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

Germany recalls locally made blood thinner heparin; Canadian products differ

From the Canadian Press:
Germany's medical authority said Friday it has recalled a locally produced version of the blood thinner heparin believed to be linked to contaminated ingredients from China after 80 patients suffered adverse reactions.

Axel Thiele, a spokesman for the Federal Institute for Drugs and Medical Devices, said the drug, produced by RotexMedica GmbH, was pulled from the market after 80 patients suffered shortness of breath, low blood pressure and episodes of rapid heartbeat.

No one taking the drug in Germany has died, he said, and no other drug companies' products are involved.

A different brand of heparin produced in the United States has been linked to 19 deaths there, the U.S. Food and Drug Administration has reported.

On Friday, Health Canada said the U.S. deaths are associated with injectable heparin sodium made by Baxter International Inc., and these products are not sold in Canada. ...more

Pain pill may go over the counter

As a pharmacist and as a patient, I'm thrilled about the prospect of OTC naproxen. My view is that it is no more dangerous than ibuprofen, which has been over the counter for years. It's analgesic effect and longer duration of action seals the deal for me.

It is curious that Health Canada has decided to address this now. Did someone request that the regulatory body re-evaluate the status of naproxen? With the long list of drugs already waiting for approval, it seems unlikely they decided to create a "make work" project for themselves.

From the National Post:
Health Canada is proposing to let a form of Naproxen be sold without a prescription for the first time, which would make the popular drug easily the most powerful painkiller available over the counter.

Some experts are questioning the change, though, noting that it comes as scientists shine increasing light on such "NSAID" medications and the risks they pose. Non-steroidal anti-inflammatory drugs can cause ulcers and other stomach problems, may increase the risk of heart attacks and, one recent study suggests, seem to boost the danger of birth defects if taken by pregnant women.

"It's strange that we would be doing it now," said Dr. Pat Morley-Forster, head of the University of Western Ontario's multi-disciplinary pain centre. "I think it's a bad move."

Other specialists say the medicine is already available over the counter in the United States, and many Canadians bring shipments of it back across the border. They also note that Naproxen appears to be safer for the heart than other NSAIDs, such as Celebrex and Ibuprofen, which is sold in Canada without a prescription. ...more

Review Determines Measles, Mumps and Rubella Vaccine Lots Can be Released for Use

From Health Canada:
Health Canada has recently completed its review of Merck Frosst’s reports pertaining to a lot (1529U) of measles, mumps and rubella (MMR) vaccine potentially associated with six cases of suspected anaphylaxis in young adults in Alberta during November and December 2007. The review found no link between this vaccine lot and the adverse events in Alberta.

Based on this information, the suspension of this lot (1529U) and two other associated lots (1528U and 1680U) have been lifted and are available for use by provinces and territories to vaccinate both adults and children requiring MMR immunization. Health Canada had asked provincial and territorial health authorities and all other Canadian vaccine providers on December 11, 2007 not to use these lots of the MMR-II vaccine sold by Merck Frosst Canada. At that time, Health Canada requested that Merck Frosst Canada provide a written report on any manufacturing or safety problems associated with Lot 1529U and its bulk components to complement other ongoing investigative efforts. ...more

Health Canada says no evidence of cardiac risk from Nexium, not clear for Losec

From the Canadian Press:
Health Canada says it finds no evidence to suggest a popular heartburn drug increases the risk of cardiac problems.

The department says it will continue to monitor safety data for Nexium (esomeprazole) as it is produced, but at this point does not see a link between the drug and cardiovascular risks.

But the department says the picture is less clear for another heartburn drug, Losec (omeprazole).

It says after a thorough analysis, Health Canada cannot definitively say if there is a potential for increased cardiovascular risk in people taking the drug on a long-term basis. ...more

Hospitals may have to report bad drug reactions

From the National Post:
Hundreds of hospitals across the country would be forced to inform federal authorities whenever patients had serious reactions to drugs and medical devices under a controversial plan Health Canada is quietly proposing.

The regulator notes that as many as 45,000 hospital patients a year suffer from sometimes fatal side effects to the treatments meant to help them, yet only 2% of the incidents are reported.

The tentative proposal is already meeting resistance, though, with critics arguing that making reporting mandatory is a "quick fix" that by itself will not generate the desired flow of safety information.

"Simply passing a law that says, 'It's mandatory' I don't think is going to remove the barriers that are there to improved reporting," said Jeff Poston of the Canadian Pharmacists Association, whose members produce most ad-verse-reaction reports currently. "I don't think it's really a solution." ...more

New drug rules pose grave risks: critics

From the Globe and Mail:
The federal government is about to overhaul the way drugs are regulated in Canada to give consumers faster access to breakthrough treatments, but some medical experts and political critics are worried the changes will turn Canadians into guinea pigs for new drugs that haven't been adequately tested.

A new regulatory system, outlined in a broad package of changes to consumer product and food regulations announced last December, would allow certain drugs to be quickly approved for sale without the safety evidence that is normally required.

The changes are designed to update Canada's aging drug regulation system to allow faster access to new blockbuster pharmaceuticals and let health officials evaluate potential risks throughout a drug's lifespan, instead of focusing on safety mainly before they're approved.

But without massive changes in the way health officials monitor drugs once they hit the market, the new system could pose serious risks to consumers, said David Juurlink, clinical pharmacologist and drug safety researcher at Toronto's Sunnybrook Health Sciences Centre. ...more

Health Canada investigates Botox

From CBC News:
Health Canada is reviewing safety information on the wrinkle treatment Botox, just days after a call from a U.S. lobby group to increase the warnings on the drug.

Last week, Dr. Sidney Wolfe of Public Citizen Health Research Group said severe reactions including deaths have been linked to Botox.

Botox uses botulinum toxin, which blocks nerve impulses to muscles, causing them to relax. But in a few cases, the toxin has spread to other parts of the body, resulting in problems including paralysis of respiratory muscles and difficulty swallowing, potentially leading to food or liquids entering the lungs and causing aspiration pneumonia, Wolfe said.

Botox is traditionally used as a cosmetic treatment to ease facial wrinkles, but is also used for treating spasticity and tense muscles. ...more

Health Canada reviewing safety of Botox

From CTV News:
Health Canada says it's reviewing safety information about the popular wrinkle treatment Botox and a similar product, Myobloc, following reports out of the United States about side effects and deaths.

The U.S. consumer advocacy group Public Citizen is asking the U.S. Food and Drug Administration to require Allergan Inc. to write to doctors warning them that their product Botox and other botulinum toxins marketed in the United States have resulted in "hospitalizations and deaths."

It also wants the FDA to order that Botox and Solstice Neurosciences Inc's Myobloc carry the strongest possible warning, highlighted in a "black box."

Public Citizen said it has reviewed 180 reports submitted to the FDA by manufacturers since the late 1990s involving patients injected with Botox or Myobloc. The reports detailed cases of muscle weakness, difficulty swallowing or aspiration pneumonia -- a serious condition caused by breathing a foreign material into the lungs. ...more

Health Canada defends drug alert system

From CBC News:
Despite evidence indicating seniors are being prescribed potentially dangerous drugs, Health Canada says it can't do anything more to make its warnings about these medications more effective.

The department is responding to a CBC News investigation in December revealing that doctors continue to prescribe anti-psychotic drugs to seniors, despite Health Canada warnings in 2005 that the drugs increased the risk of heart attack, stroke and death.

CBC analyzed sales data for the drugs and found that prescriptions increased from seven to 40 per cent for a 24-month period after the warnings. ...more

Dangerous drugs continue to be prescribed to seniors: CBC report

From CBC News:
Doctors are continuing to prescribe drugs dangerous to seniors in spite of government warnings, a CBC News investigation reveals.

More than two years ago, CBC News first reported that more than a million seniors were prescribed atypical antipsychotics. Atypical antipsychotics are specific kinds of antipsychotic drugs. They are considered by many experts to be ineffective or even dangerous for elderly patients.

Health Canada followed up with warnings pointing to the drugs' side effects — including a 60 per cent greater risk of death in seniors who were taking the drugs than in patients taking placebos — gleaned from 13 scientific studies. It also warned that elderly patients taking atypical antipsychotics were almost twice as likely to die from side effects such as heart failure. ...more

Don't use cold medicines in children under 6: U.S. government advisers

From CBC News:
Cold and cough medicines don't work in children and shouldn't be used in those younger than six, U.S. federal health advisers recommended Friday.

The over-the-counter medicines should be studied further, even after decades in which children have received billions of doses a year, the outside experts told the Food and Drug Administration.

The FDA isn't required to follow the advice of its panels of outside experts but does so most of the time.

"The data that we have now is they don't seem to work," said Sean Hennessy, a University of Pennsylvania epidemiologist, one of the FDA experts gathered to examine the medicines sold to treat common cold symptoms. The recommendation applies to medicines containing one or more of the following ingredients: decongestants, expectorants, antihistamines and antitussives. ...more

Drug makers pull cold remedies aimed at toddlers

From the Globe and Mail:
Drug makers voluntarily pulled a range of cold medicines aimed at children under the age of two off the market in the United States on Thursday, and at least two Canadian companies have followed suit.

In tandem, Health Canada issued a statement Thursday with recommendations for the appropriate use of non-prescription cough and cold products in children.

“Life-threatening adverse events, including unintentional overdose, have been reported to Health Canada in association with the use of these products in children under two years of age,” the statement said. ...more

Health Canada to advise against cough, cold remedies for infants

From CBC News:
Health Canada is expected to issue an advisory warning people not to give over-the-counter cold and cough medications to children under two and adjust labels to reflect the concerns, CBC News has learned.

The warning, which will come within days, follows an American study that says the medications have a questionable benefit and, in some cases, could be dangerous.

Earlier this year, the U.S. Food and Drug Administration completed an internal review of serious and life-threatening effects and deaths in young children dating back to 1969. ...more

Health Canada pulls market approval for drug Prexige, citing liver problems

From the Canadian Press:
Health Canada has ordered the anti-inflammatory drug Prexige off the market, citing the potential for severe liver-related side-effects.

The department said it was stopping sales and would cancel market authorization for lumiracoxib, which is sold as Prexige by Novartis Pharmaceuticals Canada Inc.

People taking the drug are being instructed to talk with their doctors about finding an alternate pain relief therapy.

"Given the availability of alternative treatment not known to present a similar level of risk, Health Canada decided that the safest option was to withdraw the drug from the market," department spokesperson Alastair Sinclair said in e-mailed responses to questions. ...more

Health Canada orders Parkinson drug off market

From CTV News:
Health Canada is ordering a drug used for treatment of Parkinson's disease off the market.

The department has told maker Eli Lilly that sales of the drug Permax (pergolide mesylate) must cease as of Aug. 30. Studies have shown the drug can cause serious heart valve damage in some users.

Eli Lilly voluntarily withdrew the drug from the U.S. market in late March after studies in the New England Journal of Medicine underscored the valve problem risk.

Health Canada says there are alternatives to Permax available to people with Parkinson's disease. ..more

Rules set to loosen for issuing narcotics

The proposed legislation in this article could potentially allow a wide range of health professionals to prescribe controlled drugs. This list could include pharmacists.

For example, in Alberta, the new pharmacist prescribing rules prohibit controlled drug precribing because it's federally regulated. However, these changes would allow a profession to go Health Canada, prove it has the necessary training and then Health Canada would sign off on the profession in a general sense. Then the individual provinces would have to decide whether they would allow narcotics to be included in the scope of other pharmacist prescribing.

Not being able to prescribe these drugs was never a dealbreaker for Alberta pharmacists when it came to pharmacist prescribing, so it may not be necessary to do right away, but it does at least open that door.

From the National Post:
Foot doctors, midwives and nurses would be able to prescribe morphine, Oxycontin and other powerfully addictive medicine under a proposed federal rule that some analysts fear could inadvertently fuel Canada's growing prescription drug-abuse problem.

Health professionals who stand to benefit from a loosening of the decades-old restrictions on "controlled substances" applauded the move. It should mean better service for patients and less strain on the overworked physicians who must prescribe the medications now, they said.

One drug-abuse expert, though, warns that the monitoring and control of opiates is already inadequate, so allowing additional professionals to approve them would shift more pills into the burgeoning black market.

It probably makes sense to give the three groups such prescribing authority, said Dr. Benedikt Fischer of the Centre for Addictions Research of B.C.

However, with Canada using five times as many opiates per capita as the U.K., we need tighter limits generally on the distribution of narcotics, he said. ...more

Counterfeit toothpaste potentially more harmful than suspected: Health Canada

From the Edmonton Sun:
Health Canada warns consumers that ongoing tests on counterfeit toothpaste have resulted in preliminary evidence of a more harmful bacterial contamination than first suspected.
The report follows a June 29 warning in which the agency said that counterfeit toothpaste products, labelled as Colgate Fluoride Toothpaste Herbal and Colgate Fluoride Toothpaste Maximum Cavity Protection, contained high levels of harmful bacteria.

The agency warns in a new release issued today that if confirmed through further testing, the presence of this bacterium could pose a serious health risk.

Health Canada advises all those who have the phoney toothpaste to immediately stop using it and keep it out of the reach of children. ...more

Health Canada: Keep medical pot consumption low

From CTV News:
Health Canada has been contacting doctors who prescribe medical marijuana for their government-approved patients, advising them to keep the dosages low.

Some users say that not only violates doctor-patient confidentiality, it's also wrong for bureaucrats to make judgments about the medical needs of people they've never seen.

"A person's medication should be between him and his doctor,'' said Tony Adams, 60, a medical marijuana user in Victoria.

"There shouldn't be some bureaucrat in Ottawa that's never met me. Everybody has different needs for medications.''

Adams, a licenced user who's been smoking seven grams of marijuana daily, recently applied to Health Canada to increase the dose to 10 grams, with his doctor's authorization. Official approval from Ottawa is needed so that Adam can legally grow the appropriate number of marijuana plants, set by Health Canada at five plants for each daily gram.

But a program official in Ottawa challenged Adams' doctor in a telephone call, saying most patients need no more than five grams. Adams, who has severe arthritis and degenerative disc disease, later received a new licence for just five grams a day. ...more

Health Canada faces huge backlog in the licensing of natural health products

From the Toronto Star:
An estimated 20 per cent of Canadians regularly use natural remedies because they believe they are safer than man-made pharmaceuticals, according to David Bailey, a clinical pharmacologist at the University of Western Ontario.

"That is simply not true," he says. "Many of our most potent medications and toxic substances are derived from plants."

Health Canada tries to keep up with new products through its Natural Health Products Directorate. Products that meet the agency's criteria for safety, efficacy and quality get a licence and an eight-digit Natural Product Number. All 50,000 natural health products for sale in Canada must have an NPN by 2010. ...more