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Heart Disease
Safety Concerns Over New Statin-and Diabetes Drug Concoction
Date: 06/12/11
Keywords: American Food and Drug Administration (FDA), The Cholesterol Truth, adverse side effects, Cholesterol, Diabetes Type 2, Diabetes, Kidney Problems
According to the FDA, the most common side effects of Juvisync include upper respiratory infection, stuffy or runny nose and sore throat, headache, muscle and stomach pain, constipation, and nausea.
Our regular readers, will know that muscle pain is one of the most common statin-related side effects and in the worst cases, that damage can be a precursor to kidney impairment... and believe it or not, diabetes is one of the most common causes of kidney failure.
Recently the American Food and Drug Administration (FDA)
approved a new drug, with a rather catchy name: Juvisync.
But that's where the fun stops!
Juvisync is the first drug to combine a statin (Zocor) with a type 2 diabetes drug (Januvia)... and to be honest, I can't think of a worse combination of drugs to take!
Terrible two
Now you might ask, how did this terrible combination of drugs see the light of day? Well, well, I'll let the FDA's news release explain: "The FDA has recently become aware of the potential for statins to increase blood sugar levels in patients with type 2 diabetes."
For nearly 15 years, middle-aged and older people have been taking Lipitor and other statins by the barrelful. During that time, two things happened:
1) Statins became the best-selling class of prescription drugs of all time, and
2) The number of middle-aged and older people who have developed type 2 diabetes has soared!
In fact, earlier this year on The Cholesterol Truth blog, Dr John Briffa reported on an article that appeared in the journal The Lancet involving a 2010 study, which showed that for every 225 patients taking statin drugs for longer than 4 years, one case of Type 2 diabetes occurs. To read this article, click here:
Which is probably why, now that the mainstream became aware of the link, Big Pharma saw a brilliant money-making opportunity and voila, Juvisync is their answer. So, be sure that drug companies and doctors will be trying to convince more than a few statin-taking patients to take a statin/type-2 drug combo...
Playing with fire
However, for anyone concerned with safety, Juvisync is a potential train wreck.
According to the FDA, the most common side effects of Juvisync include upper respiratory infection, stuffy or runny nose and sore throat, headache, muscle and stomach pain, constipation, and nausea.
Our regular readers, will know that muscle pain is one of the most common statin-related side effects and in the worst cases, that damage can be a precursor to kidney impairment... and believe it or not, diabetes is one of the most common causes of kidney failure.
Unfortunately, it gets worse! In 2009, the FDA warned that Januvia may increase risk of acute pancreatitis... Which is a condition no diabetic wants either. As you know, the pancreas produces insulin, but it stops doing this when acute or chronic pancreatitis occurs... and a diabetic without the correct insulin levels will find themselves in a very dangerous place.
That same year, an FDA safety review of a Zocor study also revealed that the statin successfully lowered LDL 'bad' cholesterol, BUT "artery thickness increased." Increasing artery thickness is not something you want from a drug that's supposed to improve heart health.
The FDA has ordered Merck (the maker of Juvisync) to conduct a post-marketing clinical trial, which means that if your doctor tries to push this dangerous Pharma cocktail on you, chances are that you're probably guinea pig and part of this post-marketing trial... without knowing it of course. So, you'll be far better off to tell him you'll wait for those study
Sources:
"FDA approves combination therapy Juvisync" FDA News Release, 10/7/11, fda.gov
"Sitagliptin (marketed as Januvia and Janumet) - acute pancreatitis" FDA Safety Alert, 9/25/09, fda.gov
"Follow-Up to the January 25, 2008 Early Communication about an Ongoing Data Review for Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor), Food and Drug Administration, January 2009, fda.gov Heart Disease and Stroke: Related Reading
Strokes and Heart Health: Look After Your Heart With B Complex
Stroke: Reduce Your Risk of Stroke With These Essential Supplements
Back to topJuvisync is the first drug to combine a statin (Zocor) with a type 2 diabetes drug (Januvia)... and to be honest, I can't think of a worse combination of drugs to take!
Terrible two
Now you might ask, how did this terrible combination of drugs see the light of day? Well, well, I'll let the FDA's news release explain: "The FDA has recently become aware of the potential for statins to increase blood sugar levels in patients with type 2 diabetes."
For nearly 15 years, middle-aged and older people have been taking Lipitor and other statins by the barrelful. During that time, two things happened:
1) Statins became the best-selling class of prescription drugs of all time, and
2) The number of middle-aged and older people who have developed type 2 diabetes has soared!
In fact, earlier this year on The Cholesterol Truth blog, Dr John Briffa reported on an article that appeared in the journal The Lancet involving a 2010 study, which showed that for every 225 patients taking statin drugs for longer than 4 years, one case of Type 2 diabetes occurs. To read this article, click here:
Which is probably why, now that the mainstream became aware of the link, Big Pharma saw a brilliant money-making opportunity and voila, Juvisync is their answer. So, be sure that drug companies and doctors will be trying to convince more than a few statin-taking patients to take a statin/type-2 drug combo...
Playing with fire
However, for anyone concerned with safety, Juvisync is a potential train wreck.
According to the FDA, the most common side effects of Juvisync include upper respiratory infection, stuffy or runny nose and sore throat, headache, muscle and stomach pain, constipation, and nausea.
Our regular readers, will know that muscle pain is one of the most common statin-related side effects and in the worst cases, that damage can be a precursor to kidney impairment... and believe it or not, diabetes is one of the most common causes of kidney failure.
Unfortunately, it gets worse! In 2009, the FDA warned that Januvia may increase risk of acute pancreatitis... Which is a condition no diabetic wants either. As you know, the pancreas produces insulin, but it stops doing this when acute or chronic pancreatitis occurs... and a diabetic without the correct insulin levels will find themselves in a very dangerous place.
That same year, an FDA safety review of a Zocor study also revealed that the statin successfully lowered LDL 'bad' cholesterol, BUT "artery thickness increased." Increasing artery thickness is not something you want from a drug that's supposed to improve heart health.
The FDA has ordered Merck (the maker of Juvisync) to conduct a post-marketing clinical trial, which means that if your doctor tries to push this dangerous Pharma cocktail on you, chances are that you're probably guinea pig and part of this post-marketing trial... without knowing it of course. So, you'll be far better off to tell him you'll wait for those study
Sources:
"FDA approves combination therapy Juvisync" FDA News Release, 10/7/11, fda.gov
"Sitagliptin (marketed as Januvia and Janumet) - acute pancreatitis" FDA Safety Alert, 9/25/09, fda.gov
"Follow-Up to the January 25, 2008 Early Communication about an Ongoing Data Review for Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor), Food and Drug Administration, January 2009, fda.gov Heart Disease and Stroke: Related Reading
Strokes and Heart Health: Look After Your Heart With B Complex
Stroke: Reduce Your Risk of Stroke With These Essential Supplements
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Want to know the real truth about cholesterol? Ever wondered why doctors, surgeons, hospitals, drug companies — or anyone else in the medical profession — don't tell you the shocking truth about statins? Why wouldn’t they want you to know that these cholesterol-lowering drugs come with a huge list of side-effects — including kidney failure and increased risk of stroke! Ask yourself why Big Pharma also don't want you to know that statins seriously deplete your body of Coenzyme-Q10 (CoQ10) – the vital heart nutrient that naturally PREVENTS heart attacks and strokes? To answer all these questions as well as exposing one of the biggest mainstream cons in medical history, click here |
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