Chantix Risk Rises Again

Natural Health News has been covering Chantix since 2006.  There are at least a dozen articles here that speak to the dangers of this drug.

Now it is announced that there is a risk of PAD and other cardiovascular diseases caused by the drug, and the study shows about 62,000 people are affected.

The report follows an FDA announcement last month that prescribing information for varenicline will be revised to include a warning about an increased risk of second heart attack and peripheral artery disease in people with a history of cardiovascular disease.  SOURCE

If you are interested in stopping smoking using natural options please contact us or Health Forensics. 

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. ...

CHANTIX Gets High Danger Rating

CHANTIX Linked to Highest Number of Reports--Hostility-Aggression, Psychosis
Psychiatric News

Overall in the 2nd quarter of 2010, the FDA received 33,068 domestic reports of serious injury, disability or death associated with drug therapy--an increase of 12% from the same quarter one year ago.

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 serious life-threatening risks. 

A year after FDA required a prominent boxed warning, a mandatory Medication Guide for every patient and declining use, CHANTIX continued to account for the largest numbers of reported serious psychiatric side effects that pose serious risks of harm. The case reports involving CHANTIX, primarily of hostility-aggression, depression and psychosis, pose serious risks--not only to those who use it--but also to others who may be victimized by consumers of the drug who become psychotic or aggressive.

For this reason, the Federal Aviation Administration has banned varenicline for pilots and air traffic controllers; the Department of Transportation has limited its use among truck drivers; and the Department of Defense has banned it for use by some military personnel, including pilots and missile crews.

The evidence shows that irresponsible physicians prescribe dangerous drugs under the influence of the drugs' manufacturers?  Read more

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 if you are a . ...

Natural Health News: Top 10 Drugs: Violence and more Fluoride

Jan 12, 2011

1) Varenicline (Chantix) The anti-smoking medication Chantix affects the nicotinic acetylcholine receptor, which helps reduce craving for smoking. Unfortunately, it's 18 times more likely to be linked with violence compared to other ...

Natural Health News: More on the dangers of Chantix

Feb 02, 2008

The Food and Drug Administration (FDA) said that after an analysis of cases of depression, suicidal thoughts and other unusual behavior in patients on the medication, the evidence appears stronger of an association with Chantix. ...

The Chantix File Expands

Jun 18, 2008

“His on-to-Wall-Street approach succeeded in rushing Chantix, Pfizer's stop smoking drug, varenicline, to market but a string of 2006 suicides and the violent death of Dallas musician Carter Albrecht leave many asking if that was such a ...

Chantix Still A Danger to Health

Several years ago I started alerting people to problems with Chantix, mainly because of the suicide risk associated with the drug.

It seems as if the problem with the drug continues to be newsworthy -
Quitting Smoking Can Be Dangerous to Your Health

Selections from Natural Health News 

Natural Ways to Help Stop Smoking

Apr 30, 2009

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 if you are a ...

Drug Death, the FDA, and You

Dec 16, 2010

The worst offender with the strongest association to uncontrollable, murderous violence--within days of ingesting the drug--is the smoking cessation drug, Chantix (varenicline), which increases dopamine: it ranks 18.0 in the ...

Natural Health News: More on the dangers of Chantix

Feb 02, 2008

The Food and Drug Administration (FDA) said that after an analysis of cases of depression, suicidal thoughts and other unusual behavior in patients on the medication, the evidence appears stronger of an association with Chantix. ...

The Chantix File Expands

Jun 18, 2008

“His on-to-Wall-Street approach succeeded in rushing Chantix, Pfizer's stop smoking drug, varenicline, to market but a string of 2006 suicides and the violent death of Dallas musician Carter Albrecht leave many asking if that was such a

More on problems with smoking and stop smoking drug Chantix

May 22, 2008

A US Food and Drug Administration spokeswoman said the agency was focusing on likely links between Chantix and neuropsychiatric side effects. This year, the FDA and Pfizer, which manufactures the drug, updated warnings on Chantix's ...

Natural Ways to Help Stop Smoking

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 if you are a smoker you add vitamin C to your daily routine. Each cigarette you smoke causes you to lose 100 mg to 500 mg. Vitamin C does help protect your lungs and your health in general.

I also suggest vitamin A (a combined A/beta-carotene product because many cannot convert beta-c to A) because it protects the mining of your respiratory system.

And of course vitamin E (natural only, not soy based or the artificial type, dl tocopherol acetate) because it helps oxygen cross the from the lungs to blood.

Start with a switch to no-chemicals-added tobacco. Many reservation tobacco stores offer these cigarettes under tribal brands. American Spirit is a commercial and pricey brand sold in most stores.

Smokers who use menthol cigarettes do seem to have a harder time quitting according to studies I have read.

We have offered a variety of products:

Homeopathic tablets or drops

Herbal liquid drops and Herbal capsules

Light-activated drops and soaks to help remove the nicotine from the body

If you're interested in learning more about any of the options we have available, just get in touch with us for more information.

Read More...

Beware, genetically engineered and newer biological drugs

There is a rather well publicized issue surrounding multiple myeloma and the possibility of symptomatic treatment from a drug in this class that is approved for MS and Crohn's Disease. One of the serious side effects of the drug is that it can cause multiple myeloma and a very severe bacterial invasion of brain tissue that can be fatal. The drug is listed on the FDA's drug advisory information pages. These are reasons why the drug is so tightly controlled. Another may be that the effects of the drug really isn't known because no long term studies are completed before FDA approval and marketing.

Humira and other arthritis drugs have been worrisome for years, the risk of cancer has been raised, yet they are still plentifully prescribed.

Some forms of arthritis are well known to be associated with food allergy but this concept is absent or fleeting over (knee-jerk) consideration for promoting the drug.

Some cases of Chrohn's may be helped with more nutritional and natural approaches to revitlize the gut lining and function. Now this is a novel idea in MSM but its one I've seen work time and time again.

MS and multiply myeloma can be helped with more natural approaches too.

There just needs to be a better approach to health care.

Safety a problem for new generation drugs, tooBy LINDSEY TANNER, AP Medical Writer

He said the results simply show that doctors and patients should be aware that the drugs have many potential side effects that may not be listed on the label.

CHICAGO – Nearly a fourth of widely used new-generation biological drugs for several common diseases produce serious side effects that lead to safety warnings soon after they go on the market, the first major study of its kind found.

Included in the report released Tuesday were the arthritis drugs Humira and Remicade, cancer drugs Rituxan and Erbitux, and the heart failure drug Natrecor. All wound up being flagged for safety.

That might surprise some doctors who may have thought that these new treatments might be safer than traditional chemical-based medicines.

Researchers found that most of the warnings came within five years after these biologicals won government approval in the United States and Europe between 1995 and 2007.

Many traditional medicines wind up with safety warnings too after they go on the market. But experts said there were no similar studies of older medicines that made it possible to compare safety issues between the two groups of drugs.

The new study, by Dutch researchers, is the first comprehensive examination of these newer medicines, a driving part of the biotech revolution.

The drugs are known as biologicals because they're made from living material and they typically affect the body's disease-fighting immune system. Many relieve severe symptoms by suppressing that system.
It's that same mechanism that can result in side effects often not seen with traditional chemical-based medicines, said Dr. Charles Bennett, a Northwestern University drug safety expert. These can include brain and fungal infections and cancer.

Many are genetically engineered and Bennett said that because they typically resemble naturally occurring proteins, many doctors have assumed they were safer than traditional chemical-based medicines. But he said the study shows that's not necessarily true.

"They have an important role," Bennett said. "They're really the next generation of pharmaceuticals."

He said the results simply show that doctors and patients should be aware that the drugs have many potential side effects that may not be listed on the label.

Among the drugs under examination are Genentech Inc.'s psoriasis drug Raptiva, which just last week the Food and Drug Administration warned may contribute to a life-threatening brain illness and infections; and Exubera, an inhaled insulin product, linked with lung cancer risks. Exubera was approved by the FDA in 2006 but Pfizer Inc. stopped selling it last year.

The study appears in Wednesday's Journal of the American Medical Association.

It involved 136 biologics approved in the United States and 105 in the European Union between January 1995 and June 2007. A total of 41, or nearly 24 percent, got safety warnings issued through June 2008.

The results are a concern, and they underscore the need for closer scrutiny of drugs after their approval, said lead author Thijs Giezen of the University of Utrecht.

But he said the study also is reassuring because most problems showed up relatively soon after the drugs became available, which minimized the potential for widespread harm.

"If most issues are discovered within the first few years, then the system is working," Giezen said.

Bennett says it's unreasonable to think that the studied drugs' safety issues should have been discovered before they were marketed. That's because drug approval is based on relatively small studies with patients who generally are healthier than those in the general population. It often takes real-world experience for side effects to appear, he said.

Many biological drugs have advantages over conventional medicine, but the study shows their risks need to also be considered, said Thomas Moore of the Institute for Safe Medication Practices.

For example, non-steroid arthritis medicines including ibuprofen can reduce pain by decreasing inflammation, but they can cause stomach bleeding.

Biologic rheumatoid arthritis medicines Remicade, Enbrel and Humira are designed to ease painful joints by keeping the body's immune system from attacking itself, the underlying problem in the disease. But they are much more expensive and have been linked with higher risks for potentially fatal infections. Also, the FDA is investigating possible cancer risks.

"My message to patients is that these biological products often can treat very difficult to treat diseases but may have very substantial risks and that you need to take extra care to educate yourself as to what those risks might be," Moore said.

And in another report on this timely topic -

Reports of serious drug reactions hit recordBy RICARDO ALONSO-ZALDIVAR, Associated Press Writer

WASHINGTON – The number of serious drug reactions and deaths reported to the government shot up in the first three months of this year to set a new record, a health industry watchdog group said Wednesday.

The Food and Drug Administration received nearly 21,000 reports of serious drug reactions, including more than 4,800 deaths, said an analysis of federal data by the Institute for Safe Medication Practices.

Two drugs accounted for a large share of the latest reports. One was the blood thinner heparin. Most of the drug's problems were prompted by tainted heparin imported from China. The other was Chantix, a new kind of anti-smoking drug from Pfizer.

Chantix, which had the most reports of any medication, works directly in a smoker's brain to ease withdrawal symptoms. It also blocks the pleasurable effects of nicotine if the patient is tempted to light up again. Earlier this year, the FDA warned that Chantix may be linked to psychiatric problems, including suicidal behavior and vivid dreams. Pfizer said Wednesday it stands by Chantix, and that the volume of reports might be linked to publicity about the side effects.

"The FDA is aware of the increasing number of reports, and we take them seriously," said spokesman Christopher DiFrancesco. But officials are not sure whether reports are up because problems are getting worse, or simply due to greater awareness about drug safety issues.

The watchdog group that prepared the analysis has served hospitals and pharmacists for years as a clearinghouse for information on medication errors. Known as ISMP, the organization is now trying to reach consumers with regular reports on drug safety trends.

"We believe that one of the most important tools to promote is to monitor trends on a regular basis," said Thomas J. Moore, a senior scientist with ISMP. "Knowing which drugs are causing injuries and how many people are being hurt is the raw material we need to fashion sound measures to promote patient safety."

The FDA defines serious drug reactions as ones that cause hospitalization, require medical intervention, or place a life in jeopardy. The agency's monitoring system relies on voluntary reports from doctors and is only believed to capture a fraction of overall problems.

The 20,745 cases reported from January through March was 38 percent higher than the average for the previous four calendar quarters, and the highest for any quarter, the report said.

The number of deaths, 4,824, was a nearly threefold increase from the last calendar quarter of 2007. The FDA said heparin was largely to blame.

Previous ISMP research has shown that reports of serious drug safety problems had increased markedly since the late 1990s.

The FDA case reports provide a signal of possible problems with a drug, but a cause-and-effect connection can only be established through painstaking investigation. If the FDA were a police agency, the reports would indicate "probable cause," but not necessarily "guilt beyond a reasonable doubt."

The ISMP study found that heparin accounted for 779 reports of serious problems, including 102 deaths. The FDA, using data that covers a longer time period, has reported 238 deaths possibly linked to heparin.

Heparin "illustrates an example of a significant drug safety problem that was promptly and effectively resolved by the drug manufacturers and the FDA once the issue was detected and understood," the report said.

Not so with Chantix, it concluded.

The FDA should forcefully warn patients taking Chantix that they may have blackouts that could lead to accidents, the report said. Current warnings say patients may be too impaired to drive or operate heavy machinery, but such language is standard for many medications. The government has banned the drug for pilots.

The report found 15 cases of Chantix patients who appeared to have been involved in traffic accidents, and 52 additional cases involving blackouts or loss of consciousness. The FDA said it taking a second look at the Chantix warnings.

The agency received 1,001 reports of serious injuries linked to Chantix, more than for the 10 best-selling brand name drugs combined.

Chantix "continued to provide a striking signal of safety issues that require investigation and action," the report said. The authors acknowledged Pfizer's concern that publicity may be driving up the number of reports, but concluded there's enough evidence to warrant stronger FDA action.

Pfizer said the total sum of its Chantix data, including results from clinical trials, show the drug's benefits clearly outweigh its risks.

"We stand by the efficacy and safety profile of Chantix," the company said in a statement. "There are few things that provide greater health benefits than quitting smoking. Pfizer is committed to reducing the prevalence of smoking globally. As part of that mission, we want to increase peoples' understanding of the dangers of smoking and the benefits of quitting."

But then again we've mentioned Chantix in several other posts herein.
And if you've queries regarding more natural ways to approach stopping smoking, contact us.