The FDA received nearly 21,000 reports of serious drug reactions, including over 4,800 deaths, over that period. Two drugs accounted for a disproportionately large share of the problems -- heparin, a tainted blood thinner from China that caused an international safety scandal, and Chantix, a new anti-smoking drug from Pfizer.
Chantix had the most reports of any medication.
Earlier this year, the FDA warned that Chantix may be linked to psychiatric problems, including suicidal behavior.
Serious drug reactions are ones that cause hospitalization, require medical intervention, or place a life in jeopardy. The total of 20,745 cases reported from January to March was 38 percent higher than the average for the previous four calendar quarters, and the highest for any quarter.
Fatalities accounted for 23 percent of the cases.
As has been repeatedly demonstrated, and as this latest report so clearly illustrates, prescription drugs can, and frequently do, pose SERIOUS risks to your health.
More than 700,000 people visit U.S. emergency rooms each year as a result of adverse drug reactions. And, according to the U.S. Food and Drug Administration (FDA), adverse drug reactions from drugs that are properly prescribed and properly administered cause about 106,000 deaths per year, making prescription drugs the fourth-leading cause of death in the U.S.
Compare this to the death toll from illegal drugs -- which is about 10,000 per year -- and you begin to see the magnitude of the problem that the pharmaceutical industry is propagating.
The problem has reached such proportions that you now see public service announcements warning you about the dangers of pharmaceutical drug use and addiction, just like the ones you used to see against street drugs.
And when you consider the fact that the average American, aged 19 to 64, is now on close to 11 prescription drugs, it’s not difficult to see how serious health problems from side effects and misuse might ensue.
Reported Side Effects of Pharmaceutical Drugs Now Include a 1 in 4 Shot at Premature Death
This latest analysis of federal data by the nonprofit Institute for Safe Medication Practices (ISMP) offers up some truly shocking information.
Fatalities from adverse drug reactions – more than 4,800 of them -- accounted for 23 percent of all adverse reaction reports in the first quarter of 2008! (This is a 3 percent increase in prescription drug deaths from the last calendar quarter of 2007.)
Folks, if that’s not a wakeup call, I don’t know what is.
Two drugs accounted for a disproportionately large share of the problems.
Heparin, which was found to be the second most dangerous drug on the market, was also listed on the FDA’s latest list of 20 potentially dangerous drugs. I recently met Bill Faloon, the head of the Life Extension Foundation, and he told me his research suggested that anyone taking heparin would benefit from taking 45 mg of vitamin K2, which would not only stabilize the heparin dose, but prevent many of the devastating side effects.
The popular anti-smoking drug Chantix, on the other hand, was not on the FDA list. This is astounding considering the findings in this ISMP report.
Of the nearly 21,000 reports of serious drug reactions received by the FDA between January and March, 1,001 of them were linked to Chantix -- more than for the ten best-selling brand name drugs combined!
Chantix even out-harms the addictive troublemaker oxycodone, a potent pain medication.
While an estimated 3.5 million Chantix prescriptions have been written since its FDA approval in May 2006, government estimates place oxycodone prescriptions written at more than 7 million per year. Yet despite having about half the prescription rate, Chantix has received more than two-and-a-half times more adverse reaction reports than oxycodone.
And when you consider the fact that these numbers are based on a monitoring system that relies on voluntary reports from doctors only, the reality of this problem becomes truly staggering.
Several studies have already shown that as little as 1 to 4 percent of all adverse drug reactions are ever reported.
Paying to Use the MOST Dangerous Option Available
Currently, the warnings for Chantix say that you may be too impaired to drive or operate heavy machinery – a standard warning found on many medications – but offers no clues that patients taking Chantix may suffer blackouts and other problems that can lead to serious bodily harm.
Of the adverse reactions reported, 15 cases involved Chantix users involved in traffic accidents, and an additional 52 cases involving blackouts or loss of consciousness.
And while the FDA has issued warnings regarding Chantix's link to suicidal acts, thoughts or behaviors, psychosis, hostility and aggression, it has ignored other kinds of deadly harm for which no warnings currently exist.
In fact, of the 78 deaths reported from Chantix, only 28 resulted from suicide. According to the report there were numerous deaths from cardiac causes, both thromboembolic and arrhythmic.
In the fourth quarter of 2007, the other highest ranked drugs are all “black box warning” type of drugs; drugs that are intended for serious illness. In comparison, Chantix is intended for use in healthy people to help them quit smoking.
Never in the history of smoking cessation has any quitting product or technique harmed so many.
What Makes Chantix So Dangerous?
Chantix, which had the most adverse reaction reports of ANY medication currently on the market, works directly in your brain to ease nicotine withdrawal symptoms.
The main ingredient in Chantix, varenicline, causes the release of dopamine within your brain while blocking nicotine from occupying your alpha 4 beta 2 receptors. Many antipsychotic drugs block dopamine receptors, but they’re also known to cause movement disorders. (For example, the loss of muscle control seen in Parkinson's disease is the result of the destruction of dopamine-producing cells in your brain.)
Now, your alpha 4 beta 2 receptors play numerous roles in your brain and body, and are central to muscle contractions. This includes both voluntary movement, and involuntary muscle contractions such as your heart muscle, and the smooth muscles that line your blood vessels.
So not only does Chantix decrease your ability to feel pleasure (by blocking your pleasure centers), which can lead to severe depression, but it can also wreak havoc with your heart and cardiovascular health.
According to ISMP, "These data provide a strong signal that the risks of varenicline [Chantix] treatment have been underestimated, and show that a wide spectrum of serious injuries are being reported in large numbers."
Honestly, is it really worth it?
The Quitting Method Proven MOST Effective is Also HARMLESS
Nearly all quitting method surveys to date show that, long-term, cold turkey quitters actually do better than users of nicotine gum, anti-smoking patches, lozenges, and anti-smoking drugs.
For example, a 2006 National Cancer Institute quitting method survey of 8,200 smokers found that after 9 months, 16 percent of people who quit on their own were still smoke-free, compared to 14 percent among quitters relying upon the nicotine patch, gum, lozenge, or Zyban (another anti-smoking drug linked to suicides and seizure deaths).
With side effects this numerous and serious, it’s astounding that this drug is pushed on otherwise healthy people for a problem that has been proven “fixable” without medical intervention whatsoever.
How to Make Quitting ‘Cold Turkey’ Easier
I have long supported the recommendation that smoking cessation should be delayed until you have had an opportunity to optimize your diet as this will accomplish two things. First, it will help decrease your risk of potential depressive complications, and secondly, feeling healthier can help motivate you to quit smoking for good.
Removing sugars and grains, and being certain to have balanced fatty acids like fish oil in your diet, will go a long way toward preventing the depression that frequently strikes when you first quit smoking.
If depression does become an issue, omega-3 fatty acids have been found to naturally ease depression. I recommend using krill oil to optimize your omega-3 intake. For more details on the link between omega-fats and depression, I highly recommend the book, "The Omega-3 Connection."