The Risks for Stroke related to PPA: The Yale Study

The people at highest risk for using PPA products people are woman aged 18 to 49.

A study, conducted by Researchers at Yale University, published in The New England Journal of Medicine, found that women ages 18 to 49 who took PPA as an appetite suppressant were as much as 15 times as likely as other women to suffer hemorrhagic stroke, a type of stroke characterized by bleeding in the brain. First-time users of the ingredient were three times as likely to suffer a stroke.

The Yale study involved 702 patients between the ages of 18 and 49 who had suffered hemorrhagic strokes, or bleeding in the brain. The stroke patients were matched on the basis of age, gender, race and geographic location with control subjects who had not had a stroke.

The study found evidence that linked PPA to the stroke patients, who were 50 percent more likely than the control subjects to have used PPA within three days of the onset of their stroke symptoms.

These risk factors indicate that as many as 200 to 500 people suffer PPA-related strokes each year in the United States.

The FDA Action: November 2000 Warning, Points to a Ban in the next Few Months

On Oct. 19, a panel of scientific experts reviewed the Yale study and, in a series of votes, recommended overwhelmingly that the FDA remove PPA from over-the-counter products. The panel did not consider whether the ingredient should be permitted in prescription drugs.

The FDA warned Americans on November 6, 2000 to quit using dozens of over-the-counter cold remedies and diet pills that contain the ingredient. The FDA's unusually strong health warning says:

"We suggest you stop taking the drug immediately and use an alternative."

-FDA Warning

The legal steps needed for a ban would take a few months, so the FDA asked manufacturers to voluntarily stop selling PPA-containing drugs immediately - and replace the ingredient with a safer alternative. To enact a permanent ban, the FDA must issue a new regulation governing over-the-counter products and seek public comment. It must also initiate separate proceedings to remove the ingredient from prescription drugs. These regulatory moves could take months. But the FDA has calculated that between 200 and 500 strokes each year may be attributable to PPA. So it decided to issue this immediate warning to consumers.

The FDA's warning covers 400 products. Certain formulations of Alka-Seltzer, Dimetapp, Robitussin, Contac and Triaminic contain PPA, as do many generic cold remedies, some prescription decongestants and some children's products. Acutrim and Dexatrim, both appetite suppressants, also contain PPA.

Read Full List >>

In issuing the sweeping public health advisory, FDA officials asked the manufacturers of all PPA products, 100 companies in all, to stop marketing them voluntarily while the agency drafted new regulations to effectively ban the ingredient from all pharmaceuticals.

Drug Manufacturers and Retailers React to the Crisis

Most of the largest pharmacy chains and drug manufacturers began withdrawing cold remedies and appetite suppressants including some that have been staples in medicine cabinets for decades, after federal regulators announced they would take steps to ban all use of the active ingredient in them.

The FDA request sent drug store and pharmaceutical executives scrambling to respond and most are attempting to comply.

Officials at the Walgreens, CVS and Rite-Aid pharmacy chains have said they are immediately removing PPA products from their shelves. And drug-makers SmithKline Beecham and Bristol- Myers Squibb said yesterday that they will no longer market cold products containing the chemical.

Drugstore.com has removed all products containing PPA from its web site.

A spokesman for Bristol-Myers Squibb, which sells the cold remedies Comtrex and Naldecon, said it is already moving to reformulate its products.

PPA, which is similar in structure to amphetamine, has been on the market for more than 50 years, although there have long been concerns about its safety. Until now, however, the FDA has said not enough scientific evidence existed to justify removing it from the market.

The action was based on a five-year study by scientists at Yale, who recently reported that PPA is associated with a small, but significant, increase in the risk of stroke among young women.

Overview of Products

Cold relief drugs, appetite suppressants and dietary aids may contain PPA. Consumers should contact their doctors and/or pharmacists with questions about taking any product containing PPA.

 

Appetite Suppressants

Dexatrim and Acutrim: These diet pills are the only nonprescription appetite suppressants; they contain PPA. Dieters should call their doctors about prescription-only alternatives.

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Overview of PPA | Health Risks and Incidence of Stroke | Full Listing of PPA Products | FDA Warning Notices

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