Why Did the FDA Approve a Generic Version of this Dangerous Drug?
September 06, 2012
By Dr. Mercola
Actos – the brand name for a drug used to treat type 2 diabetes – is presently embroiled in thousands of lawsuits alleging that the drug causes severe side effects including heart failure, macular edema and bladder cancer.
Even so, the U.S. Food and Drug Administration (FDA) has gone ahead and approved Mylan Lab's plan to sell a generic version of this dangerous drug (pioglitazone), justifying their reasoning by saying this gives patients “affordable treatment options.”
The FDA addressed the heart failure and bladder cancer possibilities with a recommendation that doctors carefully monitor patients taking the new generic version... however, what the new generic drug really does is expose even more people to this drug class’ unacceptable, and sometimes deadly, side effects – to treat a disease that responds very well to dietary and exercise changes!
Actos and its Generic Riddled With Serious Health Risks
Actos works by helping to control blood sugar levels in people with type 2 diabetes, a method that “experts” say will help to reduce the long-term health complications of diabetes and keep the disease under control.
But diabetes treatments concentrating merely on lowering blood sugar can actually worsen, rather than remedy, the underlying metabolic dysfunction that is at the root of type 2 diabetes. And along with completely ignoring the underlying reasons why the diabetes developed in the first place, Actos carries some very serious health risks.
For starters, Actos has a Boxed Warning that states the drug may cause or worsen heart failure.
This risk has been somewhat overshadowed by the attention given to Avandia, a similar diabetes drug in the same class that has been found to cause a 43 percent increased risk of heart attack, and a 64 percent higher risk of cardiovascular death, compared to patients treated with other methods.1 However, although Actos is regarded as a “safer” option for your heart than Avandia, it also poses serious risks to your heart.
And that’s not all.
Actos’ label also notes that the use of pioglitazone for more than one year may be associated with an increased risk of bladder cancer. In fact, new research just out from the Perelman School of Medicine at the University of Pennsylvania shows that people who take this drug for five years or more are two to three times more likely to develop bladder cancer than those who take a different form of diabetes drug.2
Actos has already been removed from the market in both Germany and France due to the bladder cancer risks... but in the United States we now have not only Actos, but a generic version as well!
In a twist to the story, two days before the FDA approved Mylan's generic Actos, Watson Pharmaceuticals sued the FDA for not following through on giving Watson exclusivity for its generic version of Actos, which was originally scheduled to be released on August 17.
There are as many as 13,000 Actos lawsuits currently pending, related to both heart failure and bladder cancer cases, as well as other side effects including bone fractures and lactic acidosis.
Actos Whistleblower Reveals Fraud, Deception and Serious Dangers
Dr. Helen Ge worked for Takeda (Actos’ maker) in the company's pharmacovigilance division. There, Dr. Ge was in charge of reviewing side effects of Actos that were reported by patients and doctors. She then prepared safety reports that were filed with the FDA – reports that Ge says she was ordered to water-down or not report at all, so Actos would look safer than it actually was.
She believes Actos is even more dangerous than Avandia, the diabetes drug mentioned earlier that has been removed from pharmacies because of the risk of heart attacks. Dr. Ge says that besides bladder cancer and tumors Actos is also connected to heart attacks and stroke, suicide, schizophrenia, homicidal ideation, and renal failure.
Dr. Ge filed her lawsuit in September 2011, alleging that Takeda, like many pharmaceutical companies, was interested in protecting their profits, first and foremost, which makes the approval of a generic version of this drug all the more unsettling. Actos is Takeda's most profitable drug, bringing in $3.4 billion in annual sales.
Dr. Ge noted:3
"Takeda's motivation to fraudulently report and under-report the serious adverse events was driven by an economic desire to falsely enhance Actos's safety profile and to increase sales."
So far Avandia has been the poster child for what is wrong with drug treatment of type 2 diabetes. And it took nearly 10 years of the drug being on the market for the FDA to take action and restrict access to this dangerous drug. In the meantime, millions of people have taken Avandia and have been exposed to these unacceptably high-risk side effects, for a drug that in no way treats the underlying causes of diabetes.
More than 80,000 diabetics have suffered from strokes, heart failure or other complications including lethal heart attacks from this dangerous drug... and now it appears Actos and its generic versions may be stepping in to fill its shoes.
What You Should Know About Diabetes Drugs...
Drugs can't cure diabetes, as they do nothing to address the underlying causes. Drugs like Actos and Avandia work by tricking diabetes patients’ bodies to become more sensitive to their own insulin, helping to control blood sugar levels. Tricking the body in non-ancestral and time-honored ways in which our biochemistry and genetics have adjusted to for many eons typically results in devastating effects eventually if pursued long enough, and the Actos and Avandia experience confirms this.
But it is important to understand that diabetes is NOT strictly a blood sugar disease like your doctor may have led you to believe. Type 2 diabetes is actually a disease caused by insulin resistance and faulty leptin (a relatively recently discovered hormone produced by fat) signaling, both of which are regulated through your diet.
Conventional treatment, which is focused on suppressing the symptom of elevated blood sugar rather than addressing the underlying causes, is doomed to fail in most cases.
Because type 2 diabetes arises from faulty leptin and insulin signaling it is therefore a fully preventable condition that can be controlled or reversed by recovering your insulin and leptin sensitivities. However, the only known long-term effective way to reestablish proper leptin and insulin signaling is through proper diet and exercise. There is NO drug that can safely accomplish this – a fact that makes the current disease paradigm even more tragic, as diabetes continues to skyrocket, and the conventional treatments are needlessly killing diabetics prematurely.
If you have type 2 diabetes, I strongly suggest that you consult with a health care practitioner who is knowledgeable about its true underlying cause, and who can work with you to reverse the condition without the use of drugs. Some of the most helpful guidelines to successfully do this include:
- Severely limit or eliminate sugar and grains in your diet, especially fructose, which is far more detrimental than any other type of sugar. Following my Nutrition Plan will help you do this without too much fuss.
- Exercise regularly. Exercise is an absolutely essential factor, and without it, you're unlikely to get this devastating disease under control. It is one of the fastest and most powerful ways to lower your insulin and leptin resistance. I recommend including some high-intensity Peak Fitness exercises for optimal results.
- Avoid synthetic trans fats.
- Get plenty of omega-3 fats from a high quality, animal-based source, such as krill oil.
- Optimize your vitamin D levels. Recent studies have revealed that getting enough vitamin D can also have a powerful effect on normalizing your blood pressure, which has virtually identical response improvement to diabetic interventions.
- Optimize your gut flora. Your gut is a living ecosystem, full of many different types of bacteria. The more beneficial bacteria you have, the more likely your blood sugar will be in balance. Indeed, new research published in the journal Lipids in Health and Disease found that a combination of prebiotics and probiotics, taken for 30 days, resulted in a significant reduction in fasting blood sugar in human subjects.4
Fortunately, optimizing your gut flora is relatively easy. You can reseed your body with good bacteria by eating fermented foods (like natto, kefir, raw organic cheese, miso, and fermented vegetables) or by taking a high-quality probiotic supplement.
- Address any underlying emotional issues and/or stress. Non-invasive tools like the Emotional Freedom Technique (EFT) can be extremely helpful and effective.
- Get enough high-quality sleep every night.
- Monitor your fasting insulin level. This is every bit as important as your fasting blood sugar. You'll want your fasting insulin level to be between 2 and 4. The higher your level, the worse your insulin sensitivity is.