Drug Side Effects Report Cards - FDA

U.S. proposes 'report cards' for drugs

Last Updated: Tuesday, January 30, 2007 | 7:03 PM ET

Drug "report cards" may list any unexpected side-effects that become known within 18 months of a drug's approval, the U.S. Food and Drug Administration said Tuesday in response to criticism of the agency's drug safety oversight.

In September 2006, a panel of experts at the U.S. Institute of Medicine said the FDA needed to boost its staff, funding and power to track the safety of not only new medications, but also drugs already on the market.

The panel met after Merck & Co. pulled its anti-inflammatory drug Vioxx from the market in 2004, five years after it was approved. Long-term use of the drug was linked to an increased risk of heart attack and stroke.

The institute's report concluded that FDA officials downplayed concerns raised by safety reviewers after drugs were approved. The report also suggested the FDA did a poor job of managing scientific disagreements among staff.

In its response on Tuesday, the FDA said it was "making specific organizational and management changes to increase communications among FDA review staff and safety staff."

The response is not the final word, FDA Commissioner Dr. Andrew von Eschenbach said.

"It will be a continuous process of improvement. The initiatives we are announcing today are not the full story, nor are they the final chapter in that story," von Eschenbach told reporters in Washington.

The FDA's response includes plans to:

• Upgrade its electronic database for tracking potential side-effects.
• Create a new advisory panel on risk communication.
• Publish regular newsletters summarizing safety reviews of older drugs, including any emerging issues that do not include information the agency considers confidential.

The response came days before U.S. senators are to introduce legislation for drug safety changes.

Source: CBC.ca

Fat Rats No More

Source: Discover Top 100 Stories 2006

Diabetes Cure part 1

Diabetes Cure part 2

Diabetes Cure part 3

New Stop Smoking Drug Approval

Stop-smoking drug wins Health Canada approval

Champix boasts 22 per cent success rate, has no nicotine base

Last Updated: Thursday, January 25, 2007 | 3:54 PM ET

Health Canada has given the nod to the first smoking-cessation drug to hit the market in a decade.

Champix — which was discovered and developed by Pfizer — is one of two quit-smoking drugs that are not designed to replace the nicotine kick that cigarettes offer.

The drug works in two ways — by cutting the pleasure of smoking and reducing the withdrawal symptoms that frequently derail smokers' efforts to quit. If a person smokes while taking Champix, the drug can reduce the sense of satisfaction associated with smoking.

Champix latches on to the same receptors in the brain that nicotine binds to when inhaled in cigarette smoke. The action leads to the release of dopamine in the pleasure centres of the brain. Taking the drug blocks any inhaled nicotine from reinforcing that effect.

Most other stop-smoking drugs are nicotine-replacement therapies, either sold by prescription or over the counter in gum, patch, lozenge, nasal spray or inhaler form. The only other prescription drug sold to help people to quit smoking is Zyban. In the United States, Champix sold under the brand name Chantix.

Champix was approved for sale in Europe in 2006.

Several studies conducted in Europe on about 2,000 smokers showed that a year after initial treatment with Champix, a little more than one in five people stayed off cigarettes. Zyban's success rate is estimated at about 16 per cent. Only eight per cent of those who were given a placebo in the study had stopped smoking after a year.

Champix treatment includes 12 weeks of taking the drug as well as smoking-cessation counselling. Pfizer said the drug's possible side-effects include nausea, abnormal dreams, constipation, flatulence and vomiting.

According to Health Canada, more than 4.5 million Canadians — or about 18 per cent of the population age 15 years and older — smoke. More than 37,000 people die prematurely each year in Canada due to tobacco use and at least 800 non-smokers die every year from exposure to second-hand smoke.

Source: CBC.ca Jan. 25/07

It's Getting Hot in Here part 2

Source: Discover Top 100 2006

Depressed Bones

Antidepressants linked to bone fractures

LINDSEY TANNER

Associated Press

CHICAGO — The most popular pills for depression might substantially raise the risk for bone breaks in older people, a drawback that should be considered when the drugs are prescribed, Canadian researchers say.

People aged 50 and older who took antidepressants, including Zoloft, Prozac and other top-sellers, faced double the risk of broken bones during five years of follow-up, compared with those who didn't use the drugs, the study found.

Still, few of 5,008 people studied used the drugs and had fractures. While more rigorous research is needed to prove the link, the study provides the strongest evidence yet tying these drugs to fracture risks, said Dr. David Goltzman, an endocrinologist at McGill University in Montreal and one of the study authors. The study was part of ongoing osteoporosis research funded partly by the Canadian Institutes of Health Research and makers of osteoporosis drugs.

Antidepressants have been linked with low blood pressure and dizziness leading to falls, which can increase risks for broken bones, but the researchers said they found fracture risks independent of those factors.

Research in animals suggests that the pills might have a direct effect on bone cells, decreasing bone strength and size, Dr. Goltzman and colleagues said.

The results have important public health implications since millions of people worldwide use the drugs and because osteoporosis, a bone-thinning disease that can lead to broken bones, can be so debilitating for older adults, Dr. Goltzman said.

Still, the researchers said potential fracture risks should be balanced against the drugs' effectiveness at treating depression, which also can be debilitating.

“If patients need these drugs, they should not be advised against taking them because of the fracture risk. They should however be warned about the risks,” Dr. Goltzman said.

The study appears in Monday's Archives of Internal Medicine.

Some previous studies found similar results but did not adequately consider other factors, the researchers said.

Dr. Gregory Asnis, director of an anxiety and depression clinic at Montefiore Medical Center in New York, said depression itself has been linked with low bone density, and it's possible the disease rather than the drugs could explain the findings. He said more rigorous research is needed.

The drugs in question are called SSRIs or selective serotonin reuptake inhibitors. These are generally the favoured treatment for depression in many patients, the researchers said.

The study tracked 5,008 Canadians aged 50 and older for five years. They included 137 people who reported using SSRI antidepressants daily. In this smaller group, 18 people or 13.5 per cent had bone fractures during the follow-up, compared with 317 people with fractures or 6.5 per cent among the 4,871 who didn't take the pills.

Broken forearms, ankles, feet, hips and ribs were the most common fractures.

Amy Sousa, a spokeswoman for Prozac maker Eli Lilly and Co., said the drug's label lists osteoporosis as a potential but rare side effect. Still, she said the new study was too small to establish any proof that SSRIs might cause fractures.

Pfizer Inc., maker of Zoloft, issued a statement responding to the study and calling depression “a serious problem in the elderly that is under-diagnosed and under-treated.”

“SSRIs are an important option for the treatment of depression in this population. As the authors note, the risks must be balanced against the benefits gained by the treatment of depression,” Pfizer said


Source: The Globe and Mail.com

Recall on Nut Filling

Green Bean Cake being recalled due to undeclared sesame filling

Last Updated: Wednesday, January 24, 2007 | 5:39 AM ET

The Canadian Press

The Canadian Food Inspection Agency is warning people with allergies to sesame seeds not to consume some packages of Green Bean Cake.

The affected product contains a sesame filling which is not declared on the label.

The Green Bean Cake was imported from China by Wing On New Group Canada Inc., in Markham, Ont.

The product is sold in 240 gram packages bearing the UPC 6 927091 806011 and all codes are affected by this alert.

There is no brand name listed in English or in French. This product has been distributed in Ontario.

There has been one reported reaction associated with the consumption of this product.

Consumption of this product may cause a serious or life-threatening reaction in persons with allergies to sesame seeds.

The importer is voluntarily recalling the affected product. The CFIA is monitoring the effectiveness of the recall.

For more information, consumers and industry can call the CFIA at 1-800-442-2342 / TTY 1-800-465-7735 (8:00 a.m. to 8:00 p.m. ET, Monday to Friday).

Source: CBC.ca

It's Getting Hot in Here part1

Source:
Discover Magazine
Top 100 Stories
2006

Organic Supply and Demand

Source: Wired January 2007

Beware the Creamer

Source: Wired January 2007

Read the bottom left column ingredient than scan
the second one in the right column.

In the Weeds

Source: TIME A to Z Health Guide

20 minutes to Bliss

5 lbs of Fat

Possible is Anything

Source: Now defunct Sports Illustrated for Women,Sept 2002

Coke Isn't It

Doctors Warn Against "Cocaine" Energy Drink

It's called "Cocaine" but it doesn't contain the drug you think it does.

This is one of those 'energy drinks' that have become all the rage on store shelves, especially with the younger crowd.

It essentially delivers a jolt of high levels of caffeine, which gives drinkers a feeling of at least temporary energy and alertness.

But the fact that this particular drink is aimed at kids and has been given that name is upsetting a lot of people.

Cocaine was launched in September of last year and was supposed to be a competitor to Jolt Cola, Red Bull and other similar concoctions.

But with 280 miilgrams of caffeine in each can, it went far beyond the others.

Its creators originally wanted to call it Reboot. But they got lucky when they found the name was already taken. So they decided to try something else.

"We knew we would get noticed against a thousand other energy drinks," Hannah Kirby recalled last fall. "We knew kids would find it cool, but we also wanted to stress the idea that it's an energy drink, you don't need drugs."

And so Cocaine - the drink - was born.

But with a moniker like that, it was bound to upset parents.

Many stores in the U.S., including 7-11, have banned it.

It's technically not for sale in Canada, but you can order it over the Internet. Which is how CityNews got hold of it. And so can your kids.

And now many are asking is it dangerous for them?

It's not the danger that's the problem, believes Dr. Miriam Kaufman of the Hospital for Sick Children. It's the example it sets.

"It's made to appeal to kids ... I don't think it's a good thing to make cocaine cool, to glamourize it," she worries.

But would anyone actually want to take a swig? Not consumers like Jocelyn Merkley. "It's just unappealing," she responds. "I can't believe they'd ever put it in stores."

And Kaufman warns it's not just a name or a taste issue that's the problem.

"You knock back two or three of these, you might have heart palpitations, you might even have hallucinations."

So how much caffeine is too much? Here's a list of some of the most common sources of the substance and how they compare to the energy drinks.

Coffee

Brewed - 237 ml (1cup) - 135 milligrams of caffeine

Roasted and ground, percolated - 237 ml (1cup) - 118mg

Roasted and ground, filter drip - 237 ml (1cup) - 179mg

Roasted and ground, decaffeinated - 237 ml (1cup) - 3mg

Instant - 237 ml (1cup) - 76 - 106mg

Instant decaffeinated - 237 ml (1cup) - 5mg

Tea

Average blend - 237 ml (1cup) - 43mg

Green - 237 ml (1cup) - 30mg

Instant - 237 ml (1cup) - 15mg

Leaf or bag - 237 ml (1cup) - 50mg

Decaffeinated tea - 237 ml (1cup) - 0mg

Colas

Cola beverage, regular - 355ml (1 can) - 36 - 46mg

Diet cola - 355ml (1 can) - 39 - 50mg

Cocoa Products

Chocolate milk - 237ml - 8mg

1 envelope hot-cocoa mix - 237ml - 5mg

Candy, milk chocolate - 28g - 7mg

Candy, sweet chocolate - 28g - 19mg

Baking chocolate, unsweetened - 28g - 25 - 58mg

Chocolate cake - 80g - 6mg

Chocolate brownies - 42g - 10mg

Chocolate mousse - 90g - 15mg

Chocolate pudding - 145g - 9mg

Energy Drinks

Jolt Cola: 71 mg. (1 can)

Red Bull: 80 mg. (1 can)

Cocaine Energy Drink: 280 mg. (1 can)

What Is Caffeine?

Caffeine has been called the most popular drug in the world. It's a central nervous system stimulant that's derived from the coffee bean, tea leaf, kola nut and cacao pod.

Health effects of caffeine

Research has shown that people who consume too much caffeine can experience the following side effects:

• Insomnia,
• Headaches,
• Irritability,
• Nervousness,
• Abdominal or stomach pain,
• Agitation,
• Anxiety,
• Excitement,
• Restlessness,
• Confusion or delirium,
• Convulsions (seizures),
• Dehydration,
• Increased breathing rates,
• Fast or irregular heartbeat,
• Increased sensitivity to touch or pain,
• Muscle trembling or twitching,
• Nausea and vomiting.

What Is A Healthy Daily Amount Of Caffeine?

Health Canada recommends that average adults limit their daily caffeine intake to 400-450 mg. That level hasn't been associated with any adverse effects.

But the daily dosage changes if you're a woman in her child-bearing years or a child. Here's the maximum daily caffeine intake recommended for those two groups:

Children

4-6 Years: 45mg

7-9 Years: 62.5mg

10-12 Years: 300mg

Women

Women planning on getting pregnant, already pregnant or breastfeeding mothers: 300 mg

Source: Health Canada & U.S. National Institutes Of Health

Caffeine is also the subject of much speculation on the Internet. One of the strangest sites devoted to the substance has to be "Death by Caffeine", a place where you can calculate how much of the drug it would take to kill you.

Article Source: CityNews.ca Jan 12, 2007

Caffeinated Buzz???

Source: Men's Health Jan 2007

Beverage Study Results

Beverage studies tend to get sweet results: study

Does milk lower blood pressure? Does juice prevent heart disease? Beverage studies were four to eight times more likely to reach sweet conclusions about health effects when industry was footing the bill, a new report contends.

Its authors claim to have done the first systematic analysis of such studies published from 1999 through 2003 in hundreds of journals around the world.

“We found evidence that's strongly suggestive of bias,” said Dr. David Ludwig, an obesity specialist at Children's Hospital Boston who led the work, which was published Monday in the online science journal PLoS Medicine. The consumer advocacy group Center for Science in the Public Interest also participated.

Biased science can affect consumer behaviour, doctor recommendations and even federal regulation of marketing claims for such products, Dr. Ludwig said.

“I don't blame researchers for this problem. I think most are highly ethical and dedicated to science. The problem is that when government underfunds nutrition research, industry money becomes hard to resist,” he said.

However, beverage industry folks say the authors have a slant, too.

“This is yet another attack on industry by activists who demonstrate their own biases in their review by looking only at the funding source and not judging the research on its merits,” says a statement by Susan Neely, president of the American Beverage Association. “The science is what matters — nothing else.”

Public health experts who promote dietary guidelines are biased toward their own advice, said Greg Miller, a nutrition biochemist who heads research for the National Dairy Council. The council requires its funded researchers to publish results in journals that require review by outside scientists and to disclose who pays for their work.

“Everybody brings a point of view to the table, and in the long run, that's probably a good thing,” Dr. Miller said.

But the authors say this point of view appears to influence results.

They used Medline, a compendium of scientific literature, to identify 538 studies about soda, milk or juice involving people, not animals. They targeted 206 that made a health claim directly related to the drink being studied — for example, bone fractures related to calcium and milk intake, or immune system benefits from antioxidants in juice.

Of the 206 studies, only 111 gave information on funding: 22 per cent were fully funded by industry and 32 per cent got some industry money.

One group of reviewers analyzed study conclusions and classified them as favourable, neutral or unfavorable to the beverage in question. Another independent group of reviewers determined whether a study would help, harm or have no effect on the finances of the study sponsor.

For example, a negative finding about soda would harm a soda sponsor but could help a dairy producer.

Overall, studies funded entirely by industry were four to eight times more likely to be favourable to their sponsors.

None of the experiments fully funded by industry that tested beverages with a control group found fault with the drinks.

The authors' work was paid for by a grant from the Charles H. Hood Foundation, which finances research on children's issues at Dr. Ludwig's hospital. Co-author Dr. Lenard Lesser also had funding from a fellowship at the Rochester School of Medicine and Dentistry.

The beverage association complained that Dr. Ludwig is on the editorial board of the journal that published his study. However, Dr. Ludwig noted that the board has more than 100 scientists on it, and said his study went through an independent review.

Source: The Globe and Mail, Jan 09, 2007

Bill 50

Ontario regulates tradition

A new law regulating traditional Chinese medicine and acupuncture will protect Ontarians from the dangers of the current free-for-all that is plaguing the ancient practice, many long-time practitioners say.

But others contend the legislation — passed by Queen's Park and put into effect Dec. 20 — will puncture a vibrant and ballooning alternative medical therapy industry that has worked hard to earn the trust of Canadians in recent decades.

“It is a very complex issue,” said Cedric Cheung, a doctor of Chinese medicine in London and president of the Chinese Medicine and Acupuncture Association of Canada. “But it is an issue that is being addressed for the protection and the safety of the general Canadian.”

Royal assent for the controversial Bill 50 launched the process of creating a self-regulating professional body that will be known as the College of Traditional Chinese Medicine Practitioners and Acupuncturists of Ontario — similar to those that govern doctors, nurses, chiropractors and physiotherapists.

Toronto acupuncturist Paul Jang inserts needles into Steve Gillians' back to relieve pain. Mr. Jang supports the regulation of Chinese medicine. (Fred Lum/The Globe and Mail)

The college will be responsible for setting standards, licensing practitioners, establishing disciplinary procedures for malpractice or misconduct and setting up a complaints committee that will look at grievances.

“Previously, there was no restriction on who could practise traditional Chinese medicine in Ontario, or who could call themselves a practitioner. So it comes down to public protection,” said A. G. Klei, a spokesman for the Ministry of Health and Long-Term Care. Dr. Cheung, who has been practising the technique of inserting and manipulating needles into meridian points on the body for nearly 40 years, says many of the services being offered in Ontario in recent years have become very lax, too often resulting in serious injuries.

“There was a patient being treated by a practitioner with a reused disposable needle. They don't throw it away, they keep it and reuse it. Then there are cases of lung punctures with the needle. [In another case, a] needle wasn't inserted properly in the leg and it caused swelling because it was inserted in an artery.”

Because the practice was unregulated, there was no way for injured parties to file a complaint, and no one has successfully sued for malpractice.

Although the government expects it will be two to three years until the college is established, Dr. Cheung is glad to see that the process, for which he has been lobbying for more than 20 years, is finally under way. It not only protects Ontarians who are increasingly turning to alternative forms of therapy, but it also “is an official recognition of Chinese medicine, the whole regimen,” he says.

Ontario joins British Columbia as the only provinces to regulate TCM and acupuncture. Two other provinces, Alberta and Quebec, regulate only acupuncture. About 48 U.S. states, along with England and Thailand, also have some type of regulation of Chinese medicine similar to those put into effect by Bill 50.

The college will be responsible for establishing different classes of Chinese medicine practitioners to avoid having practitioners wage a turf war with chiropractors and physiotherapists for exclusive rights to practise acupuncture. The classes would differentiate between medical doctors of traditional Chinese medicine, with advanced education, and practitioners with a general education in traditional medicine.

Kin Wong, who has been running his family's South China Herbs Market in Toronto for the past 16 years, says the legislation will severely harm the way in which he can help patients because he cannot claim to be a traditional Chinese medicine practitioner, diagnose illnesses, or prescribe remedies.

Mr. Wong, 37, learned the trade from his father, who was taught by his grandfather.

Canadians are aware that many of the herbs used in Chinese medicine aren't scientifically tested, he says — people choose to go into shops such as his.

“I'm more than willing to put a sign up in my window that says these medicines have not been tested and that people are venturing into uncharted territory,” Mr. Wong says.

He is worried that the red tape that will come with the college will scare many traditional Chinese medicine practitioners out of their profession and will mark the end of the industry “in a few years.

Paul Jang, a Toronto acupuncturist who is a strong supporter of the legislation, agrees that the new rules will take a toll on the industry. Of the roughly 3,000 practitioners across Ontario, Mr. Jang estimates only 800 will be qualified enough to become licensed under new regulations because many of those currently practising do it part-time and don't have more than a year of specialized training.

“The people who don't like Bill 50 are the ones who are scared they won't be able to practise any more. The ones with the right qualifications have nothing to worry about,” he said through a translator in his clinic.

Wheat Gain

Source: Men's Health Jan 2007

Anti-Obesity Pill

Anti-obesity drug no magic bullet

Some doctors in Canada are worried about the side-effects of an anti-obesity drug that is expected to hit the market in the U.S. by spring 2008.

Known in Europe as Acomplia and generically as rimonabant, the drug helps people to lose weight, controls Type 2 diabetes, raises high-density lipoprotein or HDL "good" cholesterol and tells the brain to stop craving food and cigarettes.

The drug has not been approved in North America, although both the U.S. Food and Drug Administration and Health Canada are studying it.

Rimonabant works by blocking cannabinoid receptors in the brain that cause cravings. It also affects other organs such as the liver and pancreas that control blood fats and insulin levels.

It works differently than other anti-obesity drugs but seems to have many of the same side-effects, such as nausea and diarrhea. People taking rimonabant also have a tendency to get anxious and depressed.

The drug's manufacturer, Sanofi-Aventis, does not want to see the drug used indiscriminately.

"This drug is not aiming for casual weight-loss," said Dr. Josée Dubuc-Lissoir of Sanofi-Aventis in Montreal. "This drug is aiming to decrease the risks of having heart attacks and diabetes."

No major weight loss

In clinical trials, obese people taking rimonabant lost about five per cent of their body weight and maintained the weight loss for a year. If patients stop taking the drug, the pounds come back, just as they would if they stopped dieting and exercising.

Clinical trial participants took the drug along with diet and exercise, and the combination approach is needed to lose weight and keep it off, said endocrinologist Dr. Ehud Ur of Dalhousie University in Halifax.

The drug needs to be combined with diet and exercise, says endocrinologist Dr. Ehud Ur of Dalhousie University in Halifax.
(CBC)

"Any notion that this is the magic bullet really needs to be wiped out because I think that's setting us up for inappropriate expectations," Ur cautioned.

Jane Jones of London, England, has lost nine kilograms or 20 pounds in four months on rimonabant. She went on the drug to control her Type 2 diabetes.

"I reckon I'm eating probably nearly a whole meal less during the day because the meals are smaller," said Jones. "It's reduced my intake."

Such weight loss is particularly important for people carrying belly fat, which is linked to an increased risk of heart attacks and strokes.

Some doctors are alarmed at the thought of millions of people worldwide taking a drug for diabetes and obesity indefinitely, but many analysts expect that the drug will earn Sanofi-Aventis $5 billion a year in the U.S. alone.

Source: CBC

Natural High?

Source: Men's Health Jan. 2007

Open Mind

source: TIME A to Z Health Guide