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Published: Thursday, 11/30/2000

A risk too great

If the Food and Drug Administration can be faulted for acting to remove a harmful over-the-counter drug from the market, it may be on the grounds that it should have acted sooner.

Concerns about the safety of phenylpropanolamine - a chemical in cough and cold remedies and in appetite suppressants - are not new. It was during the 1980s that reports surfaced about people who suffered hemorrhagic stroke after consuming products containing PPA. Hearings about the ingredient prompted a study.

The research was conducted by Yale University, which was paid $5 million by the Consumer Healthcare Products Association to do the study. Oddly, the association rejected the study results because it considered the findings to be unsound.

Fortunately, the FDA disregarded the trade group's hesitation and warned consumers to stop using products with PPA, which the government believes is linked to as many as 500 strokes a year. The FDA plans to completely ban the chemical - which would cover prescription drugs, too - a process that could take months.

Meanwhile, the New England Journal of Medicine has released a study on another ingredient, ephedra, which also has been linked to strokes and to seizures. That ingredient is in products that the FDA does not regulate, such as natural appetite suppressants. Among 140 people who reported serious side effects from taking products with ephedra, 13 per cent were disabled. Ten died. Those statistics should not be ignored.

Although it will be a while before products with PPA are no longer available, drug stores and supermarkets are helping by pulling products with PPA from their shelves. Some makers of the drug say they won't manufacture any more. Those moves are in the public's best interest.



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