Canada

Medication pulled from U.S. shelves still in Canada

The prescription antacid cisapride, dogged by controversy in recent years, is being withdrawn from the shelves in the United States. But the drug will continue to be sold in Canada, despite worries over its safety.

In Canada, cisapride is sold under the name Prepulsid, and since 1990, has worked wonders on heartburn. But it can also cause serious side effects. Warnings have surfaced that the drug can cause heart rhythm disturbances. It's been linked to deaths in both the United States and Canada.

The U.S. Food and Drug Administration says by the end of 1999, cisapride had been associated with 80 deaths.

U.S. consumer advocate Dr. Sydney Wolfe calls it a killer drug, saying an additional 23 deaths have occurred since the beginning of the year.

The manufacturer, Janssen Pharmaceutica US, says the vast majority were due to avoidable factors, but, in a letter sent to American authorities last week, the company admitted serious side effects continue, despite efforts to promote the "safe use of the drug."

Last year, the manufacturer revised the labelling of cisapride in the U.S., where it's called Propulsid. Then in March, Janssen announced it would discontinue marketing the product in the U.S. Now it is being pulled altogether from American shelves, effective July of this year.

"Because of the risk of serious cardiac arrhythmias and death associated with the use of Propulsid in certain patients, Janssen, in consultation with the FDA, has decided to discontinue marketing Propulsid as of July 14, 2000 and make it available only through an investigational limited access program," the company announced this week.

In spite of the move in the U.S., the Canadian manufacturer hasn't taken the drug off the market. Instead, it sent two letters warning doctors of possible side effects and information on how to prevent them.

Some Canadian doctors say the drug, also used to treat stomach and bowel problems, can still be effective if used properly.

In a news release dated March, the Canadian manufacturer said cisapride "remains safe and effective" when used appropriately.

The company said it won't take the drug off the market unless Health Canada tells it to do so. The government hasn't said when a decision will be made.

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