36 lots of losartan potassium and losartan potassium/hydrochlorothiazide have been initiated by Torrent Ltd Pharmaceuticals due to a detection of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). NMBA, according to Toronto Research Chemicals, is a known carcinogen in a wide range of animal species. There have been no reports of users becoming ill and the recall is being done out of precaution.

N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) was the third chemical detected resulting in the latest two recalls of losartan, an angiotensin receptor blocker commonly used to treat hypertension (high blood pressure).  It is believed to have been created during the manufacturing process of the generic drug.

The FDA reports:

TORRENT PHARMACEUTICALS LIMITED IS FURTHER EXPANDING ITS VOLUNTARY RECALL TO INCLUDE 104 ADDITIONAL LOTS OF LOSARTAN POTASSIUM AND LOSARTAN POTASSIUM/HYDROCHLOROTHIAZIDE COMBINATION TABLETS. THIS RECALL IS DUE TO UNACCEPTABLE AMOUNTS OF N-NITROSO-N-METHYL-4-AMINOBUTYRIC ACID (NMBA) IN THE LOSARTAN ACTIVE PHARMACEUTICAL INGREDIENT (API) MANUFACTURED BY HETERO LABS LIMITED.
THE AGENCY UPDATED THE LIST OF LOSARTAN PRODUCTS UNDER RECALL ACCORDINGLY.
FDA REMINDS PATIENTS TAKING RECALLED ANGIOTENSIN II RECEPTOR BLOCKERS (ARBS) TO CONTINUE TAKING THEIR CURRENT MEDICINE UNTIL THEIR PHARMACIST PROVIDES A REPLACEMENT OR THEIR DOCTOR PRESCRIBES A DIFFERENT MEDICATION THAT TREATS THE SAME CONDITION.
FDA IS ALSO POSTING NEW TESTING METHODS WHICH CAN HELP MANUFACTURERS AND INTERNATIONAL REGULATORS DETECT AND IDENTIFY MULTIPLE NITROSAMINE IMPURITIES. FDA AND INTERNATIONAL REGULATORS HAVE IDENTIFIED N-NITROSODIMETHYLAMINE (NDMA), N-NITROSODIETHYLAMINE (NDEA) AND NMBA IN ARBS.

Earlier this Fall, ScieGen Pharmaceuticals, Inc. recalled certain lots of irbesartan, a similar angiotensin receptor blocker used in blood pressure management.

The recalls initially began last summer when FDA recalled a number of lots of valsartan due to an “impurity,” N-nitrosodimethylamine (NDMA) that is known to cause cancer in animals.  Weeks later they additionally found traces of N-nitrosodiethylamine (NDEA).

According to Reuters, earlier last summer, the MHRA, Medicines and Healthcare Products Regulatory Agency, located in the UK, said the appearance of the impurity, NDMA, came after a change in the process for making valsartan at one facility owned by Zhejiang Huahai Pharmaceuticals, a company in Linhai, China.

In animals, NDMA is known to cause liver and lung cancer.  In humans its carcinogenic risk is unknown, however the CDC states it may cause liver function impairment and cirrhosis.

With NDEA, data is limited, but due to its classification as a nitrosamine and its prevalence in tobacco smoke it is classified as a probable human carcinogen.

According to New Jersey Department of Health’s website, NDEA has been linked to liver, lung and gastrointestinal tract cancer in animals.

Losartan, valsartan and irbesartan are medications in the class of angiotensin receptor blockers (ARBs) used for high blood pressure and congestive heart failure.

Those taking either tablet for their blood pressure are urged to not abruptly stop their medication but rather check with their medical provider and pharmacy to see if their particular prescription is involved in the recall.

I suspect more recalls will follow as processes may be similar across multiple pharmaceutical facilities and NMBA, NDMA and NDEA are byproducts that may not be individually unique to just one “brand” of medication manufacturing.

 

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Daliah Wachs is a guest contributor to GCN news, her views and opinions, medical or otherwise, if expressed, are her own. Doctor Wachs is an MD,  FAAFP and a Board Certified Family Physician.  The Dr. Daliah Show , is nationally syndicated M-F from 11:00 am - 2:00 pm and Saturday from Noon-1:00 pm (all central times) at GCN.

 

 

Published in Health

At least one in three adults has high blood pressure and strokes are the 5th leading cause of death in the United States.

In May we raise awareness of both these conditions during American Stroke Monthand National High Blood Pressure Education Month.

Every 40 seconds, someone in the United States suffers a stroke.  And high blood pressure puts one at risk of a stroke, as well as heart disease.

Here are your questions answered.

 

Risk-Factors-For-Heart-Disease-High-Blood-Pressure-700x395-700x395.jpg

 

What do the blood pressure numbers mean?

 

The top number, or systolic pressure, is the pressure the heart exudes during a beat or pumping of the blood.

Diastolic pressure is the pressure in your arteries between beats while the heart is “filling.”

Both numbers are equally important as elevation of either can increase one’s risk of cardiovascular disease.

What blood pressure level is considered “normal” or “abnormal?”

 

High blood pressure has now been redefined as being greater than 130/80 mmHg, down from 140/90 mmHg.   Last year it was guestimated that 42% of Americans would soon be considered “hypertensive.”

 

blood+pressure+chart

 

What can long-term high blood pressure cause?

 

Chronic high blood pressure can be dangerous.  It may cause:

  • Heart attacks
  • Heart failure
  • Stroke
  • Kidney disease
  • Dementia
  • Eye damage – vision loss
  • Erectile dysfunction…to name a few.

How do we treat high blood pressure?

 

The stages of blood pressure are defined in the chart above.  At the elevated or early stages of high blood pressure the following lifestyle changes will be recommended:

  • Weight loss
  • Low salt diet
  • Low fat diet
  • Good sleep habits
  • Regular exercise
  • Avoiding tobacco products
  • Limiting alcohol consumption

As a family physician I would also screen for diabetes, high cholesterol, low thyroid, kidney disease and sleep apnea.

If blood pressure cannot be controlled and continues to rise, medications may be prescribed to decrease blood volume, or lower the heart rate, or relax the blood vessels.

 

What is a stroke?

 

A stroke occurs when an area of the brain does not get the proper oxygen and blood flow it needs. There are two major types of stroke:  ischemic and hemorrhagic.

Ischemic strokes are more common than the latter and occur when a clot prevents blood flow to part of the brain.  80% of all strokes fall under ischemic.  It is a likened to a heart attack, except the brain tissue is being deprived of blood and nutrients. Plaques commonly arise from arteriosclerosis that break off travel to the smaller vessels of the brain.

Hemorrhagic strokes are less common and occur when there is a bleed of one of the brain vessels.  The bleed prevents blood flow into the brain since it is seeping outside the brain tissue, causing damage to nearby cells.  The bleeds could occur from high blood pressure or aneurysms that rupture.

What are the signs of a stroke?

Since a clot or bleed usually affect one area of the brain, we see symptoms on one side of the body, many times its contralateral (opposite) side.  We can also see central effects.  The symptoms of stroke include the following:

  • Weakness of one side of the body
  • Loss of balance
  • Numbness on one side of the body
  • Slurred speech
  • Vision issues
  • Headache
  • Facial droop

and more…..

How are strokes treated?

 

If the stroke was caused by a clot (ischemic) immediate treatment includes dissolving/removing the clot.  Aspirin is used initially and if within the proper time frame, tissue plasminogen activator (TPA).  These clots can also be surgically removed and arteries widened to bring blood flow to the brain.

With a hemorrhagic  stroke, we need to stop the bleed and improve flow to the brain.  Controlling the bleed, bypassing the vessel, “clogging” the aneurysm with techniques such as “coiling” (endovascular embolization) are sometimes utilized.

Time is of the essence, so it's crucial to identify the warning signs and call 911 immediately.  The American Stroke Association uses the acronym “FAST” (Facial drooping, Arm weakness, Speech difficulty, and Time to call 911).  The sooner a stroke victim receives medical attention the better the prognosis.

 

 

fast

COURTESY OF THE AMERICAN STROKE ASSOCIATION

 

What are the risk factors for stroke?

 

The following put us at risk of having a stroke.

  • High blood pressure
  • Family history of stroke
  • Diabetes
  • Cardiovascular disease (artery clogging, such as the heart and carotid arteries)
  • Abnormal heart rhythms, such as atrial fibrillation
  • Smoking
  • Drugs
  • Obesity
  • Inactivity
  • Clotting disorder
  • Sleep apnea
  • Being older (greater than 55)
  • African-Americans appear to be more at risk than Caucasians and Hispanics
  • Men seem to be more affected than women

 

How do we prevent strokes?

 

Avoid the following:

  • Excessive drinking
  • Drug use
  • Tobacco products
  • Control blood pressure, sugar and cholesterol
  • Get evaluated by a medical provider if at risk for heart disease or stroke.

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Daliah Wachs is a guest contributor to GCN news. Doctor Wachs is an MD,  FAAFP and a Board Certified Family Physician.  The Dr. Daliah Show , is nationally syndicated M-F from 11:00 am - 2:00 pm and Saturday from Noon-1:00 pm (all central times) at GCN.

 

 

Published in Health

Hypertension is the measured change in pulse and resting phase pressure in the peripheral circulation. The heart is pumping against blood vessels, that should respond to the heart. In a healthy circulatory system, blood vessels provide about three quarters of the pump action moving blood, oxygen and nutrients to peripheral tissues. All of the blood flow back to the heart results for the peristaltic wave of contraction of veins back to the right side of the heart. The right heart only pumps to the lung fields to pick up oxygen.

To lower blood pressure we must improve blood vessel secondary wave of contraction, and support mitochondrial metabolism that makes up three quarters of the muscular middle layer, responsible for flow. To lower blood viscosity is essential, reduce free radicals that make vessels stiff with oxidized plaque from fatty acids and cholesterol that has be damaged. Singlet oxygen radical, hydrogen peroxide radical, and nitroperoxide radicals must be quenched. A byproduct of inadequate methyl group transfer from folate, B12, and methyl group deficiency is homocysteine which must be reduced to prevent vessel wall injury.  Cholesterol is not dangerous to the artery, but small particle HDL and VLDL3 can be swallowed by macrophages and die becoming plaque forming foam cells. They release local molecules that can cause fibrin and platelets to aggregate like tar on a shack.

Do not take cholesterol lowering drugs as these reduce myelin in the brain, lower adrenal and sex hormone levels, and can cause reduced cardiac Coenzyme Q10, the spark of heart conduction. You must take a functional medical support formulas that balance all the above while not causing harm. Lower blood viscosity, while reducing plaque, without blood blocking drugs that can cause catastrophic bleeding.  To lower blood pressure requires an orchestra of molecules, including non-crystallizing unique CoQ10, heavy metals and free iron reducers, free radical blockers, anti-inflammatory fatty acids EPA/DHA without solvents or heavy metals, and mitochondrial contractile support of heart and most importantly blood vessel to maintain and improve tissue perfusion. For a FREE protocol for hypertension, or any other medical and  or anti-aging issue contact Dr. Bill --  This email address is being protected from spambots. You need JavaScript enabled to view it. or tune in M-F to the NutriMedical Report (2-5pm Central) live on GCN; our call in line is 877-317-6432.

Be Well, 

 

Dr. Bill. 

 

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Doctor Bill Deagle is a guest contributor to GCN news. His views and opinions, if expressed, are his own. Doctor Deagle, MD, is a member of The American Academy of Emergency Medicine, The American College of Sports Medicine and The American Anti-Aging Association. His radio program, The Nutrimedical Report, is nationally syndicated live, M-F (2:00 pm - 5:00 pm - central time) at GCN. Dr. Bill's array of nutraceuticals are available at www.nutrimedical.com.  

 

 

Published in News & Information

High blood pressure has now been redefined as being greater than 130/80 mmHg, down from 140/90 mmHg. This will mean close to 103 million more Americans will fall under the “hypertensive” category.

 

Multiple agencies, including the American Heart Association and American College of Cardiology, redefined the guidelines, in practice for the last 14 years, to lower the threshold for high blood pressure from 140/90 to 130/80.

 

Under the old guidelines, 1/3 of US Americans were considered to have high blood pressure.  Now 42% of Americans will be “hypertensive.”

 

In lowering the guidelines, task force members hope to reduce complications associated with high blood pressure and start treatment earlier in those who have not been treated.

 

blood+pressure+chart

 

What do the blood pressure numbers mean?

 

The top number, or systolic pressure, is the pressure the heart exudes during a beat or pumping of the blood.

 

Diastolic pressure is the pressure in your arteries between beats while the heart is “filling.” Both numbers are equally important as elevation of either can increase one’s risk of cardiovascular disease.

What can long term high blood pressure do?

 

Chronic high blood pressure can be dangerous.  It may cause:

 

  • Heart attacks

  • Heart failure

  • Stroke

  • Kidney disease

  • Dementia

  • Eye damage – vision loss

  • Erectile dysfunction…to name a few.

How do we treat high blood pressure?

 

The stages of blood pressure are defined in the chart above.  At the elevated or early stages of high blood pressure the following lifestyle changes will be recommended:

 

  • Weight loss

  • Low salt diet

  • Low fat diet

  • Good sleep habits

  • Regular exercise

  • Avoiding tobacco products

  • Limiting alcohol consumption

  • As a family physician I would also screen for diabetes, high cholesterol, low thyroid, kidney disease and sleep apnea.

  • If blood pressure cannot be controlled and continues to rise, medications may be prescribed to decrease blood volume, or lower the heart rate, or relax the blood vessels.



----

Daliah Wachs is a guest contributor to GCN news. Doctor Wachs is an MD,  FAAFP and a Board Certified Family Physician.  The Dr. Daliah Show , is nationally syndicated M-F from 11:00 am - 2:00 pm and Saturday from Noon-1:00 pm (all central times) at GCN.

 

Published in News & Information