In addition, the "all-cause mortality" used in the study is a crude measure of a drug's risk, because the measure aggregates a wide range of seemingly unrelated health crises: automobile accidents, injuries, suicides, infectious diseases such as influenza, and chronic conditions, including asthma, diabetes and cancer.


The study, released this week by the British medical publication BMJ Open, found an increase in cancer incidence among those taking sleep medications that was modest but statistically significant. Compared with patients with no record of taking prescription sleeping pills, the study says, those who were the heaviest users of prescription sleep aids were 35% more likely to be diagnosed with cancer during the study period.

The use of sedative medications was a better predictor than a participant's current smoking habit of whether he or she would develop lymphoma or cancer of the lung, colon or prostate during the study period, according to the research.

Conducted by researchers from Scripps  and the Jackson Hole Center for Preventive Medicine in Jackson, Wy., the study tracked 10,531 patients given prescriptions for hypnotic sedatives for at least three months and for as long as four years. For comparison, researchers matched each patient prescribed with a sleep aid with at least two patients of similar age, gender and health status who had no record of having had sleep aids prescribed.

Zolpidem--sold as Ambien--was the most widely used prescription sleep medication used by study participants, followed by Restoril, the research says. But 4,117 of the participants got prescriptions for other sleep aids, including Lunesta, Sonata, benzodiazepines, barbituates and sedative antihistamines.

Given the millions of Americans for whom prescription sleep medication is a routine habit, the authors estimate that in 2010 alone, 320,000 to 507,000 deaths in the United States may have been associated with prescription sleep-aid use. Despite evidence that they may not add much to a night's sleep, Americans in 2010 filled some 66 million prescriptions for "hypnotics and sedatives," according to IMS Health, which tracks drug trends. That makes sleep aids the 20th most used class of prescription therapies.

Kripke  acknowledged he was "very shocked" by the higher cancer levels he found in this large population. "I suspect people who work for the manufacturers of these drugs might be shocked too."

Sanofi-Aventis, the maker of Ambien, said Tuesday in a statement that the BMJ Open study had limitations beyond those acknowledged by its authors. The company called the study's conclusions "highly questionable," and cited its average follow-up of 2.5 years as insufficient to detect whether cancers were new, and might be the result of sleep aids, or whether they had already taken hold at the time a patient got a prescription for sleep problems.

Kripke agreed that cause and effect had not been established but underscored that a litany of studies have stirred concern about the safety of sleep medications, including research that was submitted to the Food and Drug Administration when some of these drugs were approved.

Kripke said that beyond their common role in fatal medication overdoses, there's evidence that widely used sleep medications raise risks for many ills: "hangover" effects dull alertness and cognitive performance, which may lead to accidents and injuries; studies (including this one) have found that gastroesophageal regurgitation and peptic ulcers are more common among those taking sleep aids, which could drive up rates of infection and of cancer; other studies have linked sleep aids' use with  depression and sleep apnea, which in turn raise risks of suicide, diabetes and heart disease.

As for how sleep medicine could be linked to cancer, that is harder to discern. A 2008 study by Kripke on rodents found hypnotics to have a carcinogenic effect, and suggested they can cause chromosomal damage. But human studies have been more mixed.

For those who rely on prescription sleep drugs to get to sleep and stay asleep, Kripke, a specialist in sleep disorders and their treatment, said that changes in "sleep hygiene" can make a difference, as can cognitive-behavioral therapy. But he added that many--especially older patients-- who lean on sleep aids should know that they may function perfectly well with a little less sleep, and that medications do not add large chunks of sleep-time to a night's rest anyway.

The “epidemics” associated with life in America are most often the result of the western diet and lifestyle. One of the precursors to a host of other epidemic conditions is hypertension or high blood pressure. Hypertension, as high blood pressure is also known, affects 30% of the American population and is a preventable condition. 

The Western lifestyle—diet, low physical activity levels and stress—contributes to a wide variety of chronic diseases and conditions in Americans. These conditions collectively afflict 65% of the adult population in the U.S., while they are rare in cultures that have been isolated from exposure to a western lifestyle.

In fact, as traditional societies begin to adopt western foods and lifestyles, their incidences of chronic conditions such as cancer, diabetes, heart disease, hypertension, obesity and osteoporosis ^[1] rose dramatically.

An example of this is found in the Canadian Inuit of Nunavik, Quebec. In September of 2009, Dr. Marie-Ludivine Chateau-Degat told the Canadian Cardiovascular Congress that the recent reach of Western foods has severely impacted the health of the natives. The traditional Inuit diet had consisted of fish, seafood, caribou, wild fowl and other marine mammal meat before 1992. The consumption of such a diet included physical labor and activity, the pooling of communal resources, social activities centered around the collective good and social ties, and a diet rich in unprocessed foods, sea salt and other nutrients.

By 2004, store-bought foods had mostly replaced the native diet. 95% of the sodium the Intuits’ now ingest comes from processed foods in the form of highly processed, iodized salt. The majority of carbohydrates they ingest come in the form of sugary drinks. Intake of dietary fiber and essential vitamins and minerals has plummeted, while hypertension, diabetes, heart disease and obesity have soared in the population.

Blood pressure

Most Americans don’t even realize they have high blood pressure until serious problems arise.

Blood pressure is a combination of systolic and diastolic pressure. Systolic pressure represents blood force or pressure while the heart is beating and diastolic pressure stands for blood pressure when the heart is at rest.

Systolic pressure is always the first or top measurement in a blood pressure reading. In a reading of 140/90, 140 represents systolic pressure and 90 represents diastolic pressure. 

In prehypertension, systolic numbers range from 120-139 and diastolic numbers range from 80-89. 

Stage 1 hypertension numbers vary from 140-159 for systolic values and 90-99 in diastolic numbers. 

With Stage 2 hypertension, systolic readings are 160 or higher and diastolic readings measure 100 or higher. 

Although both numbers are significant, after about age 50, the systolic number is most important. Only 10% of high blood pressure cases are due to secondary or identifiable causes such as medications or conditions and diseases of other organs.

Avoid These Like the Plague

High fructose corn syrup ^[2]? If you eat any packaged foods or sodas, most likely you do, and you’re also more likely to develop hypertension (among other problems) because of it. Americans consume 30% more sugar than they did just 20 years ago and 4 times as much as they did 100 years ago, before the advent of highly processed foods. The obesity rates then were less than 5%, while today 64.5% of American adults are overweight and 30.5% are obese.

Researchers studied 4,528 adults that had no prior history of hypertension.  Those who ingested more than 74 grams of added sugar (about the amount in 2 ½ sugary drinks) daily, led to 28%, 36% and 87% increased risk in high blood pressure readings over time. The percentages correspond to blood pressure readings of 135/85, 140/90 and 160/100.

Another study has looked at American sodium intake. Highly refined salt exists in large amounts in processed foods. The study predicted that reducing sodium intake could eliminate 11 million cases of high blood pressure and save the U.S. $32 billion annually.

Research estimates that more than 77% of America’s sodium intake comes in the form of processed foods rather than salt added to foods while cooking or eating at home. Fast food, another fixture of the western lifestyle, is loaded with sodium. Replace all processed and refined salt with natural sea salt.

Helpful Foods

Potassium: is a compound that seems to protect people from the development of hypertension. Supplements of potassium don’t work well according to research, but foods that contain them do.

Spinach: Spinach is rich in magnesium and folate which can help prevent high blood pressure and cardiovascular disease.

Sunflower Seeds: Rich in potassium, magnesium and healthy plant fats, sunflower seeds can help reduce cholesterol levels, opening up blood vessels and promoting healthy blood pressure.

Bananas: Bananas contain loads of potassium and fiber ^[3].

Healthy Fats: Oily, cold-water fish provides  omega-3 fatty acids, a healthy balancing technique to the overload of omega-6 and omega-9 fatty acids that are overly prevalent in processed foods, fast and convenient foods and much of the western diet.

Garlic: Research on the health benefits of garlic is finding more and more miraculous effects. Among them, garlic seems to help thin the blood, prevent the blockage in blood vessels, and so lower blood pressure.

Tomatoes: Tomatoes are loaded with calcium, potassium, vitamins A, C and E and lycopene. Compounds in tomatoes can lower cholesterol buildup in blood vessels and combat the development of hypertension in a variety of ways. Lycopene, one of the tomato’s most useful compounds, is activated by heat, so add tomatoes to your next chili or stew.

Broccoli: Broccoli has been found to have a whole host of beneficial health effects including high amounts of potassium and chromium that help regulate blood sugar levels and weight, both related to high blood pressure.

Melon: Melon is rich in potassium. Cantaloupe and watermelon are especially rich sources.

Lifestyle Aids

Regular exercise ^[4] and diet ^[5] play a large role in the development (or not) of hypertension. One of the most detrimental components of the western lifestyle is stress.Managing stress ^[6] includes relaxation techniques such as deep breathing, yoga, journaling or art therapy.

You can raise your blood pressure to alarming levels just by thinking or stressing about events. Imagined events have as much physiological effect as real ones. This is the basis of Post Traumatic Stress Disorder and the improvement of performance in businessmen and Olympic athletic gains with visualization.

The western lifestyle might include career and lifestyle choices that incite chronic disease but that doesn’t mean that you have to proscribe to them. Going against a cultural current takes strength, but the failure of our cultural norm has contributed to the splintering of its route and the availability of alternate paths.

The fight for a culture’s health depends less on science that focuses on finding magical cures in drugs, and more on making fundamental shifts in food production, availability, our connections to food, our work life and stress factors, and re-prioritizing values. The best preventative measure? A healthy lifestyle. It’s common sense, really. With this article and the others on this site, you are now equipped to truly maximize your health.

Dr. Axe's Action Steps

1. Stop the trips to the fast food drive-thru! Eliminate processed foods and sodas that are laden with sugar, high fructose corn syrup, refined salt and unhealthy fats.
2. Eat a wide variety of foods, focusing especially on adding more vegetables to your diet.
3. Supplement with 1 Tbsp. of cod liver oil or 1 salmon oil capsule daily and I-2 cloves of garlic daily.
4. Learn how to recognize and manage stress in your life. Consider making a vision board with your goals. Include pictures and strategies for achieving them.