By Dr. Mercola
Recent news again highlights why you'd be well advised to heed early warnings about potentially dangerous drugs.
The first featured article reports that the US Food and Drug Administration (FDA) is now investigating a potential link between a commonly used class of diabetes drugs and pancreatic inflammation and pre-cancerous changes to the pancreas.1
The FDA is also adding a heart-risk warning to the antibiotic Zithromax (azithromycin), better known as the Z-Pak.2
I've discussed the dangers of Zithromax before, most recently in December last year, and warned of potential dangers of Januvia all the way back in 2006 — the same drug now being investigated by the FDA for a potential link to pancreatic cancer. I also published a strong warning against this class of drugs last year.
In each case, I presented the evidence against the drugs long before any warnings were issued by the FDA, or action was taken to remove the dangerous drugs from the market.
In the case of Vioxx, my warnings preceded the drug's eventual removal by five years, but it was too late as the drug had already killed over 60,000 people.
I have no doubt that these newer diabetes drugs will kill tens of thousands of people from cancer before action is taken. There is a good chance the death toll will even exceed that from Vioxx. Hopefully, you or someone you love will not be one of the victims, as you will have this potentially life-saving information.
"Want of foresight, unwillingness to act when action would be simple and effective, lack of clear thinking, confusion of counsel until the emergency comes, until self-preservation strikes its jarring gong - these are the features which constitute the endless repetition of history." ~ Winston Churchill
FDA Investigates Potential Cancer Link to Popular Diabetes Drugs
According to an FDA notice,3 posted on March 14, the agency is:
"Evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics. These findings were based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes."
This class of diabetes drugs, known as incretin mimetics, includes:
Exenatide (Byetta, Bydureon)
Sitagliptin (Januvia, Janumet, Janumet XR, Juvisync)
Saxagliptin (Onglyza, Kombiglyze XR)
Alogliptin (Nesina, Kazano, Oseni)
Linagliptin (Tradjenta, Jentadueto)
Incretin mimetics (also known as glucagon-like peptide-1 receptor agonist, or GLP-1 agonist, and dipeptidyl peptidase-4 inhibitors, or simply DPP-4 inhibitors), work by mimicking incretin hormones, reducing glucagon levels, and inhibiting the enzyme called DPP-4.
Incretins are a group of gut hormones your body produces naturally to stimulate the release of insulin in response to a meal. So, as your blood sugar rises, the drug prompts your pancreas to release insulin. It also prevents your pancreas from putting out too much glucagon, another hormone, which causes your liver to release stored sugar into your bloodstream.
Another mechanism by which it helps control your blood sugar level is by inhibiting DPP-4 — a protease (an enzyme that chops up protein chains) that, among other things, destroys the hormone GLP-1, which may explain why these drugs appear to be linked to increased cancer risk. (I'll discuss this more below.)
The medication also slows the rate at which your stomach empties after you've eaten a meal, which may reduce feelings of hunger. This dampens the rate at which your blood sugar rises after eating.
The first drug in this class — Sitagliptin, manufactured by Merck and sold under the name Januvia4, 5 — received FDA approval in 2006.6 It is one of the most commonly prescribed drugs for diabetes, which is why it will have such a devastating effect if it not stopped soon. Saxagliptin (Onglyza), another DPP-4 inhibitor, was approved in July 2009, followed by Linagliptin (Trajenta) in 2011. A number of additional DPP-4 inhibitors are currently under development, including a potentially disastrous once-a-week version.
Other Cancer Links Found, Which are Not Addressed by the FDA
The fact that this class of drugs could have a damaging effect on your pancreas was already known. In fact, one of the known side effects listed on the "Warnings and Precautions" section of the drug label is acute pancreatitis. According to a study7 published on February 25 in the journal JAMA, exenatide or sitagliptin doubled the risk of developing acute pancreatitis.
What's "new" (at least to the FDA) is that these drugs may also cause pancreatic duct metaplasia (pre-cancerous cellular changes). However, previous research has not only indicated a pancreatic cancer risk with these drugs, they've also indicated a connection of thyroid, colon, melanoma, and prostate cancer! Dr. Ron Rosedale first made me aware of this connection. He is a pioneer in the natural cure of diabetes and knew this years ago because he reviewed studies like the following:
- A 2006 study8 found that "the use of DPP-4 inhibitors together with GLP-2 led to increased proliferation as well as elevated migratory activity. Therefore, the use of DPP-4 inhibitors could increase the risk of promoting an already existing intestinal tumor and may support the potential of colon cancer cells to metastasize"
- One 2008 study9 found that DPP-4 inhibitors may proteolytically inactivate local mediators involved in gliomagenesis (the formation and development of brain tumors). Another study published that same year10 linked the drug to prostate cancer
- In 2010,11 researchers concluded that "although the data on the effects of DPP-IV inhibitors in humans are scarce, the increased risk of infections and the tendency towards a higher incidence of some tumors fall in line with experimental evidence suggesting the possibility of their adverse immunological and oncological effects"
- According to a 2011 study in the journal Gastroentorology:12, 13 "data are consistent with case reports and animal studies indicating an increased risk for pancreatitis with glucagon-like peptide-1 based therapy. The findings also raise caution about the potential long-term actions of these drugs to promote pancreatic cancer, and DPP-4 inhibition to increase risk for all cancers"
- Earlier this year, researchers warned14 DPP-4 "is implicated in regulation of malignant transformation, promotion and further progression of cancer, exerting tumor-suppressing or even completely opposite - tumor-promoting activities"
This study indicates the need for exploring the cause and the importance of the disturbances in the serum DPP-4 activity and in the CD26 expression on immunocompetent cells in complex molecular mechanisms underlying the development and progression of melanoma. Significant decline in serum DPP-4 activity found in melanoma patients compared to healthy controls might indicate its possible role in development and progression of melanoma, but further research needs to be done in order to fully elucidate the cause and the importance of observed changes in DPP-4 activity.
The reason why incretin mimetic drugs appear to be associated with increased risk for a number of different cancers might be due to the following, which you're unlikely to hear from your doctor: DPP-4 is a tumor suppressor,15 so by inhibiting DPP-4 — which these drugs do — you are continuously inhibiting one of your body's natural cancer suppressing mechanisms. According to Januvia's drug information, the drug inhibits the DPP-4 enzyme for 24 hours, and you take it daily. So you are effectively permanently blocking the activity of a tumor suppressor gene.
Yet none of the safety studies on Januvia addressed its impact on tumor growth! What I find interesting is that the FDA's investigation was launched after pancreatic tissue samples were taken from patients who died from "unspecified causes," opposed to some identified pancreatic issue. So I guess there's still room for additional issues associated with these drugs...
Beware — Novel Combo Drug Will Likely Increase Both Cancer AND Heart Failure
Remarkably, Merck has indicated that the once-a-week version of the DPP-4 inhibitor being developed is also being tested in combination with certain statin drugs, such as Lipitor and Simvastatin. The reasoning for these drug combinations is that diabetics fall under the guidelines of being statin candidates because they have a higher cardiovascular risk, but 40 percent of diabetics don't take them. The idea is to create a combination drug containing both a DPP-4 inhibitor and a statin.
So they're combining two hazardous drugs into one pill that synergistically will radically increase your risk of cancer AND heart failure! These are very common side effects from these drugs when taken individually, but what has not even been studied is the synergistic toxicity of taking these dangerous drugs together.
It's sheer madness in a pill... What makes it all the more frustrating is that pharmaceutical companies are raking in the profits from these dangerous drugs when type 2 diabetes is one of the easiest diseases to address without ANY drugs. Merck, for example, made an astounding $6 BILLION in combined sales for Januvia and Janumet last year alone, making these drugs the company's top sellers.
FDA Adds Heart-Risk Warning to Z-Pak
Earlier this month, the FDA also announced it is adding a new warning to the label of Zithromax, a very potent antibiotic used to treat bronchitis, pneumonia and other serious infections, including sexually transmitted diseases. Or at least it should be reserved for serious infections. It's widely overused, which is troubling for several reasons. First of all, the new warning states that the drug can cause deadly heart arrhythmias. The FDA warns that:
"Doctors should consider prescribing other antibiotics to patients at risk of heart problems, including those with irregular heartbeats or low levels of potassium or magnesium in their blood."
The popularity of Zithromax is driven by the fact that you don't have to take it for as many days as other, less potent antibiotics — a regular course is only five days, compared to 10 days for most others. But therein lies another problem. Overuse of potent antibiotics drives the rapid rise in antibiotic-resistant bacteria, and renders the drug useless for more serious infections. According to the FDA, an astounding average of 50 million prescriptions for Zithromax are filled each year.
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Risks Associated with Z-Pak You Need to Know
"...[T]he FDA warned it could be dangerous for some people and urged everyone to understand the risks... The new drug label follows a Vanderbilt University study released in May showing a slightly higher chance for deadly heart problems in patients taking the drug. Researchers analyzed health records and data from millions of prescriptions for several antibiotics given to about 540,000 Tennessee Medicaid patients from 1992 to 2006. The highest risks were in Zithromax patients with existing heart problems," according to MSN News:16
"The results suggested there would be 47 extra heart-related deaths per 1 million courses of treatment with Zithromax, compared with another antibiotic, amoxicillin."
The study in question, published in the New England Journal of Medicine17 found that azithromycin increases your chances of dying from a cardiovascular event by 250 percent within the first five days of usage, compared to those who took amoxicillin. This is nearly the same as that for Vioxx, which killed 60,000 people and was voluntarily removed from the market nearly eight years ago. When researchers looked at people who already had heart problems, their risk of dying while on this drug were even higher. The risk of cardiovascular death was also significantly greater with azithromycin than with ciprofloxacin, while levofloxacin and azithromycin had comparable risks of cardiovascular death. Other known side effects of the Z-Pak include skin rashes, itching, severe, watery diarrhea, and severe allergic or anaphylactic reactions. If you take a statin drug, you may also experience more severe side effects, such as myopathy―muscle and tendon pain, weakness and cramping.18
The primary problem here though appears to be related to using the drug acutely. So if you took the drugs months or years ago there is nothing to worry about as the increased risk of causing this heart rhythm abnormality has eventually disappeared. However the disruption to your ever important gut flora could last many years or even decades unless you take aggressive efforts to reverse the damage.
While not stated anywhere on the drug label, all antibiotics, and especially the more potent ones like the Z-Pak, decimate your gut flora, which in turn leaves you with a sorely weakened immune system until the beneficial bacteria in your gut has time to repopulate. Ideally it would be wise to eliminate sugars and regularly use fermented foods or a high-quality probiotic supplement to restore your normal gut flora.
Remember, antibiotics should only be taken when absolutely necessary, almost a life and death scenario. If, for whatever reason, you do choose to use them it is crucial to rebalance your intestinal flora to prevent long-term effects to your health. Typically this results in an overgrowth of yeast, fungi and pathogenic organisms, which can persist for years or decades unless you carefully address the damage. Taking probiotics while on an antibiotic can also help reduce diarrhea, which is a common side effect. Saccharomyces boulardii is beneficial yeast that is not killed by antibiotics so it can actually be taken while you are on the antibiotics.
Do You REALLY Need a Drug?
In more recent years, a growing body of research shows that simple lifestyle changes such as diet and exercise are effective remedies for many common health problems. At the same time, we're seeing more and more evidence of the lethal harm being brought by poorly tested drugs.
To me, the choice is clear. But a lot of people still do not realize just how effective lifestyle changes can be in treating their disease. Many diabetics, for example, are convinced they need drugs, and resist the idea that treating or even curing their disease is entirely within their own control. The truth is, type 2 diabetes is virtually 100 percent avoidable and treatable entirely without drugs. If you're still in the dark about how to accomplish this, please see this link.
Similarly, many are quick to ask for an antibiotic, even in cases where antibiotics are useless, such as for viral infections. The temptation is to opt for a potent antibiotic to resolve the infection as quickly as possible, but this can have very serious ramifications, from decreasing your immune function for an extended period of time, to contributing to the rise of antibiotic-resistance. The Z-Pak is a great antibiotic, but if used inappropriately, it may no longer work when you really need it.
If you absolutely need to use an antibiotic, use the least potent one that is appropriate for the infection, and make sure to reseed your gut with beneficial bacteria.
Your best bet is to eat plenty of fermented foods, such as fermented vegetables, each day. Each mouthful of fermented food can provide trillions of beneficial bacteria — far more than you can get from a probiotics supplement, which will typically provide you with colony-forming units in the billions.
Last year, my team started testing fermented vegetables produced with our probiotic starter culture to determine their probiotic potency and we were astounded to discover they had 10 trillion colony-forming units of bacteria. Literally, one serving of vegetables was equal to an entire bottle of a high potency probiotics. Another really novel additional benefit is that it also produces very high levels of vitamin K2, nearly 500 mcg. We are currently in the midst of doing very sophisticated and expensive DNA sequencing analysis to optimize this starter culture formula and hope to be able to launch it later this year.