Here is the link and the article:
http://blueheronhealthnews.com/site/?p=6135
This FDA Drug Recall Should Frighten You
If you’re taking any kind of prescription medication or if your doctor is pushing you to take medications, a recent FDA recall should really make you think twice.
I don’t like writing negative, frightening articles. But this issue is too serious to ignore.
Here’s why. More than five years after the FDA was made aware of this drug being completely useless while at the same time causing serious side effects (even deaths) the drug was still on the market.
… and worst of all, it had NEVER BEEN TESTED!
That’s right. This particular drug had never gone through the FDA’s regular approval process. No study had ever been done to test the effectiveness of this drug. Yet it had the FDA’s stamp of approval based on nothing more than faith.
What was the drug and how did this happen? That’s the issue of today’s feature article.
The drug in question was the 300mg generic version of Wellbutrin XL, which is manufactured by Impax Laboratories and marketed by Teva Pharmaceuticals. But the problem isn’t just this particular drug. It’s how the FDA handled the whole approval and recall process. And any kind of drug you’re taking can be handled in the same way.
You see, for a long time the FDA has been favorable towards generic drugs. These are drugs that should include a formula similar to what’s found in the big brand medications that have gone through extensive testing and been previously approved by the FDA.
Note that the generic versions are not identical, only similar. For the most part, it has to include the same active ingredients but not exactly the same and not necessarily in the same dosages. It’s similar to big brand products compared to store brands. They are mostly the same but still not identical.
So the patient is in essence used as guinea pig with the generic versions.
In this case, the 300mg generic version was a takeoff from the 150mg version of the brand name drug. And the FDA just assumed that since the 150mg worked, a 300mg version would work as well or better.
That was not the case. Immediately in 2006 after the drug was approved, the FDA began receiving complaints about its severe side effects as well as ineffectiveness.
The next step the FDA took was unforgivable. Instead of putting out a warning regarding this drug, recalling it or making their own independent tests, they asked the manufacturer to test the drug.
The manufacturer started the testing process but soon abandoned it due to “slow patient enrollment.” After all, why should they spend millions on testing a drug that was already approved and they were still selling truckloads of it every month.
If this were the 1950s, they’d have asked the tobacco companies “Please test to see if cigarettes might be dangerous.”
So four years passed, while patients suffered, and nothing happened. Finally in 2010 the FDA was forced to perform their own tests, which quickly revealed what everyone really knew. The drug was not effective and dangerous.
And yet, it wasn’t until October 2012, two months after the results came out, that the FDA revealed their mistakes to the public.
Since the FDA has approved hundreds of other drugs using the same faulty methods (assuming that a generic drug works because it’s somewhat similar to the original drug), you would think they were working day and night pulling these drugs off the market, right?
Wrong! Most of the drugs are still being prescribed. I would love to give you a list of all these drugs but that would take thousands of hours of research.
Instead the FDA has asked the drug manufacturers to test their own drugs and submit the results by March 2013. This is the exact same thing they did before, which kept this dangerous drug on the market for four more years.
Approving ineffective drugs may be even worse than having drugs with side effects. It gives people false security. And since the drug doesn’t work, your doctor will add on another drug and another drug until you’re taking 50 different drugs that don’t work and interact with each other in a negative way.
Again, I apologize for the negative tone of today’s article. I hope you’ll take the time to browse through our archive of hundreds of positive articles on this site (just click the “Articles” or “Brows By Topic” link at the top of this page). Or you may want to check out our natural health guides on the right hand side of this page.
If your doctor is suggesting you take medications for particular diseases, you’ll want to check out the following:
Simple exercises that drop blood pressure below 120/80 as soon as today…
3 step approach that reverses type 2 diabetes in 21 days…
Easy step-by-step plan that gets your cholesterol under control…
(MY INPUT):
ARE you on blood pressure medicine including but not limited to Felodipine and lisinopril?
If so read below:
http://www.drugs.com/sfx/felodipine-side-effects.html
http://sideeffectz.com/lisinoprilsideeffects/
Side effects of Lisinopril:
Common Lisinopril Side Effects: The most common side effect of all of the ACE inhibitor medications including Lisinopril is an annoying persistent cough. This resolves if the medication is stopped, but can take weeks or months to completely go away. This cough is felt to happen because the area where angiotensin 1 is converted into angiotensin 2, and the area where lisinopril and the other ACE inhibitors have their primary effect is in the lung. Other common Lisinopril side effects include those related to low blood pressure like lightheadedness and dizziness and severe hypotension. Patients may also experience diarrhea, headache, fatigue, abdominal pain, photosensitivity, and elevated serum potassium levels.
Serious Lisinopril Side Effects: Relatively common and potentially serious Lisinopril side effects are swelling of the lips, mouth or airway called angioedema. Angioedema may also occur in the bowel, and severe allergic reactions can occur. Elevated potassium, hyperkalemia, can occur and lead to cardiac arrhythmia and death. Renal impairment can occur, most often in patients with preexisting obstruction of one or both renal arteries. Bone marrow dysfunction with agranulocytosis, neutropenia, as well as liver toxicity, pancreatitis, and SIADH (syndrome of inappropriate anti-duretic hormone) can occur as Lisinopril side effects. Use in pregnancy can lead to oligohydramnios, fetal harm and death, and major fetal abnormalities if used in the first trimester of pregnancy.
When cough occurs medications in the Angiotensin Receptor Blocker (ARB) class of medications can often be substituted for the Lisinopril and resolution of the cough is expected. Reevaluation of renal function after initiation of Lisinopril is usually recommended to assure there is not a significant reduction of renal function.
Contraindications, Cautions and Drug Interactions: Lisinopril use is contraindicated in patients with a prior history of an ACE inhibitor angioedema, as well as in patients with hereditary angioedema. As mentioned above lisinopril is absolutely contraindicated in pregnancy. Caution needs to be used in institution of lisinopril in patients with volume depletion (dehydration). Careful monitoring of renal function is needed in patients with renal dysfunction, although lisinopril is often used by nephrologists to avoid further renal insufficiency. Drug interactions primarily relate to cumulative Lisinopril side effects. Use with an ARB medication can lead to hyperkalemia, and although the drugs can be used together, this needs monitoring. Azothiaprine and lithium have specific drug interaction issues. Non-steroidal anti-inflammatory medications can reduce the effectiveness of the ACE inhibitors, and are best avoided or monitored. See the manufacturer prescribing information for the long list of medications to consider, but most other medications can be used with appropriate monitoring. Some herbal medications and supplements have potential interaction with lisinopril and include black kohash and kava.
(MY INPUT) ............see link below for explanation of RENAL FUNCTION
http://en.wikipedia.org/wiki/Renal_function
YOU need TO GET OFF THE SIMPLE CARBS, GET OFF THE SUGAR, drink more water, exercise more, stop eating before you go to bed. Work with your doctor to get off the prescription drugs if you possibly can.
Dan
Psalms 103:1-4 NKJV) Bless the LORD, O my soul; And all that is within me, bless His holy name! {2} Bless the LORD, O my soul, And forget not all His benefits: {3} Who forgives all your iniquities, Who heals all your diseases, {4} Who redeems your life from destruction, Who crowns you with lovingkindness and tender mercies,
I don’t like writing negative, frightening articles. But this issue is too serious to ignore.
Here’s why. More than five years after the FDA was made aware of this drug being completely useless while at the same time causing serious side effects (even deaths) the drug was still on the market.
… and worst of all, it had NEVER BEEN TESTED!
That’s right. This particular drug had never gone through the FDA’s regular approval process. No study had ever been done to test the effectiveness of this drug. Yet it had the FDA’s stamp of approval based on nothing more than faith.
What was the drug and how did this happen? That’s the issue of today’s feature article.
The drug in question was the 300mg generic version of Wellbutrin XL, which is manufactured by Impax Laboratories and marketed by Teva Pharmaceuticals. But the problem isn’t just this particular drug. It’s how the FDA handled the whole approval and recall process. And any kind of drug you’re taking can be handled in the same way.
You see, for a long time the FDA has been favorable towards generic drugs. These are drugs that should include a formula similar to what’s found in the big brand medications that have gone through extensive testing and been previously approved by the FDA.
Note that the generic versions are not identical, only similar. For the most part, it has to include the same active ingredients but not exactly the same and not necessarily in the same dosages. It’s similar to big brand products compared to store brands. They are mostly the same but still not identical.
So the patient is in essence used as guinea pig with the generic versions.
In this case, the 300mg generic version was a takeoff from the 150mg version of the brand name drug. And the FDA just assumed that since the 150mg worked, a 300mg version would work as well or better.
That was not the case. Immediately in 2006 after the drug was approved, the FDA began receiving complaints about its severe side effects as well as ineffectiveness.
The next step the FDA took was unforgivable. Instead of putting out a warning regarding this drug, recalling it or making their own independent tests, they asked the manufacturer to test the drug.
The manufacturer started the testing process but soon abandoned it due to “slow patient enrollment.” After all, why should they spend millions on testing a drug that was already approved and they were still selling truckloads of it every month.
If this were the 1950s, they’d have asked the tobacco companies “Please test to see if cigarettes might be dangerous.”
So four years passed, while patients suffered, and nothing happened. Finally in 2010 the FDA was forced to perform their own tests, which quickly revealed what everyone really knew. The drug was not effective and dangerous.
And yet, it wasn’t until October 2012, two months after the results came out, that the FDA revealed their mistakes to the public.
Since the FDA has approved hundreds of other drugs using the same faulty methods (assuming that a generic drug works because it’s somewhat similar to the original drug), you would think they were working day and night pulling these drugs off the market, right?
Wrong! Most of the drugs are still being prescribed. I would love to give you a list of all these drugs but that would take thousands of hours of research.
Instead the FDA has asked the drug manufacturers to test their own drugs and submit the results by March 2013. This is the exact same thing they did before, which kept this dangerous drug on the market for four more years.
Approving ineffective drugs may be even worse than having drugs with side effects. It gives people false security. And since the drug doesn’t work, your doctor will add on another drug and another drug until you’re taking 50 different drugs that don’t work and interact with each other in a negative way.
Again, I apologize for the negative tone of today’s article. I hope you’ll take the time to browse through our archive of hundreds of positive articles on this site (just click the “Articles” or “Brows By Topic” link at the top of this page). Or you may want to check out our natural health guides on the right hand side of this page.
If your doctor is suggesting you take medications for particular diseases, you’ll want to check out the following:
Simple exercises that drop blood pressure below 120/80 as soon as today…
3 step approach that reverses type 2 diabetes in 21 days…
Easy step-by-step plan that gets your cholesterol under control…
(MY INPUT):
ARE you on blood pressure medicine including but not limited to Felodipine and lisinopril?
If so read below:
http://www.drugs.com/sfx/felodipine-side-effects.html
Felodipine
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Felodipine:Diarrhea; dizziness; flushing; headache; mild swelling of gums; nausea; weakness.Seek medical attention right away if any of these SEVERE side effects occur when using Felodipine:
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breathing problems; chest pain; enlarged breasts in men; fast or irregular heartbeat; heart problems; impotence; lightheadedness and fainting; swelling of the ankles or hands.This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
http://sideeffectz.com/lisinoprilsideeffects/
Side effects of Lisinopril:
Common Lisinopril Side Effects: The most common side effect of all of the ACE inhibitor medications including Lisinopril is an annoying persistent cough. This resolves if the medication is stopped, but can take weeks or months to completely go away. This cough is felt to happen because the area where angiotensin 1 is converted into angiotensin 2, and the area where lisinopril and the other ACE inhibitors have their primary effect is in the lung. Other common Lisinopril side effects include those related to low blood pressure like lightheadedness and dizziness and severe hypotension. Patients may also experience diarrhea, headache, fatigue, abdominal pain, photosensitivity, and elevated serum potassium levels.
Serious Lisinopril Side Effects: Relatively common and potentially serious Lisinopril side effects are swelling of the lips, mouth or airway called angioedema. Angioedema may also occur in the bowel, and severe allergic reactions can occur. Elevated potassium, hyperkalemia, can occur and lead to cardiac arrhythmia and death. Renal impairment can occur, most often in patients with preexisting obstruction of one or both renal arteries. Bone marrow dysfunction with agranulocytosis, neutropenia, as well as liver toxicity, pancreatitis, and SIADH (syndrome of inappropriate anti-duretic hormone) can occur as Lisinopril side effects. Use in pregnancy can lead to oligohydramnios, fetal harm and death, and major fetal abnormalities if used in the first trimester of pregnancy.
When cough occurs medications in the Angiotensin Receptor Blocker (ARB) class of medications can often be substituted for the Lisinopril and resolution of the cough is expected. Reevaluation of renal function after initiation of Lisinopril is usually recommended to assure there is not a significant reduction of renal function.
Contraindications, Cautions and Drug Interactions: Lisinopril use is contraindicated in patients with a prior history of an ACE inhibitor angioedema, as well as in patients with hereditary angioedema. As mentioned above lisinopril is absolutely contraindicated in pregnancy. Caution needs to be used in institution of lisinopril in patients with volume depletion (dehydration). Careful monitoring of renal function is needed in patients with renal dysfunction, although lisinopril is often used by nephrologists to avoid further renal insufficiency. Drug interactions primarily relate to cumulative Lisinopril side effects. Use with an ARB medication can lead to hyperkalemia, and although the drugs can be used together, this needs monitoring. Azothiaprine and lithium have specific drug interaction issues. Non-steroidal anti-inflammatory medications can reduce the effectiveness of the ACE inhibitors, and are best avoided or monitored. See the manufacturer prescribing information for the long list of medications to consider, but most other medications can be used with appropriate monitoring. Some herbal medications and supplements have potential interaction with lisinopril and include black kohash and kava.
(MY INPUT) ............see link below for explanation of RENAL FUNCTION
http://en.wikipedia.org/wiki/Renal_function
YOU need TO GET OFF THE SIMPLE CARBS, GET OFF THE SUGAR, drink more water, exercise more, stop eating before you go to bed. Work with your doctor to get off the prescription drugs if you possibly can.
Dan
Psalms 103:1-4 NKJV) Bless the LORD, O my soul; And all that is within me, bless His holy name! {2} Bless the LORD, O my soul, And forget not all His benefits: {3} Who forgives all your iniquities, Who heals all your diseases, {4} Who redeems your life from destruction, Who crowns you with lovingkindness and tender mercies,
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