Stroke link brings warning to avoid cold remedies
November 07, 2000

Mary Vallis
National Post, with files from The Canadian Press

U.S. and Canadian health authorities are warning consumers to stay away from more than 60 different over-the-counter cough and cold remedies that contain an ingredient linked to hemorrhagic strokes, especially in young women.

The U.S. Food and Drug Administration said yesterday that it is taking steps to ban non-prescription drugs containing the decongestant phenylpropanolamine (PPA), and it further said that until the ingredient is replaced, people should not use products that include it.

The agency took the step based on a report released in mid-October that linked PPA to deadly hemorrhagic strokes, or bleeding in the brain, among a small percentage of the millions of people who take the drug each day.

Until it meets the legal requirements to ban the ingredient, which will take several months, the agency has asked manufacturers to stop selling products containing PPA immediately.

Health Canada last night said it has decided to follow the FDA's lead and advise people not to use products containing PPA.

''Given the fact that these medications provide only temporary relief, Health Canada is recommending, as a precaution, that consumers do not use any products containing PPA until a full assessment has been completed,'' a department release said.

Roslyn Tremblay, a departmental spokeswoman, said people taking prescription decongestants should check the ingredients with their doctors or pharmacists.

The FDA says PPA could be the cause of deadly hemorrhagic strokes in 200 to 500 people under age 50 -- people who are typically considered too young to be at risk for stroke -- every year.

Products containing the ingredient are already disappearing from stores in Canada.

SmithKline Beecham Consumer Healthcare asked retailers in Canada and the United States to remove all of its products containing PPA from store shelves.

Kevin Foley, a spokesman for the company, stressed that the type of products containing PPA differs in Canada and the United States. In Canada, the company's list includes Sine-Off, all Ornade and some -- but not all -- Contac products.

Canadian consumers have access to nasal decongestants and cough-and-cold remedies that are PPA-free.

In the U.S., PPA in larger doses is also found in over-the-counter diet products. In the 1980s, medical journals cited several cases of young women suddenly suffering hemorrhagic strokes within days of taking appetite suppressants.

Dexatrim, an appetite suppressant sold on both sides of the border, was named by the FDA as one product in question, but the Canadian formulation does not contain PPA.

Popular cold remedy recalled in wake of FDA warning

Nov. 6, 2000
Health Canada has followed the lead of the US Food and Drug Administration is issuing a warning about an ingredient in dozens of cold remedies. Phenylpropanolamine - or PPA - has been linked to hemorrhagic strokes, especially in women under the age of 50.

The ingredient is found in products ranging from Triaminic to Dexatrim. However, Health Canada says PPA is not used in appetite suppressing drugs in Canada.

Cold Remedies Sold in Canada containing PPA

ALKA-SELTZER PLUS COLD MEDICINE
EVT ANTITUSSIVE DECONG ANTIHISTAMINE SYR
BRONCHODEX D CAP
CALDOMINE DH ADULTE
CALDOMINE DH ENFANT
COLD & ALLERGY RELIEF - LIQ
COLD DECONGESTANT LONG ACTING CAP
COLD RELIEF
COLD RELIEF DM
COLTALIN TABLET
CONTAC COLD CAPSULES
CONTAC COLD EXTRA STRENGTH CAPSULES
CONTAC COUGH COLD AND FLU CAPLETS
CORICIDIN D LONG ACTING TAB
CORICIDIN D TAB
CORICIDIN ND TAB
CORICIDIN SINUS HEADACHE TAB
COUGH, COLD & ALLERGY RELIEF
COUNTERACT SINUS AND ALLERGY
DECONGESTANT ANTIHISTAMINIC SYRUP
DILOTAB
DIMETANE EXPECTORANT LIQ
DIMETANE EXPECTORANT-C SYR
DIMETANE EXPECTORANT-DC SYR
DIMETAPP CHEWABLE TABLETS
DIMETAPP CHILDREN'S COLD & ALLERGY TABLETS
DIMETAPP CHILDREN'S COLD & FEVER
DIMETAPP CLEAR
DIMETAPP COLD & SINUS
DIMETAPP COUGH & COLD LIQUI-GELS - CAP
DIMETAPP COUGH, COLD & FLU
DIMETAPP DM ELIXIR
DIMETAPP DM TAB
DIMETAPP ELIXIR
DIMETAPP EXTENTABS
DIMETAPP LIQUI-GELS CAP
DIMETAPP ORAL INFANT DROPS
DIMETAPP TAB DIMETAPP-C SYR
EMERCIDIN "D" TAB
ENTEX LA ORADRINE 2 TAB
ORADRINE TABLETS
ORNADE AF SPANSULE SRC
ORNADE SPANSULE SRC
PHARMACOL DM SYR
SINE OFF ND EXTRA STRENGTH CAPLET
SINE-OFF ALLERGY TAB
SINE-OFF N.D. TABLET
SINUTAB SA TAB
TANTACOL DM SYR
TANTAPP ELIXIR
TAVIST-D TABLETS
TRIAMINIC COLD AND ALLERGY SYRUP
TRIAMINIC DM DAYTIME SYR
TRIAMINIC EXPECTORANT DH SYRUP
TRI-ANAMINE COLD SYRUP
TRI-ANAMINE EXPECT ANTIHIST DECONG SYRUP
TRISULFAMINIC SUS
TRISULFAMINIC TAB
TUSSAMINIC C FORTE SYRUP
TUSSAMINIC DH FORTE SYRUP
TUSSAMINIC DH PEDIATRIC SYRUP

Health Canada says there has been only one reported case of a stroke in Canada related to P-P-A in the past two decades. SmithKline Beecham is urging consumers to call a hot line -- 1-888-366-7475 -- if they're confused about the risk.

Health Canada says if you're unsure whether PPA is in your cold medicine, check the list of active ingredients. If you are still not sure, check with your pharmacist.

Let me play the devil's advocate here. Is it right for Health Canada to just do what the FDA does? I mean, everyone knows there are lots of politics and US manufacturers interest in what the FDA does, and it is NOT always based on individual's health. So why follow them blindly?

Wa'ii

Actually, Canadian officials were not planning to follow suit. They only caved in to PUBLIC pressure, after the news was released in the U.S. The company that makes Contac-C pulled its products of the shelf voluntarily here in Canada first. This risk of brain hemorrhage (very, very tiny risk) is not new; the american FDA has been toying with the idea of introducing a total ban for weeks. If it's such a big worry today, why wasn't it a big panic then??

Canada doesn't always follow in the shadow of Uncle Sam. That's why we could buy Splenda for nearly a decade before the states, that's why we can still buy cyclamates (SugarTwin) here and not in the states.

Doreen



Canadian doctors skeptical about U.S. drug warning
WebPosted Fri Oct 20 06:41:36 2000

TORONTO - Canadian doctors are not convinced that a common diet and cold medication is a common cause of hemorrhagic strokes, despite a warning from U.S. researchers.

Scientific advisers to the U.S. Food and Drug Administration ruled 13-0 Thursday that phenylpropanolamine, also known as PPA, can cause bleeding in the brain in some people under 50.
The drug is included in many over-the-counter products, from Dexatrim to Triaminic.

Manufacturers maintain that PPA is safe, arguing there is no proof it causes hemorrhagic strokes.

The FDA is not bound by the recommendations of its advisory panel, but usually follows them. It is considering a ban on PPA.

In Canada, meanwhile, physicians contacted by the CBC said they don't know of any hemorrhagic strokes caused directly by phenylpropanolamine.

CBC TV's medical correspondent, Dr. Brian Goldman, said Canadian doctors think there are probably other factors behind such bleeding – ranging from ignoring proper dosage warnings to taking cocaine or other drugs.

O.k. I stand corrected, but they both have "similar" oddities. US endorses Aspartame as sweetner, Canada endorses Sucralose, by endorse, I mean they allow the "sweetner" labels. Yet both, refuse to allow Stevia distributors, to call it sweetner. This is a natural plant extract, and sweeter than all the other chemical junk, yet you'll have to look hard for it, and figure out what the product does, since the distributor is not allowed to call this sweet plant a "sweetner".

Wa'il