FDA panel says PPA poses stroke risk

A key ingredient in many over-the-counter cold and diet drugs poses a significant stroke risk and should no longer be sold so freely, a U.S. Food and Drug Administration panel of scientists said today.

The ingredient, called phenylpropanolamine, or PPA, has been the focus of a growing controversy over whether it causes potentially fatal brain bleeding. Earlier this year, a Yale University study seemed to show that the risk was real. And the 14-member Nonprescription Drugs Advisory Committee agreed, saying the compound is too dangerous to be sold without a prescription.

While the panel's vote isn't binding, the agency will review the recommendation and offer a proposed regulation for PPA, says an FDA spokesman. If that proposal is to ban the substance from nonprescription drugs, it must then go through a period of public comment that could take many months.
　　However, Dr. Robert Delap, director of the FDA's Office of Drug Evaluation, said he hopes to complete the review "expeditiously."

PPA is found in dozens of over-the-counter remedies, from cough and cold medicines to appetite suppressants like Dexatrim and Acutrim. The compound is believed to cause inflammation of blood vessels in the brain. It's also implicated in an increase in blood pressure that makes vessels more prone to leaks and ruptures.

Last May, Yale University researchers found that the compound increased the odds of suffering hemorrhagic strokes by about 50 percent. The risk was higher among young women and in people using a PPA product for the first time.

Group insists it's safe

Appetite suppressants with PPA upped the risk of stroke by a factor of 16 in the three-day period after taking the pills, according to the study, which was funded by the Consumer Healthcare Products Association (CHPA), a group that represents makers of nonprescription drugs.

Despite those results, however, the CHPA has insisted PPA is safe when used properly and has criticized the way the researchers analyzed their data.

The study "did not establish a causal relationship between PPA and hemorrhagic stroke," the association says in a statement. "PPA-containing products have been used by millions of consumers over the past 50 years with a very low incidence of serious side effects."

But Dr. Sidney Wolfe, of Public Citizen, a consumer advocacy group that's urging the FDA to remove PPA from all over-the-counter products, calls the problem "really serious."

"Billions of these pills are taken each year," says Wolfe, whose group notes that there is little or no evidence that the products really help promote weight loss.

Public Citizen says the FDA has learned of more than 50 cases of hemorrhagic strokes tied to PPA, but the real figure might be 10 to 15 times higher. In addition, the group claims PPA use can lead to other dangerous complications, including psychosis, heart damage and kidney failure.

Other countries have limited the availability of PPA. In Iceland and Norway, for example, the ingredient is permitted only by prescription to help with nasal symptoms, Public Citizen says.

(From HealthScout)