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.
Tamiflu - FDA Warns against side effects
FDA released a warning regarding the use of Tamiflu, they warn of the potential risk for neuropsychiatric events associated with its use. These behaviors have been seen primarily in Japan with over 100 cases that have been reported. Effects of the medication include panic attacks, suicide attempts, hallucinations and delirium.
For many years Japan has closely followed and documented the effects of flu on their citizens. This explains why these cases have been noticed in Japan first, along with the higher use of the drug amongst the Japanese. Each year an estimated two million Americans take Tamiflu which has been shown to decrease the duration of the flu by a day or two. The flu season has not yet started in the US, so these cases have not been seen.
For more information:
NPR - Includes Audio
Asthma Drugs Increase Death Risks
Popular and long-acting asthma medicines such as Advair and Serevent pose a substantially increased risk of hospitalization and death to users compared with placebos, according to a new analysis of 19 studies on the subject.
“The use of long-acting [bronchodilators] could be associated with a clinically significant number of unnecessary hospitalizations, intensive care unit admissions and deaths each year,” according to Stanford researchers.
The Food and Drug Administration has voiced concerns about the widely used medicines, and last fall it required drug makers to prepare stiff new warnings to the package label. But the new analysis, published in the journal Annals of Internal Medicine, raises the possibility that the drug should be taken off the market if it continues to be so widely used.
Each day we learn of the harmful and potentially fatal side effects associated with many of the medications that are being consumed each day. Complimentary and alternative medicine techniques have been shown to treat conditions such as asthma with little or no side effects. Often asthma is triggered by a long acting food allergy or pressure on a never that controls the lungs.
Alternative medicine is not the answer in every case, but you owe it to yourself and your children to try a gentler healing method before resulting to medication.
Full Article: www.Washingtonpost.com
The First One is Free…The Next One Will Cost You!
There are few companies that spend the amount of money on marketing that pharmaceutical companies do. This should come as no surprise if you have turned on a t.v. or opened a magazine in the last 5 years. In her new book, The Truth About Drug Companies: How They Deceive Us and What to Do About It, Marcia Angell writes that big pharma spend 2.5 the amount of money on marketing that it does on research and development.
A new type of marketing has consumer groups concerned, free drugs! Companies making the offers include Pfizer, which offers a free prescription of the impotence drug Viagra for every six filled, and Sanofi-Aventis, which allows patients to try seven days of the sleeping pill Ambien at no cost. These offers are not tracked by doctors or pharmacists, unlike some free trial vouchers.
Providing a drug at a discount or for free might persuade them to insist on a drug that is not right for them and might be more costly in the future. Currently 23 groups have submitted complaints to the FDA regarding this new form of drug promotion.
It is true that the cost of drugs have become increasingly more expensive, but their are more effect ways to lower the cost of drug other than “free” samples. If spent less money on marketing drugs, those savings could be passed along to the consumer.
Skin infection “super-bacteria” on the rise
Examples of antibiotic-resistant bacteria are becoming more prevalent as science struggles to keep pace with the genetic modifications demonstrated by certain “super bacteria.” These bacteria, through modification, have been able to make themselves immune to some if not all types of antibiotics.
Methicillin-resistant Staphylococcus aureus, or MRSA, was once very rare and hardly seen in doctor’s offices. A recent study revealed that this once rare strain has been become increasingly more common and accounts for more than half of the skin infections treated in U.S. emergency rooms.
A common presentation is what looks like a spider bite or pimple that is not getting better. Patients rarely understand the gravity of situation prior to visiting their doctor.
Dr. Rachel Gorwitz of the U.S. Centers for Disease Control and Prevention, said: “I think no one was aware of the extent of the problem.”
Skin infections can be life-threatening if bacteria get into the bloodstream. Drug-resistant strains can also cause a vicious type of pneumonia and even “flesh-eating” wounds.
If you or your child is experiencing a skin irritation that looks like a spider bite or a pimple that is not getting better, visit your primary care physician. If he or she recommends antibiotic medications, question your physician about possibility of antibiotic-resistant bacteria.
Contamination prevention tips:
Wash hands thoroughly and often with soap and water.
Keep cuts and scrapes clean and covered with a bandage until healed.
Avoid contact with other people’s wounds or bandages.
Don’t share towels, wash cloths, razors, soap, ointments or other personal items.
Wipe down athletic gear like mats, head protectors and gym equipment with alcohol or antiseptic solution after each person uses it.
Full story: CNN.com
Name this Drug by Its Side Effects
- difficulty breathing
- closing of the throat
- swelling of the throat or face
- hives
- muscle cramp
- numbness and tingling
- ulcers
- rapid weight gain
- seizures
- black, bloody or tarry stools
- blood in urine or vomit
- decreased hearing or ringing in the ears
- jaundice
- abdominal pain, cramping
- indigestion
- heartburn
- dizziness
- headache
- nausea
- gaseousness
- diarrhea
- constipation
- depression
- fatigue
- weakness
- dry mouth
- irregular menstrual periods
Don’t forget - “side effects that are not list may also occur”
Sounds pretty bad huh? You might expect these side effects to belong to a harsh drug such as chemotherapy, but unfortunately these side effects belong to a much more common drug, ibuprofen (ie. Advil).
For more information: ibuprofen at Drugs.com
Dr. Bryan Bingham
Highland Chiropractic
MDs and Pharmacists Take a Stand Against NSAIDs
NSAIDs are pain relievers that reduce pain and swelling at the site of injury. About twenty NSAIDs are available with a doctor’s prescription. Three of these, ibuprofen, naproxen, and ketoprofen, also are available over-the-counter. The over-the-counter versions of some of these drugs are better known by names like Advil®, Motrin®, Aleve®and Orudis®. The only difference is that prescription versions are a higher strength than those purchased over-the-counter. Other examples of NSAIDs include products with aspirin that are available over-the-counter, like Bayer®and Excedrin®. NSAIDs also can be found in common cold and flu medications such as Advil Cold and Sinus®, Dimetapp Sinus®, Motrin IB Sinus® and Aleve Cold and Sinus®. (Look for aspirin, naproxen or ibuprofen on the box or bottle to find out if your medicine contains an NSAID.)
Newer NSAIDs include meloxicam (Mobic®) and a class of drugs known as COX-2 specific inhibitors. Examples of these drugs include celecoxib (Celebrex®), valdecoxib (Bextra®) and rofecoxib (Vioxx®). These newer NSAIDs are available only through a doctor’s prescription and may be safer for the stomach.
Why are NSAIDs harmful?
NSAIDs are intended for pain relief in most cases for no longer than 10 days. Unfortunately many people use NSAIDs to treat chronic conditions and continue to take them much longer than the recommended time period.
The extended use of NSAIDs leads to stomach problems ranging from mild stomach upset to stomach bleeding and ulcers. These problems occur because NSAIDs stop a substance in the body that protects the lining of your stomach from damage. At the same time, NSAIDs prevent the body’s normal ability to stop bleeding.
What is the REDUCE campaign?
The REDUCE campaign was created by American Gasteroenterological Association and the American Pharmacists Association to educate patients on the risks of NSAIDs.
To find out more about the REDUCE campaign visit their website at www.2reduce.org
Dr. Bryan Bingham
Highland Chiropractic
Get Rid Of Your Sleeping Pills…Now!
A study published in the Journal of the American Medical Association found cognitive behavioral therapy to be superior to sleeping pills.
For six weeks subjects either participated in 50-minute weekly counseling sessions, took a drug called xopiclone, or took a placebo.
Those who received therapy increased the time they spent in bed actually sleeping from 81.4 percent to 90.1 percent.
Those who received zopiclone had a decrease in sleep efficiency, from 82.3 percent to 81.9 percent.
Therapy participants spent more time in the deepest stages of sleep and less time awake at night than those who received zopiclone or placebo.
Full Article : Forbes
Teenagers getting high on what?
The 18-year-old French woman was hospitalized with scaly skin on her legs and hands, appearing unsteady and mentally sluggish, doctors said.
They found the condition puzzling, especially since the woman’s twin sister displayed similar, but less severe, symptoms and there was no family history of the problem, the doctors reported in this week’s New England Journal of Medicine that
Several days later, doctors discovered the cause: a bag of mothballs stashed in her hospital room.
The teenagers had been using the mothballs to get high, inhaling air from the bag for about 10 minutes a day because classmates had recommended it. The sicker of the young women also had been chewing half a mothball a day for two months.
The doctors described the high as “dangerous” and most likely under-reported in medical literature.
The teenager told the doctors that she continued to use the mothballs during her hospitalization “because she thought her symptoms were not related to her habit,” said Lionel Feuillet at the Hospital of Timone in Marseille, France.
Mothballs, used to prevent moth larva from getting into clothing, contain paradichlorobenzene, a substance also found in air fresheners and insect repellents that can cause liver and kidney failure, and severe anemia.
Full article: Yahoo Health
Dr. Bryan Bingham
Highland Chiropractic