Blood Pressure Drug Combo Can Be Deadly

Blood-pressure drug alert issued

Taking two commonly prescribed blood-pressure drugs in combination can trigger severe heart and kidney problems, according to an alert issued Friday to patients and physicians.

The drugs, angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers, are considered safe and effective on their own and when combined with other hypertension drugs, but ACE inhibitors and ARBs should not be used together, the Heart and Stroke Foundation is warning.

The group estimates that about 175,000 Canadians – most of them over the age of 65 – are taking this particular combination of drugs.

“This is a safety issue that the public and practitioners need to be aware of,” said Sheldon Tobe, a nephrologist at Sunnybrook Health Sciences Centre in Toronto. “Bringing blood pressure under control is very important, but with this particular combination the potential risks outweigh the benefits.”

Margaret Moy Lum-Kwong, director of high-blood-pressure strategy at the Heart and Stroke Foundation of Ontario, stressed that patients should not stop taking medications, even if they are taking ARBs and ACE inhibitors together, but discuss the matter with their physician.

“If you are on this particular combination treatment … go directly to your doctor for an alternative treatment,” she said.

High blood pressure, the leading risk factor for heart disease, is commonplace, affecting one in four men and one in five women.

A person is considered hypertensive with a blood-pressure reading of 140/90 millimetres of mercury (mmHg) or higher. Healthy adults should have a blood pressure in the range of 120/80 mmHg, although that target varies with age and other health conditions such as diabetes.

According to a study published last year, about 85 per cent of those with high blood pressure are aware of their condition and most are being treated successfully.

Blood pressure can often be controlled with lifestyle changes such as weight loss, healthy eating (particularly reducing salt consumption) and exercise, but many Canadians are treated with prescription drugs.

About two-thirds of hypertensive cases are treated with combinations of drugs, including diuretics, ACE inhibitors, ARBs and calcium channel blockers.

The safety and effectiveness of various combinations is being studied systematically. Last year, a landmark Canadian-led study showed that the combination of an ACE inhibitor and ARB was only marginally more effective at lowering blood pressure than either drug taken alone.

But it also revealed far more side effects among those taking the ACE-ARB combo, including fainting, diarrhea and dangerously elevated potassium levels that could result in kidney failure (and the need for dialysis) and even death.

Dr. Tobe stressed that severe complications were rare, but said there is no justification for putting patients at risk when there is no additional benefit.

“What we're doing here is refining therapy to make it safer,” he said.

Arthur Innes, a 57-year-old Torontonian who works in a long-term care facility, said he got his blood pressure checked as part of a physical for life insurance and was shocked to learn readings were dangerously high at 200/90 mm/Hg.

His family doctor prescribed a combination of ARB and ACE inhibitor. “These medications didn't make me feel very good. I was dizzy and had nausea all the time,” Mr. Innes said.

He was referred to a specialist and prescribed different medication; he now has his blood pressure under control and suffers no side effects.

“Taking the meds is important for your heart,” Mr. Innes said, “but you don't want medications that impair your way of life.”

Source: theGlobeandMail.ca

Health Canada Warning

Jin Bu Huan Anodyne tablets recalled: Health Canada

Health Canada is warning consumers not to use Jin Bu Huan Anodyne tablets after two reported adverse reactions in this country.

The Canadian importer, Wing Quon Enterprises Ltd., has initiated a recall of the product — unauthorized for use in Canada — as the federal agency says it contains an undeclared ingredient (tetrahydropalmatine).

Health Canada says the amount of the chemical tetrahydropalmatine, contained in a daily dose of the tablets, has been associated with liver injury in adults, and brain and nervous system injury in children and adults.

It's also been associated with adverse reactions such as fever, nausea, vomiting, abdominal pain, and diarrhoea.

The product label also promotes unauthorized use in the treatment of ulcer pain, and abdominal pain after childbirth.

Health Canada wants retailers to pull the herbal treatment from store shelves, and advises consumers who have taken the tablets to discontinue use immediately and consult a health-care professional.

Source: CBC.ca

Anti-Smoking Drug's Adverse Effects

Smoking drug Champix linked to adverse psychiatric effects: Health Canada

Health Canada has issued a warning about adverse neuropsychiatric effects linked to Champix, a drug intended to help smokers butt out for good.

A number of patients taking Champix (varenicline tartrate) have experienced unusual feelings of agitation, depressed mood, hostility, changes in behaviour or impulsive or disturbing thoughts, such as ideas of self-harm or of harming others, Health Canada said Friday in an advisory.

The medication acts on sites in the brain affected by nicotine. The drug helps ease withdrawal symptoms and blocks the effects of nicotine if users resume smoking.

Champix, made by Pfizer Inc. and sold under the brand name Chantix in the United States, has been sold in Canada since April 2007. In the year following its approval, 226 Canadian cases of neuropsychiatric adverse events have been reported. In that period, more than 708,500 prescriptions for the drug have been filled across the country.

Health Canada issued the following guidelines to the public:

• Tell your doctor if you have experienced depression or other mental health problems before taking Champix, as these symptoms may worsen while taking the drug.
• Stop taking Champix and tell your doctor right away if you, your family or caregiver have noticed any of these symptoms, if you experienced these symptoms in a way that is not typical for you or if you have thoughts of self-harm or of harming others.
• Champix has not been studied in people with mental health problems, and therefore your doctor will be monitoring you closely for new or worsened emotional or behavioural problems while on the medication.

"Quitting smoking can also be associated with changes in mood and behaviour, with or without taking medication to help quit," said the federal department in its advisory. "A doctor or pharmacist should be consulted should these symptoms or those described above be experienced, since guidance has been provided to health-care professionals on how to use Champix in patients, including those patients who may also have mental health problems."

Health Canada, which published an article concerning Champix in the Canadian Adverse Reaction Newsletter in April, said any case of serious change in mood or behaviour or other serious or unexpected adverse reactions in patients receiving Champix should be reported.

Source:CBC.ca

Supplement MisLabelling

Source: Women's Health April 2008

Ban Demand: 8 Dyes Linked Problematic Child Behaviour

Consumer group calls on FDA to outlaw food dyes

A consumer advocacy group called on the Food and Drug Administration Tuesday to ban the use of eight artificial colourings in food because the additives may cause hyperactivity and behaviour problems in some children.

Controlled studies conducted over three decades have shown that children's behaviour can be worsened by some artificial dyes, says the Center for Science in the Public Interest. The group noted the British government is successfully pressuring food manufacturers to switch to safer colourings.

Over the years, the FDA has consistently disputed the centre's assertion. The agency's website contains a 2004 brochure that asks the question: "Do additives cause childhood hyperactivity?"

"No. Although this hypothesis was popularized in the 1970s, well-controlled studies conducted since then have produced no evidence that food additives cause hyperactivity or learning disabilities in children," the agency said.

Julie Zawisza, an FDA spokeswoman, said Tuesday that color additives undergo safety reviews before approval for marketing and that samples of each artificial colouring are tested. She said the agency reviewed one of the studies the centre cites in calling for a ban.

"[We] didn't find a reason to change our conclusions that the ingredients are safe for the general population," Zawisza said. "Also note that the European Food Safety Agency has a similar view as FDA's."

Dyes are used in countless foods and sometimes used to simulate the colour of fruits or vegetables. The additives are particularly prevalent in the cereals, candies, sodas and snack foods pitched to kids.

"The purpose of these chemicals is often to mask the absence of real food, to increase the appeal of a low-nutrition product to children, or both," said Michael F. Jacobson, the centre's executive director.

"Who can tell the parents of kids with behavioural problems that this is truly worth the risk?"

The centre's petition asks the FDA to require a warning label on foods with artificial dyes while it mulls the group's request to ban the dyes outright.

The colourings the centre seeks to ban are:

• Yellow 5
• Red 40
• Blue 1
• Blue 2
• Green 3
• Orange B
• Red 3
• Yellow 6
  

Source: CBC.ca

Potential Psych Warning On Flu Drugs - FDA

FDA mulls psych warning for 2 flu drugs

U.S. Food and Drug Administration staff have recommended new warnings about psychiatric side effects seen in some patients taking Tamiflu and Relenza, according to documents released Friday.

An FDA advisory panel will review the recommendations for the anti-viral influenza drugs at a meeting next week.

It based its recommendations on a review of nearly 600 cases of neuropsychiatric events reported by patients on Tamiflu and 115 cases of such events by patients taking Relenza.

In the case of Tamiflu, "the number of cases continues to increase," FDA staff wrote, in one of several documents posted ahead of the meeting.

The panel meeting will be the third public meeting on the safety of Roche Holding AG's Tamiflu, originally prompted by reports two years ago of a dozen deaths of children in Japan who had been taking the drug.

Experts then found no evidence of a direct connection between the drug and the deaths, although the FDA did ultimately update Tamiflu's label to add a caution urging close monitoring of patients for abnormal behaviour such as delirium or self-injury.

In documents prepared for the meeting next week and posted on the FDA's Web site, agency staff recommended that Tamiflu's label be strengthened further to note: "In some cases, these behaviors resulted in serious injuries, including death, in adult and pediatric patients."

Consumer group Public Citizen chided the agency for failing to note the reported adverse events earlier on the label.

"What is the justification for not warning people for these adverse events that have clearly occurred?" said Dr. Sidney Wolfe, head of Public Citizen's health research arm.

"Japan has said, 'stop using the drug if these things occur.' In [the U.S.], we haven't even mentioned that deaths have occurred."

Hallucinations, delirum seen in Relenza patients

In March, Japan warned against prescribing Tamiflu to young people aged 10 to 19 as more than 100 individuals, mostly young, showed signs of abnormal behaviour after taking the drug.

Earlier this year, Japan broadened its probe of Tamiflu to look at amantadine and GlaxoSmithKline Plc's Relenza.

The FDA staff also reviewed Relenza, a drug in the same class as Tamiflu, recommending its label be changed to note "reports of hallucinations, delirium and abnormal behaviour" observed in some patients taking the drug.

The current Relenza label has no label warning related to psychiatric events.

The FDA staff said the evidence is "conflicting" as to whether the events are medication-related, a manifestation of disease or a combination of the two.

It will present the advice to the advisory panel of experts meeting on Tuesday. The agency typically takes the advice of these panels but is not bound by them.
Source: CBC.ca

Drug for Neurodegenerative Disease potentially Harmful

Drug tested on neurodegenerative diseases could be harmful: scientists

Minocycline, an antibiotic being tested as a possible treatment for a variety of neurodegenerative diseases, may actually cause harm, a group of U.S. scientists has warned.

The scientists reported that in a clinical trial of patients with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, those who received the drug minocycline declined more rapidly than those who received a placebo.

Their report, published Thursday in the journal Lancet Neurology, comes just a week after the Multiple Sclerosis Society of Canada announced it was funding a multi-centre Phase 3 trial to look at whether the inexpensive and off-patent minocycline can slow the progression of MS when treatment is started in the earliest stages of the disease.

One of the lead researchers in the MS study, Dr. Wee Yong of the University of Calgary, admitted the U.S. findings gave him pause when he heard them presented in April at a meeting of the American Academy of Neurology.

But Yong said he thinks the trial should proceed. "We will of course be cautious," Yong said in an interview. "We are always cautious in a clinical trial. But we don't really want to kill anything too early because of what is observed in another context which may not have any bearing to the current condition that we're trying to treat."

"I should point out that we are dealing with different diseases altogether. The pathology or the reason for ALS is very much different from the pathophysiology of MS."

The U.S. researchers were studying minocycline as a possible therapy for ALS, a progressive and eventually fatal degeneration of motor neurons that destroys the brain's ability to instruct the body to move.

The study was led out of Columbia University Medical Center in New York, but involved investigators from medical institutions across the United States.

Early tests positive

Testing in mice genetically engineered to suffer from ALS showed the drug was beneficial. Likewise, early testing in humans — the small Phase 1 and 2 trials designed to establish safety and look for early signs of effectiveness — were sufficiently positive to allow the researchers to proceed to a larger and more expensive Phase 3 trial.

But there, to their surprise, they discovered that people taking the drug declined and died more rapidly than people who received a placebo.

"We were shocked. We were just absolutely stunned when we saw these results," one of the lead investigators, Dr. Robert Miller, said from San Francisco, where he is director of the Forbes Norris ALS Research Center at California Pacific Medical Center Research Institute.

"That was our first thought. But our second thought was that we need to get these results out because we need to avoid this happening to other people with other diseases."

Miller and his co-authors acknowledge in their article that their animal model might have been faulty, or they might have been using too high a dose of the drug.

But they also cautioned researchers who are studying minocycline as a potential therapy for conditions such as Parkinson's and Huntington's diseases, stroke and MS to take note of their results.

"The justification for these trials should be reassessed in light of our findings: Minocycline might have a detrimental effect on patients with neurological diseases other than ALS," they wrote.

Yong and his colleagues have also conducted animal studies and Phase 1 and 2 clinical trials in humans and have seen nothing that suggests minocycline would be harmful in MS patients.

Source: CBC.ca

Stomach Drugs may lead to Heart Risks

Health Canada investigates Losec, Nexium for heart risks

Health Canada is alerting consumers who take Losec and Nexium, two prescription medications primarily used to treat acid-related stomach disorders, that it is investigating the drugs' links to serious cardiac problems.

Studies of the two medications reveal that patients using Losec or Nexium to treat gastroesophageal reflux disease (GERD) instead of surgery "may have experienced more heart attacks or cardiac deaths than patients who had the surgery," reads the advisory.

It also notes that many patients who developed cardiac problems had risk factors prior to beginning treatment.

The data being reviewed by Health Canada comes from a study that compares treatment with Losec to surgery in patients with severe GERD. Another continuing study comparing Nexium to surgery has five-year followup information on patients.

The study designs did not provide for a clear definition of cardiac problems or an adequate followup of patients. While both studies include some safety data, Health Canada said it is difficult to evaluate this data because of the way it was collected, reported and documented.

At this point, Health Canada's preliminary review finds the evidence provided does not confirm the existence of a possible cardiovascular risk. It plans to complete its analysis of the new information by the end of the year and will advise Canadians of its conclusions and recommendations at that time.

Health Canada is advising health professionals not to change their prescribing practices of the drugs for the time being.

Patients taking Losec or Nexium are also urged to consult with their doctors before making any change to their medication, as GERD can lead to other complications if left untreated.

Any adverse reactions to either drug should be reported to the Canadian Adverse Drug Reaction Monitoring Program, said Health Canada.

Source: CBC.ca

Addictive Sleep Aid Warning

Consumers who use Optimum Health Care SleePlus TCM or BYL SleePlus are being warned that the sleep supplements could be addictive when used continually over a period of a few months, Health Canada says.

The federal agency said in an advisory issued Thursday that the sleep aids, which have not been authorized for sale in Canada, contain the drug clonazepam. Patients should only take products containing clonazepam under the supervision of a health-care professional.

Optimum Health Care SleePlus TCM products were sold through the Vancouver clinic Optimum Health Care. BYL Pharmaceuticals Ltd. distributed its BYL SleePlus products to other retailers. Both packages were labelled with Chinese script.

Consumers should talk to a health-care professional before they discontinue use of the sleep aids and return the products to the retailer.

Side-effects of the drug include dizziness, drowsiness, confusion, depression, loss of memory and hallucinations.

No adverse reactions linked to the use of the products have been reported in Canada.

Consumers with questions can call Health Canada at (613) 957-2991, or toll free at 1-866-225-0709.

Source: CBC.ca

Medications and Sunburnt Effects

Some Medications Can Make You More Vulnerable To Sunburn

Thursday May 24, 2007

You know the drill - don't go outside in this blazing heat without sunscreen on to protect you from the dangers of sunburn. But even as you lather on the lotion, there are other concerns that what's inside you may be as important as what's on you.

And it all depends on which medications you're taking. There are certain pills and potions that may be good for your health, but leave you much more prone to getting a burn. Some meds actually increase your skin's sensitivity to sunlight, and allow you to skip the tanning stage and head straight to a burn. It may also lower the amount of time you can spend under Old Sol without coming out beet red - or worse.

So what are the musts to avoid when it comes to exposing yourself to the elements? Here are few to watch out for:

Brand Name	Generic Name	Therapeutic Class
Motrin	ibuprofen	NSAID, antiarthritic
Crystodigin	digitoxin	antiarrhythmic
Sinequan	doxepin	antidepressant
Cordarone	amiodarone	antiarrhythmic
Bactrim	trimethoprim	antibiotic
Diabinese	chlorpropamide	antidiabetic (oral)
Feldene	piroxicam	NSAID, antiarthritic
Vibramycin	doxycycline	antibiotic
Phenergan	promethazine	antihistamine

Source: U.S. FDA and Citynews.ca

Parkinson's Drug Withdrawn from Market

Health Canada is informing Canadians that Permax, a drug used for the treatment of Parkinson's disease, has been withdrawn from the U.S. market amidst concerns about an association with cardiac valvulopathy, a condition involving inflammation or stiffening of the heart valves.

Multiple Risks associated with Another Sexual Performance Aid

Health Canada warns Canadians not to use the sexual enhancer Vigorect Oral Gel Shooter due to potential health risks.

Health Canada is warning consumers not to use the unauthorized product Vigorect Oral Gel Shooter, because it contains an undeclared drug substance tadalafil, which should only be available by prescription. The use of Vigorect Oral Gel Shooter could pose serious health risks, especially for patients with existing medical conditions such as heart problems, those taking heart medication, or those at risk of stroke.

Sexual Enhancer Heart Problems Warning

Health Canada warns Canadians not to use the sexual enhancer XOX For Men, due to potential health risks

Health Canada is warning consumers not to use the unauthorized natural health product XOX For Men, because it contains an undeclared pharmaceutical ingredient, tadalafil, an ingredient found in the prescription drug Cialis. The use of XOX For Men could pose serious health risks, especially for patients with existing medical conditions such as heart problems, those taking heart medication, or those at risk of stroke.

Drug Regulation Transparency??

Health Canada proposes progressive drug licensing

Health Canada is considering changing its system of licensing prescription drugs, moving to one in which the safety and effectiveness of medicines would be more closely monitored after products are approved for sale.

A discussion paper proposes progressive licensing for drugs to allow follow-up once they are being taken by large numbers of people.

'Drug companies do have to report to Health Canada around spontaneously reported events, but those are under-reported.'— Dr. Andreas Laupacis comments on current system

Clinical trials done before drugs are brought to market are typically small; rare side-effects generally only come to light when medications are taken by many thousands of people.

The aim is to improve the ability of the regulatory system to monitor the safety of medication during the entire life cycle of a drug.

The importance of this has been underscored in recent years by the revelation that popular painkillers from the COX-2 inhibitor family raised risks of heart attack and stroke.

Ongoing surveillance

"A progressive, life-cycle approach to the regulation of drugs is meant to recognize that valuable information continues to grow over time, and that this information should be captured and incorporated into decision-making in a well-planned and transparent manner," said the discussion paper, dated Feb. 21 and posted on the department's website.

"For example, a new use may be discovered for a drug, and this is a potential benefit. Conversely, an interaction with another drug may be uncovered that could be a potential risk in some situations."

The former head of the Canadian Expert Drug Advisory Committee said he believes the proposal is probably "a step in the right direction.

"What I think they are proposing … is a more systematic approach to pharmaco-surveillance or post-marketing studies," said Dr. Andreas Laupacis of St. Michael's Hospital in Toronto.

"Drug companies do have to report to Health Canada around spontaneously reported events, but those are under-reported. It's not the drug companies' fault, but they just are, and there's no systematic look at this."

Success depends on regulatory powers

The discussion document said that a modern regulatory regime should "allow for the initial and ongoing collection, evaluation, and communication about drug information throughout the product life cycle," based on the latest knowledge on the risks and benefits of a drug.

While Laupacis thinks there is a need to follow drug safety in a more organized way, how effective the proposal will be depends on the powers given the regulatory agency, he said.

"What if, when you do one of these post-marketing surveillance, you find that a drug does has unexpected side-effects … Is Health Canada going to respond to that?"

Source: CBC.ca