FDA Warns of Two Supplements Containing Pharmaceutical-like Compounds
The following article was published by Consumer Labs.
On May 10, 2007, the FDA advised consumers not to purchase or use “True Man” or “Energy Max” products promoted and sold as dietary supplements throughout the United States. Both products — touted as sexual enhancement products and as treatments for erectile dysfunction (ED) — are illegal drug products that contain potentially harmful, undeclared ingredients.The products contain substances called analogs that have similar structures to active ingredients in approved prescription drugs.
Consumers should discontinue use of True Man and Energy Max and consult their health care professional about approved treatments for ED.FDA encourages men who experience ED to seek guidance from a health care professional.
FDA has not approved True Man and Energy Max; therefore the safety and effectiveness of these products are unknown. Both products are often advertised as “all natural” alternatives to approved ED drugs in advertisements appearing in newspapers, retail stores, and on the Internet.
“These products threaten the health of the people using them because they contain undeclared chemicals that are similar to the active ingredients used in FDA-approved prescription drug products,” said Steven Galson, M.D., MPH, director of the FDA’s Center for Drug Evaluation and Research.”The risk is even more serious because consumers may not know that these ingredients can interact with medications and dangerously lower their blood pressure.”
The undeclared analog ingredients in True Man and Energy Max may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.
FDA chemical analysis revealed that Energy Max contains thione analog of sildenafil, a substance with a structure similar to sildenafil, the active ingredient in Viagra, an FDA-approved drug for ED. Substances like this are called analogs because they have a structure similar to another drug and may cause similar side effects and drug interactions.
True Man contains a thione analog of sildenafil or piperadino vardenafil, an analog of vardenafil, the active ingredient in Levitra, another FDA-approved prescription drug for ED. Neither the thione analog of sildenafil nor piperadino vardenafil are components of approved drug products.
True Man is sold in boxes containing a 10-capsule blister pack. Energy Max is sold in boxes containing two 10-capsule blister packs. Both products are distributed and packed by America True Man Health, Inc., West Covina, Calif. A review of the ingredient statements for both products revealed that neither piperadino vardenafil nor thione analog of sildenafil are listed as an ingredient, even though one or more of those ingredients is present in the products.
Consumers should report adverse events related to these products to MedWatch, the FDA’s voluntary reporting program: www.fda.gov/medwatch/report.htm, (800) 332-1080, Fax: (800) 332-0178, Mail: MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20857-9787.
Asprin Risks Compare to Driving a Car
Taking an aspirin every day may help prevent heart disease and stroke but, for a middle-aged man, it is nearly as risky as driving a car or working as a firefighter, researchers said Tuesday.While people are poor at assessing true risks, they are often willing to take on those risks in exchange for the benefits — which can include simply having fun, said Joshua Cohen and Peter Neumann of Tufts-New England Medical Center.
Writing in the journal Health Affairs, they said federal regulators must take the true risks into account, and balance them against the benefits, when deciding whether to approve or withdraw drugs.
People are bad at estimating risk, the researchers said.
“In general, they tend to overestimate the probability of small and especially dreaded risks while underestimating the probability of large risks,” Cohen and Neumann wrote.
They calculated the risks of various voluntary actions, starting with deaths associated with taking drugs.
“We included selected drugs for which we could develop a reasonable annual mortality risk estimate,” they wrote.
For 50-year-old men, taking a full-sized, 325 mg aspirin every day to prevent heart disease and stroke carries a risk of 10.4 deaths per 100,000 men per year over and above their overall death risk.
Using Vioxx for arthritis pain carried a risk of 76 deaths per 100,000 people per year. Merck and Co withdrew Vioxx in September 2004 after it was shown to double the risk of heart attack and stroke.
“The finding that taking Vioxx for a year is much more risky than a year of car travel, swimming or being a firefighter suggests that greater scrutiny of drug risks may be warranted,” the researchers wrote.
Using Tysabri, known generically as natalizumab, to treat multiple sclerosis raises the death rate by 65 per 100,000 people a year.
Biogen Idec’s and Elan Corp’s Tysabri was withdrawn from the U.S. market in 2005 after three patients contracted a rare brain disease, but the Food and Drug Administration re-approved it after many patients said they would use it despite the risks.
Cutting trees risky
As for job-related deaths, the riskiest profession was being a tree-feller, with 55 deaths per year or a risk of 357 deaths per 100,000 people a year.
Firefighters have a risk of 10.6 deaths per 100,000 people per year, compared with 3.9 for all occupations and 0.4 for office workers.
Being a truck driver is risker than being a firefighter, with 44.8 deaths per 100,000 people per year.
Bicycling is more dangerous than skiing, the researchers found — bicyclists face a death rate of 2.1 per 100,000 people a year, compared with 0.49 for skiers.
Swimming has a death risk of 0.88 per 100,000 people a year but climbing mountains in the Himalayas carries a 13,000 per 100,000 climbers per year risk.
For transport, the researchers estimated risks both in terms of 100,000 people per year and per 100 million miles traveled.
Traveling by commercial airliner carries a risk of 0.03 deaths per 100 million miles or 0.15 deaths per 100,000 people a year.
Car and light truck travel has a 0.7 fatality risk per 100 million miles or 11 per 100,000 people per year, compared to 450 for motorcycle travel and 1.3 for using a cell phone while driving.
Cinnamon Balances Blood Sugar
Just half a teaspoon of cinnamon a day significantly reduces blood sugar levels in diabetics, a new study has found. The effect, which can be produced even by soaking a cinnamon stick your tea, could also benefit millions of non-diabetics who have blood sugar problem but are unaware of it.The discovery was initially made by accident, by Richard Anderson at the US Department of Agriculture’s Human Nutrition Research Center in Beltsville, Maryland.
“We were looking at the effects of common foods on blood sugar,” he told New Scientist. One was the American favourite, apple pie, which is usually spiced with cinnamon. “We expected it to be bad. But it helped,” he says.
Sugars and starches in food are broken down into glucose, which then circulates in the blood. The hormone insulin makes cells take in the glucose, to be used for energy or made into fat.
But people with Type 1 diabetes do not produce enough insulin. Those with Type 2 diabetes produce it, but have lost sensitivity to it. Even apparently healthy people, especially if they are overweight, sedentary or over 25, lose sensitivity to insulin. Having too much glucose in the blood can cause serious long-term damage to eyes, kidneys, nerves and other organs.
Molecular mimic
The active ingredient in cinnamon turned out to be a water-soluble polyphenol compound called MHCP. In test tube experiments, MHCP mimics insulin, activates its receptor, and works synergistically with insulin in cells.
To see if it would work in people, Alam Khan, who was a postdoctoral fellow in Anderson’s lab, organised a study in Pakistan. Volunteers with Type 2 diabetes were given one, three or six grams of cinnamon powder a day, in capsules after meals.
All responded within weeks, with blood sugar levels that were on average 20 per cent lower than a control group. Some even achieved normal blood sugar levels. Tellingly, blood sugar started creeping up again after the diabetics stopped taking cinnamon.
The cinnamon has additional benefits. In the volunteers, it lowered blood levels of fats and “bad” cholesterol, which are also partly controlled by insulin. And in test tube experiments it neutralised free radicals, damaging chemicals which are elevated in diabetics.
Buns and pies
“I don’t recommend eating more cinnamon buns, or even more apple pie - there’s too much fat and sugar,” says Anderson. “The key is to add cinnamon to what you would eat normally.”
The active ingredient is not in cinnamon oils. But powdered spice can be added to toast, cereal, juice or coffee.
Anderson’s team were awarded patents related to MHCP in 2002. But the chemical is easily obtained. He notes that one of his colleagues tried soaking a cinnamon stick in tea. “He isn’t diabetic - but it lowered his blood sugar,” Anderson says.
The group now plans to test even lower doses of cinnamon in the US, and also look at long-term blood sugar management with the spice.
Journal reference: Diabetes Care (vol 26, p 3125)
Chiropractic Treatment of Headaches
Headaches can range from annoying to debilitating and their cause can be benign or life threatening. The majority of headaches are benign and are caused by dehydration, muscle spasms, stress or veterbral misalignments.
It is important to know what type of headache you are suffering from prior to prescribing a type of treatment. If you are suffering from a dehydration headache, all the aspirin in the world won’t decrease your pain. Headaches can also be caused by serious conditions such as tumors, therefore you need to speak with a healthcare practitioner if your headaches last longer than a week.
The following is a brief description of the most common types of headache classifications.
1. Tension Headaches:
Description: Tension type headaches are the most common, affecting upwards of 75% of all headache sufferers. As many as 90% of adults have had tension–type headaches.
Tension–type headaches usually involve a steady ache, rather than a throbbing one, are described as a feeling of pressure or tightening, may last minutes to days, affect both sides of the head, and do not worsen with routine physical activity. It may also be accompanied by photophobia or phonophobia (hypersensitivity to light and noise, respectively.). Nausea is usually absent. Some people get tension–type (and migraine) headaches in response to stressful events. Tension–type headaches may also be chronic, occurring frequently or daily. Psychologic factors have been overemphasized as causes of headaches.
Rebound Headache: Rebound headache may occur among people with tension–type headaches, as well as in those with migraines. It appears to be the result of taking prescription or nonprescription pain relievers daily or almost every day, contrary to directions on the package label. If prescription or nonprescription pain relievers are overused, headache may “rebound” as the last dose wears off, leading one to take more and more pills.
Treatment: Chiropractic treatment has been shown to provide relief to patients who suffer from tension and rebound headaches. A randomized controlled trial compared six weeks of spinal manipulative treatment of tension-type headache by chiropractors to six weeks of medical treatment with amitriptyline, a medication often prescribed for the treatment of severe tension headache pain. Researchers found that chiropractic patients experienced fewer side effects (82.1%) and while both were effective during the treatment phase of the study, only the chiropractic patients continued to report fewer headaches when treatment ended.
Stress relief is an important component in the treatment of tension headaches. Simple meditation techniques have been shown to decrease stress can help to prevent tension headaches. You can find out more about how to use meditation to decrease stress at www.highlandpdx.com, click Dr. Bingham’s blog and type in meditation in the search window.
2. Cervicogenic Headaches:
Description: Cervicogenic headache originates from disorders of the neck and is recognized as a referred pain in the head. Primary sensory afferents from the cervical nerve roots C1–C3 converge with afferents from the occiput and trigeminal afferents on the same second order neuron in the upper cervical spine. Consequently, the anatomical structures innervated by the cervical roots C1–C3 are potential sources of cervicogenic headache.
Cervical headache is often precipitated by neck movement and/or sustained awkward head positioning (such as painting the ceiling, or washing the floor) and can reproduced with pressure over the upper cervical or occipital region on the symptomatic side. It is often accompained by decreased range of motion in the neck, neck, shoulder, or arm pain of a rather vague nature or, occasionally, arm pain of a shooting nature.
Treatment: Because these types of headaches are precipitated by problems in the joints of the neck it is important to see a chiropractor for treatment of the headaches. These headaches are common following an injury like motor vehicle accident or a blow to the head but can also be caused by poor posture and repetitive stress. Chiropractors specialize in the diagnosis and treatment of joint problems of the spine. The chiropractor will also give you exercises and stretches to help prevent this condition from returning.
3. Migraine Headaches
Description: Migraine headaches are less common in tension–type headaches. Nevertheless, migraines afflict 25 to 30 million people in the United States. As many as 6% of all men, and up to 18% of all women experience a migraine headache at some time.
Among the most distinguishing features is the potential disability accompanying the headache pain of a migraine: migraines may last 4-72 hours, are typically unilateral (60% of reported cases), throbbing, of moderate to severe intensity, and are aggravated by routine physical activity.
Nausea, with or without vomiting, and/or sensitivity to light and sound often accompany migraines. An “aura” may occur before head pain begins–– involving a disturbance in vision, and/or an experience of brightly colored or blinking lights in a pattern that moves across the field of vision. About one in five migraine sufferers experiences an aura.
Usually, migraine attacks are occasional, or sometimes as often as once or twice a week, but rarely occur daily.
Treatment: In the treatment of migraine headaches is important to determine the triggers that cause these headaches.
For some people food is a trigger. The most common known food triggers are the four C’s; cheese, chocolate, caffeine and citric acid. Citric acid is a preservative that is found in a number of different foods and has been shown to be a trigger for migraine headaches. It is important to remember that everyone’s triggers may differ and it is important to determine what your own individual triggers. Using a food journal can be an effective way of tracking headache symptoms and relating them to food triggers.
Stress has also been shown to be a trigger for these headaches. Meditation has been shown to be beneficial in decreasing the stress that can trigger these headaches. For more information on meditation see the treatment section under tension headaches.
4. Food Allergy Headaches:
Description: Food Allergy headaches are being diagnosed at an increasing rate. There are two reason why we have seen this increase in diagnosis. First there is a better understanding of how foods affect our bodies. For years we have know that the body can react unfavorably to foods such as peanuts and shellfish. Often these reactions can be harmful if not fatal. Due to the severe nature of these allergies, they have been studied extensively. Food allergy headaches have not been studied as thoroughly but recent research is showing a connection between food allergies and headaches.
Food allergens (the food fragments responsible for an allergic reaction) are proteins within the food that usually are not broken down by the heat of cooking or by stomach acids or enzymes that digest food. As a result, they survive to cross the gastrointestinal lining, enter the bloodstream, and go to target organs, causing allergic reactions throughout the body.
Treatment: The treatment of a food allergy headache involves removing the particular offending food. This can be very difficult in a society where we tend to eat meals that contain many different kinds and types of food. The gold standard for treatment of food allergies is the food elimination diet. This diet involves removing all foods from your diet except for a small number of foods that have been shown to be hypoallergenic. Once your body has eliminated the allergens which typically takes two-weeks, certain individual foods are reintroduced and symptoms are noted. Food allergies can also be tracked using a food diary. Unfortunately some foods may cause an immediate reaction while others may take hours or days to produce a reaction. This complicates the tracking of symptoms associated with different foods. There are also different blood tests available that measure how your body reacts certain foods. These test are provided by naturopaths and some chiropractors.
5. Cluster Headaches:
Descrition: Cluster headaches are relatively rare, affecting about 1% of the population. They are distinct from migraine and tension–type headaches. Most cluster headache sufferers are male –– about 85%.
Cluster headaches come in groups or clusters lasting weeks or month. The pain is extremely severe but the attack is brief, lasting no more than a hour or two. The pain centers around one eye, and this eye may be inflamed and watery. There may also be nasal congestion on the affected side of the face.
These “alarm clock” headaches may strike in the middle of the night, and often occur at about the same time each day during the course of a cluster. A history of heavy smoking and drinking is common, and alcohol often triggers attacks.
Chiropractic headache research.
There has been numerous studies done on the treatment of headaches with chiropractic. The following two studies are the most widely referenced and well respected. For more information visit Dr. Bingham’s blog.
Duke Study
A literature review performed by researchers at Duke University looked at a number of studies that looked at chiropractic treatment for headaches. Researchers concluded the following: “Manipulation appeared to result in immediate improvement in headache severity when used to treat episodes of cervicogenic control. Furthermore, when compared to soft-tissue therapies (massage), a course of manipulation treatments resulted in sustained improvement in headache frequency and severity.”
Migraine Study
This study compared chiropractic spinal manipulation to amitriptyline which is a medication often prescribed for the treatment of headache. The researchers found that “spinal manipulation seemed to be as effective as a well-established and efficacious treatment (amitriptyline), and on the basis of a benign side effects profile, it should be considered a treatment option for patients with frequent migraine headaches.”
In other words, the safety and effectiveness of chiropractic treatment or spinal manipulation in the treatment of headache should be considered by patients suffering these symptoms.
The researchers also found that in the weeks immediately following treatment, patients who had recieved spinal manipulation had a 42% reduction in headache frequency, compared to only 24% of those who took amtriptyline. The chiropractic group had fewer headaches even after treatment had ceased.
Peppermint Oil for Stomach Aches and Headaches
“The medicinal use of peppermint and other mint plants probably dates back to the herbal pharmacopoeia of ancient Greece, where peppermint leaf traditionally was used internally as a digestive aid and for management of gallbladder disease; it also was used in inhaled form for upper respiratory symptoms and cough,” write Benjamin Kligler, MD, MPH, from the Albert Einstein College of Medicine of Yeshiva University in New York, and Sapna Chaudhary, DO, from the Beth Israel Continuum Center for Health and Healing in New York. “Peppermint oil, which is extracted from the stem, leaves, and flowers of the plant, has become popular as a treatment for a variety of conditions, including irritable bowel syndrome (IBS), headache, and non-ulcer dyspepsia.”
- Peppermint oil appears to be mildly effective in reducing symptoms of IBS, particularly flatulence, abdominal pain, and distension, in adults. However, there has been significant heterogeneity among research into this subject.
- A study of children between the ages of 8 and 17 years who had IBS found that peppermint oil was more effective than placebo in reducing the severity of abdominal pain.
- 2 trials have demonstrated that treatment with peppermint oil reduced the risk for gastrointestinal spasm during barium enema, with peppermint associated with up to a 3-fold increase vs placebo in the rate of having a procedure free of spasm.
- The combination of 90 mg of peppermint oil plus 50 mg of caraway oil has been demonstrated to reduce symptoms of nonulcer dyspepsia, including fullness, bloating, and spasm. This combination should be used cautiously for patients with dyspepsia, as peppermint oil may promote gastroesophageal reflux.
- 2 studies have delineated the efficacy of topical peppermint oil in tension headache. In 1 study, a combination of peppermint and ethanol was superior to placebo in terms of analgesia. Another trial demonstrated that topical peppermint oil was similar to acetaminophen in terms of treatment efficacy.
- The therapeutic dosage in most trials of peppermint oil and IBS was 0.2 to 0.4 mL taken 3 times daily in enteric-coated capsules. The 1 trial examining its use for childhood IBS used a dosage of 0.1 mL of peppermint oil 3 times daily for children weighing less than 45 kg.
- Peppermint oil can be toxic in overdose, leading to interstitial nephritis and acute renal failure. Because it may promote gallstone formation, it should not be used in patients with cholelithiasis or cholecystitis. Peppermint oil also may trigger menstruation and should not be used during pregnancy.
- The most common adverse events associated with peppermint oil include allergic reactions, heartburn, perianal burning, blurred vision, nausea, and vomiting. Peppermint oil may inhibit the cytochrome P450 1A2 system.
Because peppermint oil may inhibit the cytochrome P450 1A2 system, it may interact with drugs metabolized via this system.
Peppermint oil is contraindicated in patients with hiatal hernia, severe gastroesophageal reflux, and gallbladder disorders and should be used with caution in pregnant and lactating women.
Mental Stimulation Brings Back Memories for Alzheimer’s Suffers.
Research has shown us that mental stimulation can prevent disorders such at dementia and Alzheimer’s, but new research shows us how living in a stimulating environment can bring back thoughts that were lost.
“We show, I believe, the first evidence that even if the brain suffered some very severe neurodegeneration and the individual exhibits very severe learning impairment and memory loss, there is still the possibility to improve learning ability and recover to a certain extent lost long-term memories,” according to Neuroscientist Li-Huei Tsai of the Howard Hughes Medical Institute and the Massachusetts Institute of Technology.
Tsai said if apparently lost long-term memories could be retrieved, this suggested the memories had not been actually erased from the brain.
The researchers used genetically engineered elderly mice in which they were able to activate a protein that triggered brain pathology very much like that of people with Alzheimer’s, with atrophy and loss of nerve cells.
Mice with Alzheimer’s-like brain damage put in the stimulating environment could remember that shock test far better than similar animals kept in standard cages. The playground mice also were better at learning new things than those kept in standard cages.
So, if you are feeling like your memory is slipping, it is time to break out the crossword puzzles and the trivial pursuit. Yet another example of “use it or lose it.”