Health Canada probing potential link between diabetes drug and cancer

From the Canadian Press:
Health Canada is investigating the diabetes drug Lantus after research suggested there may be an increased risk of developing various types of cancer among those taking the medication.

Lantus is a long-acting synthetic insulin similar to human insulin that is used to control blood sugar in people with Type 1 and Type 2 diabetes. It has been marketed in Canada since February 2005 by Sanofi-Aventis.

The U.S. Food and Drug Administration and the European Medicines Agency recently announced they would be reviewing Lantus (insulin glargine) after four studies looked at the potential link between the drug and cancer in diabetics.

"Three of the four studies suggested a very slightly increased risk of cancer associated with use of Lantus, while the fourth study found no link between the drug and the development of cancer," Health Canada said in an advisory Thursday. ...more

Blood test may miss statin-related muscle injury: study

From CBC News:
Muscle damage related to the use of statins is not uncommon, but now researchers say tissue classified as injured by the cholesterol-lowering drugs can't always be detected through a standard blood test.

Studies suggest 10 to 15 per cent of people taking statins experience some kind of muscle pain or weakness as a side effect of the treatment. A smaller but unknown percentage have stronger, persistent pain, called myopathy.

If doctors suspect statins are causing pain, they usually test for an enzyme in the blood known as creatin phosphokinase (CPK), which leaks from damaged muscles.

But a study by U.S. and Swiss researchers published in the July 7 issue of the Canadian Medical Association Journal found muscle damage even when tests came back negative for elevated levels of serum CPK.

The researchers looked at leg muscle biopsies from 44 people who had "clinically diagnosed statin-associated myopathy" and were either currently taking statins or had recently taken them.

They found that 25 of those patients also had muscle injury, in spite of normal blood tests. Only one patient with "structural injury" had a circulating level of creatine phosphokinase that was elevated more than the upper limit of normal, the researchers said. ...more

Asthma drug linked to suicide attempts, thoughts of self-harm

From Canada.com:
The side-effects of a popular asthma medication that has been sold in Canada for 12 years has been linked to suicide attempts and thoughts of suicide, as well as feelings of depression and hostility.

The July 2009 issue of the Canadian Adverse Reaction Newsletter from Health Canada cites montelukast sodium — which has been marketed in Canada since 1997 as Singulair — as having several connections to the alarming reactions.

Between its introduction to the Canadian market and Jan. 31, 2009, Singulair has been linked to two suicide attempts in Canada and 11 cases where users had thoughts of suicide or self-harm. In 29 other cases, 14 of which were labelled as "serious adverse reactions," those affected suffered from depression, hostility or other psychosis. No deaths have been linked to the drug's side-effects. ...more

Drug regulators seek curbs on acetaminophen products

From the Calgary Herald:
American drug regulators are considering pulling some products with acetaminophen off the shelves and Health Canada is keeping a close eye on the deliberations as it also moves to warn consumers about the risk of liver damage due to an overdose of the drug.

Acetaminophen, widely used as a pain reliever and to reduce fever, is generally a safe and effective drug, according to the U.S. Food and Drug Administration, but when a patient exceeds the recommended dosage, it has been known to cause abnormalities in liver function, liver failure and death.

The FDA has made various efforts since the 1990s to stem what it calls "a public health concern," but it has been unsuccessful in reducing the number of cases of liver damage related to the drug. ..more

Medication a defence for punching the boss

From the National Post:
A labour arbitrator has reversed the firing of a veteran elementary-school janitor who sucker punched his boss, ruling that an experimental arthritis drug the man was taking as part of a clinical trial helped trigger the angry outburst.

It may be the first time in a Canadian legal hearing that pharmaceutical adverse effects have been successfully invoked to justify violent behaviour.

The custodian, Alf Clayfield, had put in 22 years of generally exemplary service with an Ontario school board before the October incident with his manager.

He acted out of character partly because of the medicine's neurological side effects, the arbitrator said in replacing the dismissal with a three-month suspension.

Mr. Clayfield said the problems he attributes to the drug began with insomnia, headaches and dizziness. "I found that things that never bothered me before would irritate me very quickly," the Kitchener-Waterloo public school board employee said in an interview. ...more

Study shows seniors not always aware of drug risks

From the Naniamo (BC) Daily News:
Although past studies have shown drug side-effects to be the No. 1 reason seniors are hospitalized, most don't understand the risks associated with adverse drug reactions or how to avoid them, according to research by the University of Victoria's Centre on Aging.

Anthropology professor Peter Stephenson and a team of researchers conducted in-depth interviews with 20 seniors in Parksville and Qualicum Beach in the fall to gauge their attitudes toward medication. Preliminary results show elderly people also often don't have someone they can rely on who could look at all of their health products and possible interactions.

Earlier this week, a Statistics Canada report showed that Canadians 80 and older fill five times as many drug prescriptions a year as the average person, while a study published last year by the Canadian Medical Association Journal said that adverse drug reactions accounted for 12% of all emergency-room visits.

Stephenson said more education is needed on the issue, not only for seniors but also medical professionals who are tasked with writing and handling prescriptions.

"The pharmacist usually gives them a fairly minimal accounting of things. They're often rushed (because) they have many people coming in," he said. ...more

MP calls for independent drug agency following daughter's death

From the Vancouver Sun:
Nine years after vowing to find out why his healthy teenage daughter died while taking a popular prescription drug, a rookie MP is launching a campaign to persuade the Harper government to establish an independent drug safety agency in Canada.

Terence Young, Conservative MP for Oakville, Ont., is making his pitch for the agency in a new book that details his battle with "Big Pharma" and the health agencies and professionals that are charged with protecting patients like his daughter Vanessa.

Next week, he will introduce a motion in the House of Commons, where he hopes MPs from all parties will support his push for drug safety reform.

"This is a non-partisan issue. I will be appealing to all my colleagues in Parliament to create an independent drug agency to deal with these issues and make Canadians safer," Young said in an interview. "It's my goal, my dream, to have a consensus in Parliament to move forward on this."

The MP says his book, Death by Prescription: A Father Takes on his Daughter's Killer - The Multi-Billion-Dollar Pharmaceutical Industry, officially released Tuesday, is the culmination of his efforts to "uncover the truth" about why his 15-year-old daughter's heart stopped and she collapsed before his eyes on March 19, 2000. ...more

Seniors most likely hospitalized for adverse drug reactions: StatsCan

From the Calgary Herald:
Canadians aged 80 and older fill five times as many drug prescriptions a year as the average person, according to new data from Statistics Canada, helping explain why drug side effects are the No. 1 reason they visit emergency rooms.

In 2005, pharmacists filled an average of 74 prescriptions for each person over the age of 80, compared with an average of 14 prescriptions per Canadian, said the Statistics Canada study.

Typically, seniors on multiple drugs see numerous specialists who prescribe various medications to treat a range of chronic ailments: high blood pressure, hypertension, diabetes, Alzheimer's, arthritis, heart disease and stroke.

Experts have long known that seniors are the major consumers of drugs, but the Statistics Canada study is the first to quantify it nationally.

A study published last year by the Canadian Medical Association Journal revealed that adverse drug reactions accounted for 12 per cent, or more than one in nine, of all emergency-room visits. ...more

Grapefruit, birth control pill interaction may have caused weird blood clot case

From the Canadian Press:
Chalk another one up to the bizarre power grapefruit and grapefruit juice have to mess around with medications.

An American woman in her 40s nearly lost a leg to gangrene because of a confluence of health factors exacerbated by a diet that included daily doses of grapefruit, the doctors who treated her reported in a medical journal on Friday.

"The way I think of it actually is like she's a setup for the perfect storm. And I believe it was the grapefruit that tipped the balance," Dr. Lucinda Grande, a medical resident at Providence St. Peter Hospital in Olympia, Wa., explained in an interview.

Grande is the first author on the case report, which appears in this week's issue of The Lancet.

The woman, then 42, arrived at the hospital's emergency room last November with a badly swollen and discoloured left leg. She was experiencing shortness of breath and light-headedness.

Doctors diagnosed a large deep vein thrombosis - a dangerous blood clot - in her left leg, running all the way from her hip to her calf. Because of the condition of the leg, the doctors treating her were worried she might be developing irreversible gangrene that would force amputation of the limb. ...more

Smoking-cessation drug under scrutiny

From CTV Calgary:
Hundreds of people claim a drug used to help people quit smoking has given them some serious side effects.

Dana Roy says she tried to slit her wrists while she was taking the drug Champix. She says "I looked down at the sink and this knife was sitting here, and I picked it up and cut both my wrists".

Roy says "I had such an overwhelming feeling of anxiety; I just wanted the feeling to go away".

Roy's medication did come with an information sheet that described common side effects such as nausea and trouble sleeping. It also said "tell your doctor if you experience agitation, depressed mood or suicidal thoughts" the sheet also says "it's not known if these symptoms are related to Champix". ...more

Updated Safety Information regarding Progressive Multifocal Leukoencephalopathy (PML) associated with TYSABRI® (natalizumab)

From Health Canada:
Biogen Idec Canada Inc., in consultation with Health Canada, would like to inform you that previously communicated safety information regarding post-marketing reports of PML in patients receiving TYSABRI® (natalizumab) monotherapy is now included in the Canadian Product Monograph. PML is a known risk of TYSABRI therapy.

TYSABRI is a humanized monoclonal antibody and is currently authorized as monotherapy (i.e. single disease-modifying agent) for the treatment of patients with relapsing-remitting multiple sclerosis (MS) to reduce the frequency of clinical exacerbations, to decrease the number and volume of active brain lesions identified on magnetic resonance imaging (MRI) scans and to delay the progression of physical disability.
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HIV drug could raise heart attack risk

From the Irish Times:
A widely used anti-HIV drug could raise heart attack risk by encouraging blood clots to form, according to a new study by Irish scientists that was unveiled at a major international conference in Canada last week.

The Dublin-based researchers showed that patients on the anti-viral drug Abacavir have stickier blood platelets – which can clump to form clots – than patients who are not taking that drug as part of their therapy.

HIV infection itself is thought to increase heart attack risk, but last year a Danish-led study of more than 30,000 HIV-infected patients found that Abacavir appeared to almost double that risk, said Dr Paddy Mallon, consultant in infectious diseases at the Mater Misericordiae Hospital and a lecturer in medicine at University College Dublin. ...more

Some anti-acid meds may reduce Plavix efficacy

From CTV News:
Patients who are prescribed popular blood-thinning drug to prevent a heart attack while at the same time take certain anti-acid medications may actually boost their risk of having a heart attack, a new study suggests.

Canadian researchers have found that heart attack patients who take the blood-thinning drug clopidogrel (Plavix) have a 40 per cent greater risk of suffering another heart attack if they are also taking one of a number of proton-pump inhibitors (PPIs).

PPIs block the production of stomach acid and are used to treat conditions such as ulcers and acid reflux disease.

The PPIs linked to the increased heart attack risk are: omeprazole (Losec), lansoprazole (Prevacid) and rabeprazole (Pariet).

The researchers, who hail from the Institute for Clinical Evaluative Sciences (ICES) in Toronto, say that they did not find an increased heart attack risk among patients taking the PPI pantoprazole (Pantoloc). They also did not find an increased risk among patients taking anti-acid medications known as H2 receptor antagonists, such as Pepcid or Zantac. ...more

Drug pairing boosts heart risk

From the Toronto Star:
Heart patients on a popular combination of high blood pressure drugs have an increased risk of heart attacks and other ailments from the coupled medications and should see their doctor as soon as possible, new guidelines from the Canadian Heart and Stroke Foundation say.

Taking a cue from a massive study released last year, the foundation's recommendations should all but eliminate the practice of prescribing so-called ACE inhibitors and ARBs together, organization officials said.

"When you put the two drugs together, you don't get a synergy of effect; all you do is get the side effects of both adding up," said Dr. Sheldon Tobe, a foundation spokesperson.

"So there's a doubling up of the side effects as opposed to a doubling up of the benefits," he said.

The study looked at nearly 26,000 patients and tested the effectiveness of the two drugs separately and together.

It determined that the treatment combo produced only minimal improvements in blood pressure, Tobe said. The risks, however, of heart attacks and kidney disease increased. ...more

Feds pour $32 million into drug monitoring

From Canada.com:
The federal government unveiled details Wednesday and announced more funding for its plan to better monitor the safety of drugs once they are on the market.

Health Minister Leona Aglukkaq said the government is spending $32 million over the next five years to support the new Drug Safety and Effectiveness Network, and will devote $10 million every year afterwards to the initiative that was first announced in July.

Health Canada and the Canadian Institutes of Health Research, a federal agency, will put the finishing touches on the new network in the coming months. That will involve creating a virtual network to link researchers, setting up an office at the CIHR and hiring a committee that will help determine a research agenda based on priorities identified by decision-makers. ...more

Botox chemical may spread, Health Canada confirms

From CBC News:
The toxin in Botox products may spread to distant parts of the body, with potentially fatal consequences, Health Canada said Tuesday in announcing new labelling information for the drugs.

Last February, the U.S. Food and Drug Administration said the toxin had spread, both in products the agency approved and those that were not. Health Canada has been reviewing the safety of Botox and Botox Cosmetic.

No medically confirmed cases of the toxin having spread have been reported in Canada. ...more

Health Canada Reminds Canadians of Important Safety Information For the Smoking-Cessation Aid Champix

From Health Canada:
Health Canada is reminding Canadians who are taking, or considering taking, the smoking-cessation aid Champix of important safety information for this product. Health Canada is also informing Canadians that it is in the process of further strengthening the labelling for the drug with respect to the risk of serious psychiatric adverse effects.

While Champix (the brand name for varenicline tartrate) can be an effective tool for quitting smoking when used as part of a support program, there have been reports in some patients of unusual feelings of agitation, depressed mood, hostility, changes in behaviour, or impulsive or disturbing thoughts such as thoughts of self-harm or harm to others. It is unclear at this time whether Champix is the cause of these psychiatric symptoms. ...more

Natural sleep aid linked to nightmares

From the Globe and Mail:
Valerian, a herbal sleep aid commonly used by those who want an alternative to prescription sedatives, has been linked to serious side effects, according to Health Canada, raising questions about the safety of some natural health products.

Health Canada said it has received more than 30 reports of adverse reactions, including hallucinations and nightmares, linked to valerian from 2003 to 2008. The department also warned in a quarterly adverse-reaction newsletter that some medical studies have found an association between valerian and hallucinations, delirium and cardiac complications.

Health Canada also said it had received more than 50 reports of adverse reactions involving echinacea, ginkgo and St. John's wort in the same time period, including agitation, dizziness, rash and pain.

An increasing number of Canadians are using vitamins, supplements and other natural health products on a regular basis.

The industry's retail sales are expected to reach more than $2.75-billion by 2010, according to the Canadian Health Food Association.

But the rapid growth has many members of the medical community concerned. That's because data used to demonstrate that natural health products work are often limited and sometimes weak. More troubling to some is the fact that many consumers have come to rely on daily vitamins and supplements without realizing such products can have serious side effects or interactions with food or drugs. ...more

Champix side effects prompt 818 complaints

From the Globe and Mail:
Health Canada has received more than 800 reports of side effects - including more than 500 reports of psychiatric problems - linked to the controversial smoking-cessation drug Champix in less than two years on the market.

But although evidence is growing that the medication is linked to aggression, depression and suicidal tendencies, some tobacco-control experts and non-profit groups in Canada still encourage its use, often without mention of the possibility of psychiatric problems.

In its online guide to quitting smoking, forexample, the Canadian Lung Association includes a section that lists Champix first as an effective option to "reduce cravings and withdrawal symptoms."

The association says the "pros" of Champix include the fact it is in pill form and is easy to use, as well as the fact it is not addictive because it doesn't contain nicotine. The guide lists only minor side effects, such as nausea, strange dreams and constipation, as "cons" to taking Champix, even though Health Canada has issued two warnings in recent months about links between the drug and serious psychiatric side effects.

The smoking and tobacco section of the website indicates that Pfizer Canada, which sells Champix, provided funding to the association in the form of a restricted educational grant, which means that Pfizer isn't involved in how the money is spent. ...more

Avoid antipsychotic drugs for elderly, experts urge, after death risk study

From CBC News:
Doctors should try not to prescribe antipsychotic drugs for elderly people with Alzheimer's, geriatricians said following new research that concluded taking people taking the medications had double the risk of dying during the course of the study.

Anti-psychotic medications are sometimes given to control symptoms of dementia in elderly patients, such as wandering and aggressiveness. Generally, the drugs work by subduing the patients, making them easier to manage in facilities such as nursing homes.

In the study appearing in Friday's issue of the medical journal Lancet Neurology, researchers followed 165 patients in Britain aged 67 to 100 with moderate to severe Alzheimer's disease from 2001 to 2004.

Half of the participants continued taking their antipsychotic medications, including Risperdal (risperidone), Thorazine (chlorpromazine) and Stelazine (trifluoperazine). The other half got placebos. ...more