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On April 7 at 12:37 p.m. EST, Health Canada issued a news release stating that Pfizer Canada has agreed to the department’s request to voluntarily discontinue the sale of Bextra in Canada until safety issues have been resolved. As well, the federal department is recommending new usage restrictions for Celebrex®.

With regard to Bextra™, Health Canada has asked Pfizer to submit evidence to establish the safety of this drug product under the conditions of use for which it is recommended. In addition, the manufacturer has been asked to provide Health Canada with a risk/benefit analysis indicating the product's unique therapeutic advantage. Health Canada says that this decision is based on an ongoing review of information with regard to serious, potentially life-threatening skin reactions.

Health Canada is asking the public taking Bextra to contact their physician to discuss discontinuing use and alternative treatments. And, after having consulted with a physician, consumers should return the unused product to their pharmacy.

According to the Health Canada news release, new restrictions concerning the use of Celebrex® are as follows:

· Patients who have had a heart attack or stroke, experienced serious chest pain related to heart disease, or who have had serious diseases of the heart such as congestive heart failure, should NOT use this medication.

· Patients who have significant risk factors for heart attack or stroke should be aware that using this drug may increase this risk. Risk factors for heart attack and stroke include high blood pressure (treated or untreated), high cholesterol, diabetes and smoking. In consultation with their doctors, patients with such risk factors should consider using other types of medications or pain relief therapies.

· This medication should be prescribed and used at the lowest possible dose, and for the shortest, necessary period of time.

· Selective COX-2 inhibitor NSAID's should only be used to treat the pain and inflammation of arthritis, and certain types of acute pain. These drugs may be used to treat osteoarthritis and rheumatoid arthritis. Celebrex® may be used for the short-term (one week or less) management of moderate to severe pain in adults caused by conditions such as sprains, surgery or tooth extractions. In the past, Celebrex® had been used to treat family polyposis (the presence of multiple polyps in the colon) but this indication was cancelled in December 2004 and a public advisory was issued at that time.

Health Canada urges patients using Celebrex® to talk to their physician to weigh the risks and benefits of these drugs in light of their own medical circumstances.

There is currently no information posted on Pfizer Canada’s website about the suspension of Bextra in Canada, or how pharmacies should manage the return of this product. It is expected that Pfizer will communicate directly to pharmacies about this issue shortly.

To read Health Canada's news release go to www.hc-sc.gc.ca
 

Tests find antibiotic in river: Water samples pick up traces of tetracycline, spawning fears
Jason Warick

A common antibiotic has been detected in the South Saskatchewan River, raising questions about possible effects on the ecosystem and even human health.

Pharmaceuticals of all kinds -- from cholesterol-lowering drugs to birth control hormones -- are being discovered in water bodies around the world. Although the amounts are generally small, it's unclear how much is required to cause harm.

"This was an eye-opener. This stuff is ending up in our water systems," Saskatoon researcher Brij Verma said of his work with the antibiotic tetracycline.

"Does it have an effect? I don't know yet. The point is it's there."

As part of his doctoral research, Verma took numerous water samples from the South Saskatchewan River in Saskatoon during the past 10 months.

He tested for tetracycline, given to humans to treat pneumonia, acne, and a wide range of infections. But it's also become standard practice to put large doses of this drug into livestock feed.

Tetracycline turned up in nearly all of Verma's samples taken from the river.

"People never thought of this stuff as a pollutant," he said in an interview at the National Hydrology Research Centre at Innovation Place.

These trace amounts are extremely small, measured in parts per billion with the use of a powerful mass spectrometer.

Randy Munch, the City of Saskatoon's utility services general manager, said any antibiotics would likely slip through the water treatment process intact, as they are usually in diluted form.

Pharmaceutical contamination is quickly becoming a major issue for water plant operators across North America, he said. Saskatoon chemists and water managers have exchanged several memos in recent months on the subject, and Munch said they'll follow the research closely.

"Any time you know there's contaminants in the water, that's a concern to everybody," Munch said.

"But without the science behind it, you have absolutely no idea what's there."

To this point, water testing has focused on bacteria and parasites such as E. coli and cryptosporidium. Now researchers from Europe and the U.S. are starting to examine pharmaceutical pollution of water systems.

The United States Geological Survey (USGS) found pharmaceutical contamination in 80 per cent of the 139 streams it sampled recently.

"Protecting the integrity of our water resources is one of the most essential environmental issues of the 21st century," says a USGS study.

"Potential concerns from the presence of these compounds include reproductive impairment, increased incidences of cancer, the development of antibiotic-resistant bacteria, and the increased toxicity of chemical mixtures."

It's unclear which other pharmaceuticals are present in the South Saskatchewan River or other local water bodies. Verma appears to be the first scientist to test for any pharmaceuticals in the province's, and even the country's, water.

This type of research is so new, nobody knows how much antibiotic it takes to alter the environment or to affect human health.

"This is a wide open field," Richard Robarts said. Robarts, based in Saskatoon, is Verma's supervisor and is director of a United Nations water monitoring program.

One study at the University of Wisconsin showed that extremely minute quantities of antibiotics hindered the reproductive abilities of river fleas.

The fleas are necessary to eat algae, but they are also a major food source for fish, study author Stanley Dodson said. The antibiotics have the potential to interrupt the entire food chain, he said in an interview.

"We're putting biologically active chemicals into the environment. They are active in very low concentrations. It's a very messy situation," Dodson said.

The source of the tetracycline in the South Saskatchewan River is unclear. It could occur naturally. It could be from discarded human prescriptions.

But antibiotics are most frequently used in intensive livestock operations.

The volume of antibiotics given to animals is now up to 1,000 times greater than that consumed by humans. In the United States, eight million kilograms of antibiotics are applied to animals and fruit trees each year.

According to a paper by University of Saskatchewan microbiologist George Khachatourians, the concentration of antibiotics in animal feed has increased up to 20-fold since the 1950s.

Khachatourians said Verma's findings were very interesting, although he agreed the source of the tetracycline isn't yet known.

"It says we need to take a longer look at this," he said.

Another Saskatoon research scientist will also soon be studying antibiotic presence in the water system.

Allan Cessna of the National Hydrology Research Institute received funding earlier this week to study the amount of antibiotic excreted by hogs, and how much of that ends up in the soil and water runoff.

"It is fairly new, but the raising of animals in intensive situations is relatively recent as well," Cessna said.

As for Verma, he'll expand his studies to include other antibiotics, and investigate their sources.

Alberta monitoring for health funds are restricted

Further to RxPress Now (Vol. 2, No. 14 April 11, 2002), the Alberta

Monitoring for Health Program has advised that the funds for

supplemental coverage (that patients can apply for) are not

available. Once the AMFH form is filled out and the maximum is

reached, patients will be required to pay for any additional supplies

in full.

Ontario Pharmacists Launch ‘Be MedWise‘ Campaign

Ontario Pharmacists Launch ‘Be MedWise‘ Campaign

An unprecedented survey released today reveals that Canadians are

taking over-the-counter (OTC) medicines incorrectly and do not

recognize the risks of this behaviour. Decima Research Inc.

conducted the survey of 1,171 Canadian adults who had taken a

non-prescription medication in the past six months.

About 58 per cent of adult Canadians report taking an OTC medication

in the past six months, yet many consumers are overlooking important

information that could aid them in taking OTC drugs more effectively.

The survey showed the following habit of consumers:

· 40% read the label to identify the active ingredient(s)

· 34% read the dosage level

· 26% read the symptoms it treats

· 23% read the label for possible side effects

· 18% read the directions for usage

The Be MedWise campaign has launched a new web site at

www.bemedwise.ca that provides consumers with information on how to be better informed about the medications they take.

Source:  RxPress Now, Vol. 2 No. 24