Health Canada, FDA warn of swine flu scams

From the National Post:
Health authorities in Canada and the United States are on high alert for Internet scams related to swine flu and are cracking down on websites that are selling unauthorized products and making illegal claims about how to prevent and treat the illness.

Health Canada and the U.S. Food and Drug Administration are tracking the websites and have issued dozens of warning letters to force the removal of offensive claims.

Among the products that have popped up online are: a pill that is purported to cure a swine-flu infection within hours; a spray that claimed to leave a layer of ionic silver on the skin that would kill the virus; fake test kits; a shampoo; nasal sprays; wall-mounted ultraviolet light machines that allegedly prevent the spread and destroy the virus; and an electronic instrument that declared its "photobionic energy" and "deeply penetrating mega-frequency life-force energy waves"would strengthen the immune system and prevent infection. The machine costs thousands of dollars. ...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

Health Canada weighs options as U.S. FDA adds "black box" warnings

From the Ottawa Citizen:
Health Canada is still in discussions with Pfizer Inc., about whether to add safety warnings to packages containing anti-smoking drugs that may have psychiatric side effects, including suicidal thoughts.

South of the border, U.S. health officials Wednesday ordered Pfizer Inc and GlaxoSmithKline PLC to add strong "black box" warnings on their anti-smoking drugs to highlight the risk of serious mental health problems.

Philippe Laroche, spokesman for Health Canada, said the federal agency expect to reach an agreement with the pharmaceutical giant by the end of this summer, or the fall.

"In addition to updated safety information regarding the risk of psychiatric events, new labelling will also incorporate information regarding angioedema, serious skin reactions and accidental injury," said Laroche in an email to Canwest News Service.

The U.S. warnings, which must be added to Pfizer's Champix and Glaxo's Zyban, follow more than five thousand reports of depression, hostility and other behavioural changes in the U.S., the Food and Drug Administration said. ...more

Health Canada puts foot down on electronic cigarettes

From CBC News:
Health Canada is warning people not to use so-called "electronic smoking" products, and has instructed businesses not to promote or sell them until the government has evaluated their safety.

"Persons importing, advertising or selling electronic cigarette products in Canada must stop doing so immediately," Health Canada said in a statement Friday.

This includes electronic cigarettes (dubbed "e-cigarettes"), cigars, cigarillos and pipes, and cartridges of nicotine solutions.

The department said sales, imports and ads for the devices, which vaporize tobacco without burning it, are governed by the Food and Drugs Act and require federal approval, which none has so far received. ...more

Health Canada asks for quarantine of drugs from Indian plant under investigation

From the Canadian Press:
An Indian pharmaceutical firm has agreed to a Health Canada request to quarantine all drugs coming into Canada from a manufacturing plant alleged to have falsified data and test results.

Health Canada said Thursday that Ranbaxy Canada has agreed to place a hold on all drugs coming into the country from the Paonta Sahib manufacturing facility.

Health Canada revealed the move in a brief end-of-day email in response to questioning from The Canadian Press.

The questions were provoked by a statement issued Wednesday by the U.S. Food and Drug Administration. The FDA said it was halting review of new drug applications involving the Paonta Sahib plant because it had evidence of data falsification.

Health Canada provided no details of how many or what type of drugs Ranbaxy Canada imports to this country. Nor did it offer advice to people who might be taking those drugs.

"Health Canada is taking appropriate actions to mitigate the potential risks to the health and safety of Canadians," said the response, sent by spokesperson Alastair Sinclair.

"Following Health Canada's request, Ranbaxy Canada has quarantined all products imported into Canada from the Paonta Sahib site." ...more

Rare brain infection linked to MS drug

From CBC News:
There are reports of a rare brain infection among people taking the multiple sclerosis drug Tysabri, Health Canada warns.

The brain infection, called progressive multifocal leukoencephalopathy, or PML, usually happens in people with weakened immune systems.

Since Tysabri first came on markets several years ago, five people around the world who were taking the drug developed PML and one case resulted in death, Health Canada said Wednesday.

The drug has been approved for use in Canada since 2006 for the treatment of the relapsing-remitting form of MS, a progressive neurodegenerative disease.

In this type of MS, patients alternate between periods when they experience symptoms and when they don't. ...more

Drug for sale despite Health Canada warning

From CBC News:
A drug currently available in some Canadian stores — said to induce the same kind of "high" as the street drug ecstasy — may pose serious health risks, Health Canada says.

Nevertheless, the department says, it has seen a steady increase in shipments of the drugs to the country — which are manufactured in the United States by Stargate International and sold and distributed by Purepillz, a Canadian retailer.

Four products — Peaq, Freq, PureRush and PureSpun — are promoted on the Purepillz website as "social tonics," Health Canada said.

The pills, which contain some of the same amphetamines found in ecstasy, induce "kind of like a body high — nice and mellow," said Carry Dobson, of Calgary. "Your sensation of touch is heightened. So, you know, it feels pretty good."

However, the pills can "lead to dehydration, increased blood pressure, possibly seizures," warned Dr. Wende Wood of the Centre for Addiction and Mental Health in Toronto.

In July, Health Canada issued this warning: "Health Canada advises Canadians not to purchase these products from the Internet or any other source" and "is taking enforcement action" to make sure the companies stop selling them. ...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

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

Health Canada says children under 6 shouldn't get cough and cold medication

From the Canadian Press:
Children under six years old shouldn't be treated with over-the-counter cough and cold medications because the potential risks outweigh any possible benefits, Health Canada says.

The warning follows a recently completed review of scientific data on the products by the federal department, which recommended in October 2007 that children under two shouldn't be given the cough and cold remedies.

"The current decision expands on those preliminary recommendations," Dr. Marc Berthiaume, director of Health Canada's marketed pharmaceuticals and medical devices bureau at Health Canada, said Thursday from Ottawa.

The review, which included advice from an expert scientific advisory panel, concluded "there is limited evidence supporting the effectiveness of these products in children," the agency said.

"In addition, reports of misuse, overdose and rare side-effects have raised concerns about the use of these medicines in children under six. The rare but serious potential side-effects include convulsions, increased heart rate, decreased level of consciousness, abnormal heart rhythms and hallucinations." ...more

Health Canada probes 5 deaths that followed Botox injections

From the Victoria (BC) Times Colonist:
Health Canada is investigating the deaths of five people who had been injected with Botox, and serious reactions in another eight cases.

All the deaths involved people who were treated for such medical conditions as neck and muscle spasms. Two occurred in children with cerebral palsy, including a nine-year-old boy given Botox for drooling - a condition for which the drug hasn't been approved.

The reactions suggest the botulinum toxin may have spread to other parts of the body beyond where it was injected, according to Health Canada.

Only one of the 13 reports Health Canada had received as of March 28 involved using Botox for wrinkles, and none was medically confirmed as "distant toxin spread," according to the agency's most recent adverse reaction newsletter. ...more

Cold medication not for kids under 4, U.S. companies say

From Canada.com:
As drug companies in the United States put new warning labels on cold and flu medication for children under four years old, a Canadian manufacturer of children's medicine, said it would not follow suit.

Major U.S. pharmaceutical companies announced Tuesday they would change labels on cough and cold medicines to warn consumers not to give the products to children under four, said the Consumer Healthcare Products Association, a group representing the American producers of over-the-counter kids medicine.

"After consulting with the Food and Drug Administration, the leading manufacturers of these medicines are voluntarily transitioning the labelling on oral (over-the-counter) pediatric cough and cold medicines to state "do not use" in children under four years of age," it said in a statement.

However, Johnson & Johnson Canada said no such warnings will be put on the Canadian products yet.

"At this time the initiatives in the U.S. don't affect our products in Canada," said spokeswoman Tina Peyregatt. "We have been in continuous talks with Health Canada on the same topic but at this time we have not arrived at a decision." ...more

India's Ranbaxy hit by reports of Canada drug review

From AFP:
Shares of Indian generics giant Ranbaxy hit an 18-month low Tuesday on reports Canada was looking into the safety of the firm's drugs as well as on fears about its revenue outlook, analysts said.

Ranbaxy shares have been under pressure since the US Food and Drug Administration blocked imports of over 30 of the New Delhi-based company's drugs last week, saying they failed to meet manufacturing standards.

On Tuesday, India's business daily Mint quoted the Canadian health ministry as saying a "regulatory letter" was sent to Ranbaxy Pharmaceuticals Canada requesting an action plan and a response to the FDA's move.

The company, which is being bought by Japan's Daiichi Sankyo in a deal valued at up to 4.6 billion dollars, closed down 11.05 percent or 38.35 rupees at 308.85 rupees, its lowest level since March 2007.

"We're not responding to any media reports," said a spokesman for Ranbaxy when asked about the Canadian letter. ...more

Health Canada draws blank on tainted herbal sleep medicine

From Canada.com:
Health Canada does not know how powerful prescription tranquilizers ended up in herbal sleep-aid products, and on Canadian shelves.

Nearly two years after 55-year-old Michael Berggren died in a single-vehicle rollover after unwittingly taking prescription estazolam in a herbal sleep medicine, the government has learned little about who tainted the herbal remedies, where they did it, or how.

"While some of the raw materials in four of the products were imported by the same supplier, Health Canada cannot confirm at which point in the manufacturing process the products became adulterated with this controlled substance," spokesman Alastair Sinclair wrote in an e-mail to the Edmonton Journal.

"These products may have been imported into Canada or they may have been manufactured in Canada with imported raw materials."

Sinclair did not say what the government has done to identify the source of the illegal drugs, nor what inspectors have done to figure out who is adding them to herbal remedies. ...more

Health Canada asking makers of some antibiotics to put tendon warning on label

From the Canadian Press:
Health Canada announced Thursday that it will ask makers of a class of antibiotics to include a prominent warning on the label that the drugs can lead to tendon ruptures.

The announcement follows on the heels of a similar policy decision from the U.S. Food and Drug Administration. That agency revealed Tuesday that it was asking manufacturers of fluoroquinolone drugs to put a "black box" warning - the FDA's most stringent safety labelling requirement - on their products.

In an emailed response to questions posed Tuesday, Health Canada said it will ask manufacturers of fluoroquinolones to include a "box warning" on the product monographs alerting people who take the drugs of the fact they may be at higher risk of tendon ruptures.

Drugs in the fluoroquinolone class include ciprofloxacin (Cipro), levofloxacin, norfloxacin, ofloxacin, gemifloxacin and moxifloxacin. ..more

Children's suicide attempts raise concerns about ADHD medication

From the Globe and Mail:
New questions are being raised about the safety of a drug used to treat attention-deficit hyperactivity disorder amid reports that more than 40 Canadian children have attempted suicide after taking it.

The issue highlights a long-brewing debate over the decision to prescribe powerful drugs to treat complex psychiatric problems among children.

"It does raise some concerns," said Roger McIntyre, head of the Mood Disorders Psychopharmacology Unit at Toronto's University Health Network.

"Childhood psychiatric disorders, I think, are an area [that] in and of itself remain a controversial topic."

Health Canada said it received 189 reports of adverse reactions associated with atomoxetine, sold under the name Strattera, from the time it was put on the market in February, 2005, to the end of last year.

The reports included 55 suicide attempts - 41 of which were among children aged 6 to 17, and 12 that were adults between 18 and 45. Ages were unavailable in two reports, according to information published by Health Canada in its quarterly publication on adverse drug reactions. ...more

HIV drug linked to serious liver side-effects, Health Canada warns

From the Canadian Press:
Health Canada and pharmaceutical company Janssen-Ortho are warning people taking the HIV drug Prezista that the drug can cause serious liver side-effects.

Prezista, which is used in combination with another antiretroviral medication known as ritonavir, is used to treat adult patients in whom other HIV therapy has failed.

The warning says that in clinical trials, 0.5 per cent of people who took the drug developed hepatitis or inflammation of the liver.

And since the drug has been brought to market, there have been 13 reports of patients who developed hepatitis, including two who died.

The warnings says that between mid-2006 and the end of 2007 there were also 25 reports of patients who developed other liver problems; 14 of those patients died. ...more

Canada lags on labelling drugs to warn of C. difficile

From the Hamilton Spectator:
Health Canada has not followed the lead of the U.S. by updating its warnings on certain drugs that increase the risk of contracting C. difficile.

This despite the critical connection between C. difficile and antibiotics.

American drug regulators updated a number of warnings as a result of reports from some Canadian and U.S. cities that specific strains of C. difficile were causing more severe disease than had been seen previously, said a spokesperson with the U.S. Food and Drug Administration.

The FDA started seeing post-marketing reports of C. difficile-associated diarrhea with deaths or other serious consequences, such as colectomy, the surgical removal of part of the colon.

The use of antibiotics is a major issue with C. diff because patients who have been treated with specific antibiotics are at greatest risk of contracting the disease. ...more

Company kept heparin on market during tests

From the Globe and Mail:
A drug company continued to market its heparin products in Canada even though it knew its supplier was implicated in a growing scandal involving tainted ingredients that have been linked to 19 deaths and hundreds of illnesses in the United States.

B. Braun Medical Inc. announced a recall of its heparin products in Canada, the United States and Australia last Friday, after tests confirmed some products were contaminated with an ingredient also found in heparin products recalled a month ago by Baxter International Inc., which is now the subject of a major U.S. investigation.

Baxter purchased the contaminated ingredients from Scientific Protein Laboratories LLC, a Wisconsin-based company that has a factory in China. B. Braun Medical also buys its heparin ingredients from SPL, but didn't issue a recall until tests confirmed the contamination, weeks after the supplier's ingredients were first called into question. ...more