Supplements Support Brain Recovery after Stroke

If you're a regular reader of Natural Health News you'll already be aware that we've written extensively about vitamins and other natural support for brain health, not only here but in our other print and on-line publications.

We don't endorse the low doses referenced in this article but we call your attention to the fact that our recommendations seem to be more prevalent in the news these days.

We suggest 2800 mcg B12 and proper thyroid support  and other select nutrients.  Other providers often use an extensive IV nutrient blend and refer to hyperbaric oxygen therapy.  Certainly I wish this had been offered to my mother, and most likely would have been available to her has she been under the care of a neurologist.

A combination of low dose B-vitamins and omega-3 fatty acids may help improve brain function in people who have suffered a stroke, according to a new study in the American Journal of Clinical Nutrition.

The new study looked at 1,748 people aged 45 to 80 with a history of heart attack, angina, or stroke. They were assigned to one of these groups:

• 56 mcg of folic acid (as 5-methyltetrahydrofolate), 3 mg of vitamin B6, and 2 mcg vitamin B12 per day,

• 600 mg of the omega 3 fatty acids, EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid), in a ratio of 2:1 per day,

• B vitamins and omega-3s, or

• placebo.

For four years, the participants continued their supplements, and their thinking (cognitive) function was assessed at the end of the study. No significant effects on brain function were found in the different supplement groups, but looking just at people who had had a stroke yielded different results. Post-stroke, people who took a combination of B-vitamins and omega-3 fatty acids were significantly less likely to score low on a test of the ability to accurately name the month, date, year, day of the week, and time of day (temporal orientation task) than those who took placebo.

While this study only found relatively slight evidence, it makes a good starting place for further research. “These results could be useful in interventions aimed at preventing cognitive decline in high-risk individuals,” said lead study author, Valentina Andreeva, of the University of Paris XIII.

An aging problem

As the world’s population continues to get older, problems related to aging also grow, including the prevalence of Alzheimer’s disease and other forms of dementia. Alzheimer’s currently affects 1 in 8 people aged 65 and older.

Advancing age is the foremost risk factor for developing dementia. Addressing other risk factors—those that you can actually do something about—might be the most effective way to prevent the disease from developing. Modifiable risk factors for dementia include

• high blood pressure (hypertension),

• obesity,

• high levels of homocysteine in the blood, and

• inflammation.

If these risk factors look familiar, it’s because they’re some of the same ones for heart disease. In fact, about 30% of people who experience a stroke will go on to have dementia.

What you can do to help prevent dementia

While there is no cure for dementia, studies point to the power of prevention. See your doctor if you are concerned about your memory, and try these tips to keep your brain healthy for the long haul.

• Maintain a healthy weight. This will help lower blood pressure, too.

• Eat a diet rich in brightly colored fruits and vegetables. These foods contain powerful antioxidants thought to combat the effects of aging. The spice, turmeric, might also help prevent dementia, so be sure to enjoy your curries.

• Get your B vitamins and omega 3s. Eat plenty of leafy green vegetables, bell peppers, shrimp, scallops, and cold water fish to boost the levels of these nutrients in your diet.

• Have an active social life. People who are more involved in their community are less likely to develop dementia.

• Get your daily exercise. Physical activity comes with many benefits, including weight loss, protection from dementia, lower blood pressure, and better mood. No amount is too little. Work your way up over time to at least 30 minutes on most days of the week.

• Keep your brain busy. Learn a new instrument, do crossword puzzles, play a game of hearts; whatever you can do to exercise your mind will help keep those neurons firing.

(Am J Clin Nutr 2011;doi:10.3945/ajcn.110.006320)

SOURCE: Health Notes newswire

Overprescribing the Healthy Elderly

As far as I know my mother was not prescribed statins during the last - highly drugged and controlled - years of her life.  She was over prescribed unnecessary psychiatric drugs.  None of the prescribed drugs were relevant to her closed head injury.  She was never referred to a neurologist in spite of my many requests, and she never received speech therapy for the expressive aphasia that kept her even more imprisoned.  My brother, a salesman for MetLife, ignored my requests for proper care  and later claimed I refused to collaborate on my mother's care.

Bentley Care Center threatened my brother if my mother was taken off the half dozen+ drugs, telling him she would be forced to move.  And most likely Medicare picked up the high priced tab for these drugs, a fraud in itself.

Elders aren't the only people who are over prescribed drugs by people who are not paying attention to the risks and hazards over time.  Health Forensics helps prevent this.

Why Funding Research and Drug Safety is Paramount

By Laura Newman | Jun 30, 2011 

My frail, 92-year-old mother was prescribed 80 mgs of the cholesterol-lowering drug, or statin, simvastatin for years. She fell four times in the last four years of her life: the last fall was the least forgiving. Doctors diagnosed her with rhabdomyolysis, a life-threatening condition, and acute kidney failure; she was dead within 8 weeks.

Source: Laura Newman

The MedlinePlus encyclopedia defines rhabdomyolysis as "the breakdown of muscle fibers and release of their contents (myoglobin) into the bloodstream." In severe case, "the myoglobin breaks down into potentially harmful compounds, blocking the kidneys, causing damage such as acute tubular necrosis or kidney failure. Dead muscle tissue may be caused by any condition that results in damage to skeletal muscle, especially trauma."

The FDA Safety Alert states that symptoms to watch for are: "muscle pain, tenderness or weakness, dark or red-colored urine, and unexplained fatigue" and should be brought to the attention of a health professional. Further, it advises doctors to inform patients taking that dose that they are at risk for rhabdomyolysis.

Rhabdomyolysis is a medical emergency. It is not uncommon after crush injuries, falls, and athletic feats. FDA’s safety warning that 80 mg simvastatin is linked to myopathy, issued on June 8, 2011, struck a chord in me because the 80 mg dose of simvastatin was the same given my mother.

An article in the Nov. 13, 2010 Lancet sounded an alarm that high-dose simvastatin could be hazardous. In a blinded randomized trial of more than 12,000 survivors of acute myocardial infarction, investigators found two (0.03%) cases of myopathy in patients taking 20 mg simvastatin daily, compared with 53 (0.9%) cases in the 80 mg group.

This finding could not be ignored. FDA pressed forward in further analyses. Even as my mother was in crisis, doctors told me that they were astounded that such a high-dose statin was given to a low-risk, frail, elderly women. By low-risk, she had no history of cardiovascular disease and she met the widely used and time-testedFramingham Risk Factor criteria. She did not smoke, had low-level, well-controlled hypertension, but a high cholesterol. I sensed deterioration months before she was diagnosed with rhabdomyolysis. Before she developed life-threatening rhabdomyolysis, she walked everywhere.

The Author and her mother in Canadian Rockies celebrating her 90th birthday. Source: Laura Newman

She called me, saying: "All of a sudden I feel exhausted, like my legs won’t support me, and I keep stopping and sitting down. I just don’t think I can do it anymore." Who knew whether it was normal aging? Her doctor did not think much of these changes.

FDA’s Simvastatin 80 mg Warning

FDA’s Drug Safety Communication: New Restrictions, Contraindications, and Dose Limitations for Simvastatin to reduce the risk of muscle injury state:

- Simvastatin 80 mg should not be started in new patients, including patients already taking lower doses of the drugs.

- Patients taking simvastatin 80 mg have an increased risk of myopathy compared to patients taking lower doses of this drug or other drugs in the same class.

- Muscle problems typically occur in the first year of use.

FDA is taking a major step to improve the public’s health. Whether it is far enough is debatable.

The consumer health advocacy group, Public Citizen considers 80 mg simvastatin unsafe and wants it off the market to protect the public. On its Worst Pills, Best Pillswebsite (subscribers only), it presses for a recall of 80 mg dose and urges consumers, no matter how long they have been on it, to ask their doctor for an alternative that is weaker.

According to FDA’s Safety Communication, approximately 2.1 million patients in the US were prescribed a product containing 80 mg simvastatin in 2010.

Prescribing Simvastin in the Elderly

Rodney Hayward, professor of public health and internal medicine at the University of Michigan, told me that sometimes, fatigue and muscle weakness are attributed to aging, when the culprit might be excess dosing. He said: "Unfortunately, people don’t realize that an excessive dose might be causing loss of appetite, muscle problems, and not eating enough. The most common adverse event with the high-dose statins are the myopathies, pain in the muscles." And if the old are not doing well, the sensible thing is to taper down."

Also, of critical importance, "as people age, the risks and benefits of people being on medicine change," said Hayward. "Processing through the kidneys especially is increasingly less effective. You want to be aware of how many medications, and how many doses people are on, and reconcile that with the amount of benefit and risk."

I thought that my mother had an eating disorder. She ate very little; it was all low fat, low cholesterol, and low salt. She ate like that for decades. She was 5’ 1" and weighed about 105 pounds. Her refrigerator was pretty empty.

Rita Redberg, MD, director of women’s cardiovascular services, the University of California San Francisco, points out that many trials of hyperlipidemia have not included enough women to determine gender-specific benefits and harms. Therefore, meta-analyses and systematic reviews become imperative. But particularly glaring is the reality that most studies have never demonstrated a survival benefit for statins at all for low-risk women like my mother, yet some doctors go so far as to put them on high-dose statins.

So one could argue that the benefit-risk ratio shifts towards harm in such women, particularly when they are given high-dose statins. Both Redberg and Hayward said that they know of no studies showing that low-risk people taken off statins are at increased risk for cardiac events. Hayward, Redberg, and many other physicians argue that doctors should be far more cautious in prescribing medications for the elderly.

"High-dose statins should almost never be used in the elderly," said Hayward. "In fact," he added: "I almost always use low doses of statins in people over 75 unless they have known heart disease, since most of the benefit of statins is achieved with low doses and there are good reasons to be concerned about the safety and tolerance of higher doses of statins in the elderly." People over age 75 are under-represented in clinical trials, leaving physicians in the dark as to safety.

Moreover, said Hayward: "With stepped-up dosing, the risk for harm escalates disproportionally. Most of the benefit from the simvastatin is in the initial dose. "

Factors in Overtreatment

Another issue of concern is whether overtreatment with high-dose statins has become widespread because of how heavy marketing, according to Hayward. Marketing of some statins promised achieving very low levels of low-density lipoprotein (LDL) cholesterol (a.k.a. "bad cholesterol"). It proved a valuable selling point. Setting targets this low may be inappropriate for the elderly, according to numerous pharmacoepidemiologists.

Also adding to the problem of overmedication are pay for performance (P4P) programs, which set specific targets in cholesterol-lowering to payment. Target setting is controversial because they may be too low for many individuals, yet they are widely used for assessing quality of care. One notable exception that may actually help keep the healthy elderly is that in HEDIS performance measures, people over age 75 are excluded from lipid-lowering targets.

Differences in the Elderly, in Women

Arguments pressing for treating the elderly differently have been commonplace for decades because the elderly have been under-represented in clinical trials; hence, guidance on practice are not science based (Zulman, Sussman, Chen, Cigalle et al., 2010; McMurd, Witham, Gillespie, 2005; Scott and Guyatt, ).

We are really in new terrain now, with an aging boom and more pills available for any symptom than could ever have been fathomed America’s shifting demographics in the United States, as evidenced by the most recent US Census Bureau report (Table left). The number of people in the oldest age group, namely age 85 and over, is rising, projected to grow from 5.8 million in 2010, to 8.7 million in 2030, and 19 million by 2050, according to the US Census Bureau. Not only have people age 75 and over been largely excluded from clinical trials, subgroup analyses in the aged have barely begun.

These should be compelling reasons for FDA, the Centers for Medicare and Medicaid Services, and Congress to back drug safety initiatives in the elderly. Many health researchers are also urging further study of potentially inappropriate medications (called PIMs) in elderly patients. Archives of Internal Medicine highlighted the problem in its June 13, 2011 issue, and there is a growing literature on it.

A recent study of elderly ICU survivors found that 85 percent were discharged with 1 or more potentially inappropriate medicines, with more than 50 percent in that group discharged with medications deemed more harmful than beneficial (Morandi et al, 2011). The authors press for more attention to appropriateness reviews, with the rationale for starting each therapy in the ICU, and discussion of when it can be stopped.

Brian Strom, MD, professor of public health and pharmacology, University of Pennsylvania, describes the issues this way: "The problem is Congress and our research agencies. They fund so little work on the pharmacology of the aged and other demographic subgroups, and their risk of drug interactions. And, there is phenomenally small, and shrinking by 60% (down to $5.1 million/year), amount of money being spent supporting the Centers for Education and Research and Therapeutics, who are charged with doing studies that industry would not fund, and with changing prescribing to be more rational."

Caregiver Remorse

The entire experience of trying to find quality care for my mother was made especially difficult because of the dearth of good clinical practice guidelines and science guiding chronic care for the elderly. I think it is way too much to ask family and caregivers to take this on. Now both my parents are dead. I see friends and family struggle under impossible odds, yet physicians who care for the elderly have little science to guide them.

This is where Congress, the Centers for Medicare and Medicaid Services, and the FDA must step up, expand funding, and beef up post-marketing drug surveillance. FDA has a treasure trove of safety data that has been deemed proprietary, some of it preferentially published, that could improve the public’s health. "No one has the right to respect this data except the FDA,"said Hayward. "Most of the trials data is industry-supported and the industry can hide safety data," he said, "but with public pressure, ineffectiveness and harm may be detected."

Without well-funded research and analyses of subgroups of the aged (age 85-100), and postmarketing surveillance, the US is operating in too much darkness and uncertainty for the public’s health. Many generations of Americans will continue to suffer.

The aged take disproportionally more drugs than every group, and as a result are more at risk for drug-drug interactions. It will take a significant commitment from the federal government to marshall science and surveillance of drugs in this population.

References:

Rhabdomyolysis. Accessed on June 27, 2011.

FDA Simvastatin 80 mg drug safety. Accessed on June 27, 2011.

Armitage et al. (2010) Intensive lowering of LDL cholesterol with 80 mg versus 20 mg simvastatin daily in 12,064 survivors of myocardial infarction: a double-blind randomised trial, Lancet: 376(9753):1658-69. Epub 2010 Nov 8.

Morandi et al. Inappropriate Medications in Elderly ICU Survivors: Where to Intervene? Arch Intern Med.2011; 171: 1032-1034.

Risk Assessment Tool for Estimating Your 10-year Risk of Having a Heart Attack Ten-Year Cardiovascular Disease Risk Calculator. Third report from the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol. Downloaded on June 27, 2011.

Walsh JME, Pignone M. Drug treatment of hyperlipidemia in women. JAMA 2004; 291(18):2243-2252. Abstract

Scott IA, Guyatt GH. Cautionary tales in the interpretation of clinical studies involving older persons.Arch Intern Med. 2010 Jun 14;170(11):927.

Jerry H. Gurwitz; Robert J. Goldberg. Age-Based Exclusions From Cardiovascular Clinical Trials: Implications for Elderly Individuals (and for All of Us): Comment on "The Persistent Exclusion of Older Patients From Ongoing Clinical Trials Regarding Heart Failure" Arch Intern Med, Mar 2011; 171: 557 - 558. doi:10.1001/archinternmed.2011.33

Cho S, Lau SWJ, ; Tandon,V; Kumi K, Pfuma A, Abernethy DR Geriatric Drug Evaluation. Where Are We Now and Where Should We Be in the Future? Arch Intern Med. 2011;171(10):937-940. doi:10.1001/archinternmed.2011.152

Vincent, Grayson K. and Victoria A. Velkoff, 2010, THE NEXT FOUR DECADES, The Older Population in the United States: 2010 to 2050, Current Population Reports, P25-1138, U.S. Census Bureau, Washington, DC.

Hamilton H, Gallagher P, Ryan C, Byrne S, O'Mahony D. Potentially Inappropriate Medications Defined by STOPP Criteria and the Risk of Adverse Drug Events in Older Hospitalized Patients. Arch Intern Med. 2011 Jun 13;171(11):1013-9

Schnipper J. Medication Safety: Are We There Yet?: Comment on "Potentially Inappropriate Medications Defined by STOPP Criteria and the Risk of Adverse Drug Events in Older Hospitalized Patients". Arch Int Med 2011 Jun 13;171(11):1019 

About the Author: Laura Newman writes about medicine, health policy, and clinical outcomes research. She has a long-term interest in healthcare reform and what matters to patients. She has written news in health and medicine in peer-review journals, on the web, and for newsletters. Laura blogs at Patient POV, is active on twitter at  @lauranewmanny, and she is especially interested in integrating patients into health reform efforts. The views expressed are those of the author and are not necessarily those of Scientific American.  SOURCE

Selections from Natural Health News 

Too many Drugs, Too High Doses: Too Much for Elders

Dec 23, 2009

Old heart patients 'over-drugged' Elderly patients are being treated too aggressively for high blood pressure, researchers claim. They say the "oldest olds", meaning patients aged 80 plus, are being given too many drugs and in too large ...

http://naturalhealthnews.blogspot.com/

Natural Health News: The Case of a Sequestered Mind

Dec 18, 2010

The drug interaction profile will tell you that many of these are NOT supposed to be given together, and the research tells you that Zyprexa is not for Elders, especially women. My younger brother, a MetLife salesman, ...

http://naturalhealthnews.blogspot.com/

Natural Health News: Is CODEX for Killing the Elderly?

Jul 13, 2005

Remember that AARP supported the Bush drug plan for Elders. This plan is about the biggest corporate welfare plan to come along in years; it surely doesn't do much for health. I'm not sure why Bill Sardi no longer is the ...

http://naturalhealthnews.blogspot.com/

Natural Health News: Bone Health and AntiAcid Drugs

May 26, 2010

Please note that these drugs are not good for babies and young children which is a common practice today. Elders may have more problems with the drugs because of delayed metabolism times. In the May 10 Archives of ...

Natural Health News: Adverse Drug Events in Seniors

Jun 14, 2011

A new set of criteria for identifying potentially hazardous medications in elderly patients accurately predicted serious adverse drug events, a prospective study found. from Natural Health News ...

http://naturalhealthnews.blogspot.com/

Natural Health News: Drugs Slow Elders' Recovery

Mar 30, 2010

Sedating Drugs May Slow Elders' Recovery By Ed Susman, Contributing Writer, MedPage Today, January 15, 2010. Elderly patients sedated with morphine or haloperidol (Haldol) were less likely to to be discharged to their ...

http://naturalhealthnews.blogspot.com/

Natural Health News: Call to end exclusion of elderly from drug trials

Feb 02, 2010

Zyprexa is questionable for the elderly, especially for use in elderly women, and it can precipitate diabetes. The case in point is that regardless of the number of drugs prescribed, and failure of the center to evaluate...

http://naturalhealthnews.blogspot.com/

Anti-convulsant Drugs Increase Suicide Risk in Elders

May 10, 2010

This article points out problems with anticonvulsant drugs. It is important to be because the gabapentin mentioned in the article showed suicide was increased with gabapentin and the increased risk was greater in Elders. ...

Sunscreen Hazards

BP3 shows toxic results in animal studies, human impact cannot be far removed.

"Dietary studies that affected body weight gain—showed alterations in liver, kidney, and reproductive organs in rats and mice administered BP-3 dermally and orally." Complete article

More information about the endocrine and other environmental impact of sunscreen is here and here.

Natural Sun Care

Sunscreen fails to protect from skin cancers and melanoma.

• Pass through the placenta, altering crucial male/female sex differentiation.

• 97% of Americans have sunscreen chemicals in their blood.

• Pass into mother's milk, causing hormone disruption. (many of the chemicals are fluoride based endocrine disruptors.

• Cause men's breasts to grow.

• Block vitamin D synthesis epidemic of vitamin D deficiency disease.

http://www.leaflady.org/10_ingredients.htm
12 ingredients to avoid often found in sunscreen and other personal care products:
Coal Tar Colors: FD&C Blue 1, Green 3, Yellow 5&6; D&C Red 33 Diethanolamine (DEA, TEA)
Quaternium 15 (Formaldehyde)
Glycol Ethers; Phenylenediamine (PPD)
Methyl, Propyl, Butyl and Ethyl Parabens
Petrolatum
Sodium Lauryl / Laureth Sulfate (SLS)
Toluene; Mercury and Lead
Fragrance (contains Phthalates)
Antibacterials (ex: triclosan)

Selections from Natural Health News

Natural Health News: Sunscreen Allergies

May 15, 2011

In 2008 Natural Health News reported on sunscreen as unsafe and ineffective. Earlier than this, along with an expert on the subject, we tackled mis-information being promoted by Dr Oz's "Real Age". ...

Natural Health News: Sunscreen Safety at Issue

May 23, 2011

It's that time of year when sunscreen advertisements become ubiquitous on television—cute kids prancing on the beach after their mothers conscientiously apply multiple coats of white lotion in an effort, the companies ...

Natural Health News: 84% of Sunscreens Unsafe or Ineffective

Jul 05, 2008

Only 16% of sunscreens on the market are both safe and effective, according to a new analysis by the Environmental Working Group, an advocacy and research organization. Of 783 products analyzed, only 125 blocked both UVA ...

Natural Health News: Suncreen May be Hiding the Facts

May 24, 2010

It is very important to take the time to read labels when purchasing sun screen. You might also want to increase use of vitamin B1 and make a vitamin C solution for a spray bottle. Both help act as sunscreens. ...

Paleo Diet in Words and Pictures - For Your Health!

Learn more about the Paleo Diet.

Heartburn, GERD, and Acid Blocking Drugs

Today I received an informative newsletter from a colleague.  One item he included looks at the issue of gastric problems with antiacid drugs.  Here the information looks at the link between these drugs and the development of polyps as well as paralysis of the stomach and gut dysmotility.

Dr A Breck McKay, in a letter to the British Medical Journal, said " long term use of PPIs cause gastroparesis, delayed total gut dysmotility and bloating" Patients suffer  acute, explosive, exacerbation of their gastritis and reflux, on attempted cessation of the PPIs. While the PPI drugs block acid production, these drugs actually stimulate hormones like gastrin, cholecystokinin, and glucagon which in turn stimulate growth of acid producing cells to massively increase and thus, are able to produce large quantities of acid, suddenly, when inhibition from the acid blocker PPI drug stops.

For the rest of this article go here.

PPIs and related drugs cause many problems and they are not quite as safe as you may have been led to believe.

Selections from Natural Health News

Natural Health News: Bone Health and AntiAcid Drugs

May 26, 2010

While you now just are learning about the problems with acid reflux drugs you might wish to know that this is no real surprise. The drugs shutdown acid production in the stomach that impairs protein metabolism because ...

Natural Health News: Resolve Acid Reflux with Care, Naturally

Jan 19, 2009

WASHINGTON (Reuters) – Two nonsurgical procedures relieve many symptoms of acid reflux disease including heartburn in people who are not helped by the medications typically used to treat it, U.S. researchers said on ...

Natural Health News: Wonderful Catmint

Mar 28, 2011

After all, before all the GE pharmaceuticals, herbs were the basis of the National Formulary, and toxic acid reflux drugs were not given out with glad hands in deference to a few grains of acidophilus. Add Your Knowledge ...

Natural Health News: Anti-Acid Drugs, H. Pylori, Vitamin C

Jun 23, 2009

While we often see an increase in H. pylori with the increases in anti-biotics and anti-fungal drug use, we often don't see vitamins in a good light. Of course anti-acid drugs depress immune function in the stomach because they suppress hydrochloric acid. ... One is to first look to determine if the person has too low HCl as a cause of their reflux problem or properly evaluate for food allergy. Take more vitamin C daily and also consider using BioPrin. ...

Natural Health News: Natural Health Tip - PPI

May 13, 2009

For most people who would like a natural replacement for anti-acid drugs start first by getting a true evaluation of the hydrochloric acid level in your stomach. If it is low then consider using Betaine HCl supplements. ...

Chantix Risks Once Again

Since 2007 Natural Health News has been covering Chantix (Champix).  Today a new report show continuing risk with the drug.

FDA Warns of MI, PAD Risk With Chantix

By Peggy Peck, Executive Editor, MedPage Today
Published: June 16, 2011

WASHINGTON -- The FDA warned today that smokers with a history of heart attack or stroke who use the smoking cessation drug varenicline (Chantix) may increase their risk of a second heart attack or new onset peripheral vascular disease.
The agency said an additional warning will be added to the drug's label and prescribing information describing a small, but measurable increase in the risk of cardiovascular events including nonfatal myocardial infarction, angina, and need for coronary revascularization.
Additionally, the label will warn that use of varenicline may increase the risk for a "new diagnosis of peripheral vascular disease or admission for a procedure for the treatment of peripheral vascular disease" among persons with a history of cardiovascular disease.
In its announcement, the FDA noted that smoking significantly increases the risk of cardiovascular events, so it advised physicians and patients to weigh the known benefits of varenicline treatment "against its potential risks when deciding to use the drug in smokers with cardiovascular disease."
The FDA decided to add the warnings after it reviewed data from a randomized, double-blind, placebo-controlled study of 700 smokers with a history of cardiovascular disease who were treated with varenicline or placebo.
The FDA said it was "continuing to evaluate the cardiovascular safety of Chantix" and had ordered the drug's maker to conduct a meta-analysis of data from all varenicline studies as part of an ongoing review of the drug's cardiovascular safety.
Concerns about cardiovascular safety come on top of previous reports of increased risk of suicidal ideation association with varenicline, which is marketed by Pfizer.

Selections from Natural Health News

Natural Health News: CHANTIX Gets High Danger Rating

Feb 01, 2011

The latest January 2011 QuarterWatch (analyzing FDA's MedWatch adverse effect reports for Quarter 2 of 2010) found that despite prominent label warnings, the stop-smoking drug varenicline (CHANTIX) continues to pose ...

Natural Health News: Chantix Still A Danger to Health

Dec 17, 2010

A reader was looking for natural alternatives to Chantix/Champix, so I thought I'd provide some information based on methods I've suggested to people over the years that have been very helpful. I generally suggest that ...

Natural Health News: More on the dangers of Chantix

Feb 02, 2008

"We've become increasingly concerned as we've seen there are a number of compelling cases that truly look as if they are the result of exposure to the drug," Bob Rappaport, a director in FDA's unit that oversees Chantix, ...

Natural Health News: The Chantix File Expands

Jun 18, 2008

Yes, Chantix is associated with a large number of suicides, but what is more devastating is the recruiting of our already abused soldiers to test the drug, and just for thirty pieces of almost worthless paper. ...