The PPA Blues

I must admit that when the news broke last week that over-the-counter medications I've been taking since childhood could kill me, I approached the story more as a consumer than as a doctor or journalist. What do you do when an FDA advisory committee of scientists recommends the ban of an ingredient contained in hundreds of popular decongestants and appetite suppressants, citing new evidence linking it to hemorrhagic strokes caused by bleeding in the brain?

Phenylpropanolamine, or PPA, is in the headlines today, but this isn't the first time scientists have questioned its safety. The drug has been around for 50 years and has spent almost half that time mired in controversy. Since the 1980s there have been reports linking PPA to increased risk of stroke. It was to head off a possible ban that the manufacturers' trade association put up $5 million to study the risks.

This study, led by scientists at Yale Medical School, tracked more than 700 people ages 18 to 49 who had suffered a hemorrhagic stroke. It found that stroke patients were 50% more likely than control subjects to have used PPA within three days of the stroke. Even scarier, the risk among young women can be 15 times greater.

So does this mean the bottles and capsules sitting in your cabinets are poisons waiting to kill you? Not exactly. "The risk should be appreciated but not exaggerated," warns Robert DeLap, head of the FDA office that reviews over-the-counter drugs before they're marketed. "You must remember that the risk of hemorrhagic stroke in this population, even with these medications, remains very, very low."

That being said, the risk is real; the FDA estimates between 200 and 500 strokes each year could be prevented in the U.S. if the PPA in these products was replaced with something less risky.

So what can you do? The simple solution is to switch to over-the-counter decongestants and cough syrups that don't contain PPA. Finding out which ones do and which don't is as easy as reading the ingredients on the label. Finding alternative appetite suppressants may be trickier. But it's likely that drugmakers will move quickly to get substitutes on the market, even if they dispute the panel's conclusion, which, not surprisingly, they do.

"The results of the Yale study don't rise to the level of scientific documentation needed to make changes in the availability or labeling of PPA," Dr. R. William Soller of the Consumer Healthcare Products Association told me. This despite the fact that his association commissioned the study.

There are still plenty of uncertainties and unanswered questions, such as how much PPA must be consumed before the risk increases and whether the drug accumulates over time. How long this will take to play out is also unclear. The FDA, however, usually follows the advice of its advisory committees. Given the controversial nature of these findings and the large number of consumers affected, you can probably expect some type of resolution within a couple of months.

Until then, if you come down with a cold and have concerns, remember that a box of tissues has never been shown to cause any harm.

Dr. Ian appears on WNBC-TV in New York City. E-mail him at ianmedical@aol.com . For more on PPA, visit www.fda.gov