A CAUTION ON COLD PILLS

[Guest guest]

Hi everyone!

This article was on the front page of our local newspaper today. With

flu season approaching this may be of interest to some.

Kind regards,

Trudy

http://www.edmontonjournal.com/

A caution on cold pills

Health Canada warns of possible link to strokes

Journal Staff and News Services

The Edmonton Journal

Shelves at Edmonton pharmacies are stocked with popular cold remedies

that Health Canada warns contain an ingredient linked to strokes in

young women.

Health Canada, following the U.S. Food and Drug Administration's lead,

said Monday that because of the seriousness of a stroke and the

inability to predict who is at risk, people should immediately stop

using products containing phenylpropanolamine.

The FDA said it will immediately take steps to ban the ingredient, and

it has asked

manufacturers to stop marketing the drug.

Health Canada said it has no plans at this time for a mandatory

recall. Diet products, which are not sold in Canada, had the strongest

association with hemorrhagic stroke.

Dr. Ashfaq Shuaib, chief of neurology at the University of Alberta

Hospital, says doctors

have long believed PPA was a factor in causing hemorrhagic strokes,

but until now had no studies to back them up.

University Hospital has 100 cases of hemorrhagic stroke a year and 40

of those are in people under 45 years old.

Shuaib suspects that many of these cases may have been brought on by

cold remedies.

He also strongly suspects that pseudoephrine, another drug in cold

remedies that has the same effect on blood vessels, is equally

harmful, though so far there has been not been a study to prove this.

" These are not essential ingredients anyway, " Shuaib said. " They just

give you the feeling you're better. "

PPA increases blood pressure and heart rate. It is found in at least

63 different cold and cough medications in Canadian pharmacies, Health

Canada said.

" Do I think we all need to run out and pull these things off the

shelf? No, I do not, " said Briggs, president of the Alberta

College of Pharmacists.

FDA officials estimate that six billion drug doses containing PPA are

taken every year in the U.S., about 98 percent to treat colds and

coughs. The ingredient has been marketed for more than 50 years. The

study noted that the risk of stroke was highest among those

taking higher doses of PPA -- more than 75 milligrams daily -- a

dosage commonly used by dieters taking appetite suppressants.

Briggs said most cold remedies contain only five milligrams. Only

Entax has 75 mg, but it is released slowly and doesn't jolt the

system, she said.

" We are trying to be anything but alarmist here, " said Ganley,

director of the FDA's over-the-counter drug division. " Consumers want

to know if there is a problem with a product. If we had waited several

more months to come out with it, people would have asked, 'Why didn't

you come out with it sooner?' "

The move to ban the ingredient is extraordinary because of its

immediacy and its scope, affecting millions of people, U.S. medical

experts said.

Patients with cold and cough symptoms can seek other over-the-counter

remedies -- including Sudafed, Benadryl and Drixoral.

Contac's maker, Kline Beecham Consumer Healthcare, said it will

stop making its 12-hour capsules with PPA, which comprise one-third of

the entire Contac line. " We're all over this, " said Lovre, a

spokesperson at Kline.

One of the popular drugs is Alka-Seltzer Plus, with up to 800 million

tablets sold annually. Manufacturer Bayer Co. said it will try to

reformulate the cough-cold products.

" Given the product's 30-year safety record with no reports of

hemorrhagic stroke associated with its use, the company is evaluating

current product marketing options during the transition, " the company

said in a statement.

Millions of people have taken drugs containing PPA, which the FDA said

is responsible for 200 to 500 strokes each year among people ages 18

to 49.

Women are at least 16 times more likely to have a stroke within three

days of taking an appetite suppressant with PPA compared with women

who didn't take the drug. Women are also three times more likely to

have bleeding in the brain within three days of taking

cough-cold remedies with PPA, according to research conducted by Yale

University.

Men did not show the same level of elevated risks, but the FDA

recommends that they stop taking drugs with PPA, too.

In the case of PPA, researchers have not been able to determine who is

most at risk or how many doses put people at risk of bleeding in the

brain.

The FDA notified the drug industry in the early 1990s that regulators

would remove PPA from its list of safe ingredients unless the industry

undertook a study to disprove a link between PPA and strokes.

That study, conducted by Yale, took five years to complete.

The FDA's decision came after one of its advisory panels recommended a

ban on PPA in over-the-counter products last month.